Pregnancy in renal transplant recipients

Fertility is restored after renal transplantation when good function is achieved. Our aim was to describe the gestations of our transplanted patients, analyzing outcomes and complications as well as long-term evolution of renal function. From 1976 to 2004, 43 gestations occurred in 35 renal transplanted women: their mean age was 31.7 +/- 4.06 years, with a mean time from the transplant to pregnancy of 4.32 years (0.4-13). At conception, all showed normal renal function (SCr 1.05 +/- 0.2 mg/dL). There were 19 abortions (43.8%), 9 of them spontaneous (21%) and 10 therapeutic (six cases for noncompliance with described criteria of European Best Practice Guidelines for Renal Transplantation, especially pregnancy less than 6 months after transplantation). Excluding these six cases of therapeutic abortions, 24 successful pregnancies occurred in 37 women (65.7%), although eight (29.1%) had premature delivery with live fetuses. Arterial hypertension was the most frequently complication (64%). Preeclampsia occurred in nine (37.5%) pregnancies, with proteinuria in five and only two with mild renal function deterioration. The majority of patients received cyclosporine (n = 20) or tacrolimus (n = 19). Since 1996, mycophenolate mofetil and sirolimus were stopped before conception. Birth weight was lower than 2500 g in 33.3% of pregnancies. Every newborn baby was healthy. Afterward, of the 24 patients with successfully pregnancy, 21 (87.5%) have functioning renal transplants at 53.2 months. After delivery, all currently show good renal function (SCr 1.16 +/- 0.35 mg/dL, CrCl 91 +/- 28.45 mL/m). In conclusion, pregnancy in our renal transplant women shows a success rate of 65.6%. However, complications related to arterial hypertension such as preeclampsia are frequent. The incidence of spontaneous abortions was similar to other series (21%). Long-term graft survival does not seem to be negatively affected by pregnancy.     

Impact of pregnancy on the outcome of kidney transplantation

BACKGROUND: There is still controversy over whether pregnancy adversely affects renal transplantation outcomes. We, thus, compared two groups of kidney transplant recipients in terms of patient survival and allograft function: those who did versus did not conceive posttransplant. METHODS: This historical cohort study conducted between 1996 and 2002, divided female kidney transplant recipients of reproductive age into group I (n=86, at least one posttransplant pregnancy) and group II (n=125, no posttransplant pregnancy). The two groups were matched for age, cause of end-stage renal disease (ESRD), treatment protocol, and first creatinine (Cr). All patients received a first transplant and all had a Cr less than 1.5 mg/dL on entry into the study. The subjects were followed for 45.4 +/- 22.0 and 46.3 +/- 19.8 months, respectively (P>.05). Five-year patient and graft survivals and Cr were considered to be the main outcome measures. RESULTS: Mean (SD) age in groups I and II was 26.6 +/- 6.6 and 26.9 +/- 8.1 years, respectively (P>.05). Five-year patient and graft survival rates were not significantly different between the study groups. Of the women in group 1, only 9 (10.5%) subjects displayed elevated serum Cr levels (>1.5 mg/dL) at the end of follow-up, while the serum Cr levels in 35 (28%) group II patients were above 1.5 mg/dL (P=.024). CONCLUSION: Our results indicates pregnancy did not seem to adversely affect patient and graft survival among kidney transplant recipients. Renal transplantation in stable women of childbearing age should not be a contraindication to pregnancy.     

Effect of Pregnancy on Long-Term Kidney Function in Renal Transplant Recipients Treated with Cyclosporine and with Azathioprine

In order to investigate the effect of different immunosuppressive regimens and the time interval between transplantation and pregnancy on long-term outcome, we performed a case-control study in pregnant renal allograft recipients. Eighty-one pregnancies of kidney transplanted recipients were identified [cyclosporine (CYA): n = 40; azathioprine (AZA): n = 41]. Controls were matched with respect to important prognostic factors. Posttransplant follow-up was 91.3 +/- 5 months. Graft and patient survival were similar in both groups and there was no apparent effect of immunosuppression. A total of 28 recipients (33%) delivered within 2 years and 6 (8%) subjects within 1 year after transplantation, but these short transplantation-to-pregnancy intervals had no apparent adverse effect on long-term outcome. In contrast to AZA-treated patients, CYA-treated patients experienced an increase in serum creatinine postpartum (1.15 +/- 0.2 mg/dL vs. 1.61 +/- 0.1 mg/dL; p < 0.05). Whole blood CYA levels decreased transiently during pregnancy from 115.9 +/- 8 ng/mL to 80.7 +/- 7 ng/mL leading to a gradual increase in drug dose from 240 +/- 14 mg/day to 324 +/- 21 mg/day (p < 0.05). Following delivery, there was an increase in CYA concentrations to 173 +/- 5.4 ng/mL, requiring rapid dose tapering to baseline of 246 +/- 15 mg/day. Pregnancies in renal recipients do not affect long-term patient and graft survival, independent of the immunosuppression. No detrimental effect of short transplantation-to-pregnancy intervals on long-term graft function was detected.     

Effect of pregnancy on long-term function of renal allografts.

Pregnancy in renal allograft recipients is associated with hyperfiltration with the potential for glomerular damage and adverse effects on long-term graft prognosis. We have undertaken a case-controlled study of posttransplant follow-up for a mean of 12 years (range, 4 to 23) in 36 female renal allograft recipients, 18 who became pregnant and 18 controls (matched to underlying disease and renal function) who did not. Assessments included plasma creatinine (PCr), glomerular filtration rate (GFR) by infusion clearance of inulin (Cin), mean arterial pressure (MAP), and documentation of antihypertensive therapy. By the end of follow-up, PCr in the pregnancy group (112 +/- 73 mumol/L [1.26 +/- 0.83 mg/dL]) and controls (127 +/- 52 mumol/L [1.44 +/- 0.59 mg/dL]) had increased by 19% and 8%, respectively, and GFR in the pregnancy group (58 +/- 29 mL/min) and controls (56 +/- 32 mL/min) had decreased by 18% and 7%, respectively. Graft loss or chronic rejection occurred in two patients in each group and there was a death in the pregnancy group 9 years after the second of two successful pregnancies. MAP in the pregnancy group (96 +/- 12 mm Hg) had decreased by 1%, and in the controls (101 +/- 9 mm Hg) had increased by 5%. Two patients in the index group and three in the control group commenced antihypertensive therapy during follow-up. There was, therefore, no evidence of an adverse effect of pregnancy in renal allograft recipients on long-term renal function or development of hypertension.     

The pregnancy rate and live birth rate after kidney transplantation: a single-center experience

Kidney transplantation is the treatment of choice for end-stage renal disease (ESRD). Kidney transplantation recipients live longer and have better quality of life than patients on dialysis. Hypothalamic gonadal dysfunction in females who have ESRD may be reversed within the first few months after kidney transplantation, such as the ability to have children. Despite thousands of successful pregnancies in transplantation recipients, there is limited information about it. In this study, we evaluated the pregnancy rates and live birth rates in women (n = 133) who underwent kidney transplantation in our center from 1983 to 2010. Recipients of a second kidney transplantation and recipients of multiorgan transplantations were excluded. We observed 33 pregnancies with 11 live births (33.3%), 12 spontaneous abortions (36.36%), and 10 therapeutic abortions (30.3%). The pregnancy rate was 18%. The live birth rate was 33.3%. Therapeutic abortions were 36.3%, and the pregnancies resulting in fetal loss were 30.3%. The pregnancies were identified in 32 women. The majority of women (n = 32; 96.9%) had a single pregnancy, whereas 1 woman (3.1%) had two pregnancies. In our series, the pregnancy rates for kidney transplantation recipients were markedly lower and decreased more rapidly than those reported in the general population.     

Pregnancy after liver transplantation: report of 8 new cases and review of the literature

Improved survival and quality of life following liver transplantation are associated with an increased frequency of pregnancies in liver-transplanted women. We investigated the outcome, complications, and management of those pregnancies. We have reviewed the literature and report 8 pregnancies in 6 transplant recipients. Seven pregnancies were completed at 38+/-2 (mean+/-standard deviation) weeks. One miscarriage occurred at week 12. Newborns' weight averaged 2938+/-156 g. Main complications were preeclampsia (n=1) and reversible cholestasis (n=1). Among 285 pregnancies reported in literature, 78+/-20% were successful and the main complications were: preeclampsia (26+/-19%), hypertension (28+/-19%), reversible liver dysfunction (27+/-21%), cesarean delivery (23+/-10%), preterm birth (31+/-28%), small for gestational age infants (23+/-10%), rejection (10+/-7%). Gestational weeks were 36.7+/-1.3, perinatal mortality was 4+/-10%, malformation rate 3%. The rates of both abortions and complications (preeclampsia and/or hypertension) were inversely related to the time interval between transplantation and conception (p<0.05). Abortions occurred more often in recipients whose underlying disease was autoimmune cirrhosis than in recipients with inherited disorders. Rejection rate was approx. 10%, which appears higher than reported in a non-pregnant population after a comparable time interval from transplant (2-3%). Up to 28 months after delivery, maternal death was 5.5+/-7%. We conclude that: the time intervals between transplantation and conception as well as the original cause of liver failure influence the outcome and complications of pregnancies in liver recipients. However, neonatal survival is high, while malformations are relatively rare.     

Unwanted pregnancy among kidney transplant recipients in Iran

To investigate the incidence of unwanted pregnancy among kidney transplant recipients, we studied 86 pregnancies in 64 women with a transplanted kidney. Twenty-five pregnancies were unwanted (29.1%). Pregnancy was terminated by induced abortion in seven patients, and four pregnancies were lost due to spontaneous abortion with one intrauterine fetal death. Only 13 (52%) pregnancies resulted in a live birth. Most of the unwanted pregnancies occurred in women using coitus interruptus (92%) as the only method of contraception. It is concluded that because fertility greatly improves after kidney transplantation, it is necessary to have a family planning counseling session before surgery. If a patient is not interested in future pregnancy, an effective method of contraception should be offered. A woman who has decided against childbearing in the future may decide to have a tubal ligation at the time of transplantation surgery.     

Prednisone dosage and pregnancy outcome in renal allograft recipients

BACKGROUND: The literature contains reports of 2309 pregnancies in some 1600 women who have undergone renal transplantation. Certain pre- pregnancy factors, especially hypertension, renal graft dysfunction, short interval between transplant and pregnancy, and high immunosuppressive drug dosage, appear to increase the neonatal risks. METHOD: We describe the outcome of 42 pregnancies in 27 allograft recipients at Rabin Medical Center (Beilinson Campus) in Israel during the last 8 years. All were treated with combination immunosuppression regimens. RESULTS: The average interval from transplantation to conception was 3.7 +/- 0.4 years (2 months to 9 years). Rejection episodes occurred in 37% prior to pregnancy but in none during or immediately after pregnancy. Twenty-eight percent of the pregnancies ended in therapeutic or spontaneous abortions, and 29 of the 30 deliveries ended in a live birth. The prematurity rate (63%) was similar to that described in the literature for this patient group. Renal deterioration was evident in seven women (26%) within 2 years after delivery. Use of 7.5 mg/d prednisone (vs. 10 mg/d) before pregnancy was observed as the most significant preconception parameter related to better pregnancy outcome. A long interval from transplantation to conception and lack of pre-existing hypertension were also significant. CONCLUSION: The better pregnancy outcome associated with lower prednisone dosage is probably related to the fact that the patients selected to receive the low-dose regimen have had a longer and less complicated post-transplantation course.      

The Pregnancy Rate and Live Birth Rate in Kidney Transplant Recipients

Fertility is one of the potential benefits for women undergoing kidney transplantation; however, population-based information about the likelihood of pregnancy and successful fetal outcome is not available. In this observational study of 16 195 female kidney transplant recipients aged 15–45 years in the United States between 1990 and 2003, we determined the pregnancy rate and live birth rate using Medicare claims data from the first three posttransplant years. The pregnancy rate was 33 per thousand female transplant recipients between 1990 and 2003 and progressively declined from 59 in 1990 to 20 in 2000. The live birth rate between 1990 and 2003 was 19 per thousand female transplant recipients and declined in parallel with the pregnancy rate. Despite a decrease in therapeutic abortions over time, the proportion of pregnancies resulting in fetal loss (45.6%) remained constant during the study due to an increase in spontaneous abortions and other causes of fetal loss. The pregnancy rate in kidney transplant recipients was markedly lower and declined more rapidly than reported in the general American population during the same period. The live birth rate was substantially lower than reported in voluntary registries of transplant recipients, and the proportion of pregnancies resulting in unexpected fetal loss increased over time.     

Pregnancy after lung transplant

The purpose of this study was to analyze pregnancy outcomes in female lung transplant recipients. Data were collected from the National Transplantation Pregnancy Registry via questionnaires, interviews, and hospital records. Twenty-one female lung recipients reported 30 pregnancies with 32 outcomes (1 triplet pregnancy). Outcomes included 18 live births, 5 therapeutic abortions, and 9 spontaneous abortions. No stillbirths or ectopic pregnancies were reported. Mean (SD) interval from transplant to conception was 3.6 (3.3) years (range, 0.1-11.3 years). Comorbid conditions during pregnancy included hypertension in 16, infections in 7, diabetes in 7, preeclampsia in 1, and rejection in 5 women. Ten of the 21 recipients received a transplant because of cystic fibrosis and accounted for 12 pregnancy outcomes (7 live births, 3 spontaneous abortions, and 2 therapeutic abortions). At last recipient contact, 13 had adequate function, 2 had reduced function, 5 recipients had died (2 with cystic fibrosis), and 1 recipient had a nonfunctioning transplant. Mean gestational age of the newborn was 33.9 (SD, 5.2) weeks, and 11 were born preterm (<37 weeks). Mean birthweight was 2206 (SD, 936) g and 11 were low birthweight (<2500 g). Two neonatal deaths were associated with a triplet pregnancy; one fetus spontaneously aborted at 14 weeks and 2 died after preterm birth at 22 weeks. At last follow-up, all 16 surviving children were reported healthy and developing well. Successful pregnancy is possible after lung transplant, even among recipients with a diagnosis of cystic fibrosis.     

Pregnancy and childbearing in a population with biologic valvular prostheses

Long-term performance of biological prostheses and course of pregnancy, labor, and delivery were evaluated in women less than 35 years of age. Between 1975 and 1987, 87 female patients received a porcine (n = 86) or pericardial valve (n = 1); the mean patient age was 26.8 years, with a range of 8 to 35 years. A total of 17 of these patients experienced 37 pregnancies. A total of 25 babies were delivered, of which 19 were babies of normal birth weight born at term and six were born prematurely (two of these were stillborn). There were six spontaneous abortions and five therapeutic abortions. The mean time from primary operation to first delivery was 29 months. Of the 17 pregnant patients, 14 were in normal sinus rhythm and three were in atrial fibrillation. One of those in fibrillation had a therapeutic abortion while receiving warfarin therapy, and another was successfully delivered of her neonate after 7 months of warfarin therapy. The remaining 15 patients were treated through 35 pregnancies without anticoagulants or antiplatelet agents. Of the total population of 87 patients, 32 (36.8%) were treated for valve-related complications. Structural valve deterioration occurred in eight patients (47.1%) of the pregnancy group and 10 patients (14.3%) of the nonpregnancy group (p less than 0.05). The freedom from structural valve deterioration at 10 years was 23.3% +/- 14% for the pregnancy group and 74.2% +/- 8.5% for the nonpregnancy group (p less than 0.05, age as a determinant, p not significant). There were eight valve-related deaths (1.5%/patient-year). Reoperation was performed in 59% of the pregnancy group and 19% of the nonpregnancy group, primarily for structural valve deterioration manifested as valvular obstruction from aggressive calcification (p less than 0.05). The freedom from reoperation at 10 years parallels freedom from structural valve deterioration (20.3% +/- 12.4% and 64.3 +/- 9.1% for the pregnancy and nonpregnancy groups, respectively, with p less than 0.05; with age added as a determinant, p not significant). The overall reoperative mortality was 8.7% (two patients). The biologic prostheses afforded successful pregnancy without fetal wastage or congenital anomalies and without significant maternal morbidity or mortality.     

Safe for Mother,Baby, and Graft? Pregnancy After Liver Transplant: A Single-Center Experience

BackgroundAlthough fertility is reduced in patients with liver cirrhosis, recovery of menstrual cycle is acquired after liver transplantation (LT) in most patients, and pregnancy in LT recipients is not unusual. The aim of this study was to evaluate the outcomes of pregnancies in LT recipients in our center.MethodsData of 24 pregnancies in 14 LT recipients were collected and statistically analyzed. Demographic and clinical data were documented in each trimester of pregnancy and thereafter. The analysis was conducted in accordance with the 1975 Declaration of Helsinki and was approved by the ethics committee of the University Hospital Essen.ResultsMedian patient age was 21.5 years (range, 2-32 years) at LT and 31 years (range, 19-41 years) at conception. Median time between LT and conception was 126 months (range, 38-332 months), and median gestation time of completed pregnancies was 38 weeks (range, 29-40 weeks). Seven pregnancies terminated in abortions (29%). Of all deliveries, 6 resulted in preterm births (35%) with median gestation time of 34.5 weeks (range, 29-37 weeks). Gestational diabetes mellitus was the most common maternal complication, occurring in 4 patients (17%). One patient suffered from preeclampsia (4%). Pregnancy-induced hypertension or acute cellular rejection was not reported in our cohort. None of the children had serious complications.ConclusionsOur data show favorable outcome for pregnancy in LT recipients for mother and offspring. However, these patients are still at risk, particularly regarding high rates of preterm delivery, and preconception counseling and multidisciplinary monitoring are crucial to manage possible complications.     

Effects of immunosuppressive drugs on serum lipid levels in renal transplant recipients

BACKGROUND: Hyperlipidemia is an important metabolic disorder that is common among renal transplant recipients. This study investigated the possible effects of transplantation and immunosuppressive drugs on lipid profiles in this patient group. METHODS: We retrospectively evaluated the records of 179 patients who underwent renal transplantation between 1996 and 2000, recording lipid profile findings-total cholesterol (TC), low-density lipoprotein cholesterol (LDLc), high-density lipoprotein cholesterol (HDLc), and triglyceride (TG)-before and at least 6 months after transplantation. We also recorded patient demographics, underlying renal disorder, and immunosuppressive drug regimens. RESULTS: Sixty-nine (38.5%) patients were women and 110 men (61.5%). The mean age (+/- SD) of the 179 recipients was 35.7 +/- 11.8 years (range, 11 to 62 years). The respective pre- versus posttransplantation lipid profile findings were: TC, 171.6 +/- 42.4 mg/dL versus 204.7 +/- 45.3 mg/dL, P < .001; LDLc, 114.5 +/- 34.5 mg/dL versus 142.2 +/- 39.7 mg/dL, P < .001; HDLc, 46.7 +/- 13.6 mg/dL versus 42.5 +/- 12.3 mg/dL, P = .001; TG, 142.9 +/- 55.7 mg/dL versus 178.8 +/- 71.8 mg/dL, P < .001. Increased lipid levels were found to be independent of patient age, sex, donor type, and immunosuppressive drug regimen. CONCLUSION: The results suggested that antihyperlipidemic drugs should be administered routinely to renal transplant recipients irrespective of the immunosuppressive drug regimen or graft source.     

Predictive factors for adverse pregnancy outcomes after renal transplantation

Several predictive factors associated with adverse pregnancy outcomes in female renal recipients have been suggested. Our study aimed to determine the most important factor for prediction of adverse pregnancy outcomes in female renal recipients. We studied 41 pregnancies in 29 female renal recipients retrospectively. We reviewed pregnancy outcomes and possible predictive factors including pre‐pregnancy serum creatinine (SCr), pre‐pregnancy glomerular filtration rate (GFR), pre‐pregnancy hypertension, pre‐pregnancy proteinuria, transplantation‐pregnancy interval and type of immunosuppressants. We defined an adverse pregnancy‐related outcomes index (APOI) that included the following conditions: (i) preeclampsia; (ii) fetal growth restriction (FGR); (iii) prematurity before 34 wk of gestation; (iv) fetal loss (v) graft dysfunction during pregnancy or within three months from delivery. The cutoff of pre‐pregnancy serum creatinine and GFR was determined by receiver operating characteristics curves for the prediction of each adverse outcome and APOI. Only pre‐pregnancy serum creatinine was associated with adverse pregnancy outcome, and 1 mg/dL was determined to be a useful cutoff for the prediction of each adverse outcomes. Pre‐pregnancy SCr ≥ 1 mg/dL was associated with 7.7 times increased risk of preeclampsia and 6.9 times increased risk of APOI. Pre‐pregnancy serum creatinine is the most powerful predictive factor for adverse pregnancy outcomes, and <1 mg/dL may be used as a screen for successful pregnancy outcome.     

Pregnancy in lung transplant recipients

Eight female lung transplant recipients, all of whom became pregnant after transplant, were reported to the National Transplantation Pregnancy Registry from US transplant centers. Outcomes of the 8 pregnancies were 4 live births, 3 therapeutic abortions, and 1 spontaneous abortion. Three of the 4 newborns were premature, with low birth weight (< 2500 grams). Rejection during pregnancy occurred in 3 pregnancies (38%). All 8 transplant recipients reported at least 1 complication during pregnancy, including shortness of breath, rejection, and infection. Two of the 4 deliveries were by cesarean section. At follow-up, all children were developing well with no residual problems. Female lung transplant recipients may face higher risks during pregnancy than other solid organ transplant recipients.     

Pregnancy in kidney transplant recipients

PURPOSE: Our aim was to investigate kidney allograft, obstetric, and maternal outcomes in pregnant women undergoing kidney transplantation in our center. METHODS: Retrospective data on 74 pregnancies in 60 patients were reviewed and completed through phone interviews were compared with information on a control group of female kidney recipients. RESULTS: Mean age of patients at transplantation was 26.55 +/- 4.72 years and the median interval between transplantation and pregnancy was 27.5 months. Gestational period was 8 months. Live birth was the outcome in 43.2% of pregnancies; 9.5% led to still birth, 24.3% were aborted, and obstetrical data of the remaining were unavailable. Among the 11 patients who became pregnant within 12 months after transplantation, we observed seven live births and four abortions. None of pregnancies that were accompanied by acute rejection episodes (ARE) were successful. Twenty-six patients experienced at least one ARE versus 23 patients of the control group (P = NS). However, the first ARE occurred later in the pregnant group (P = .028). Chronic rejection and graft loss were seen in 24 and 18 study group cases and 17 and 17 control cases, respectively (P = NS). One-, 3-, 5-, and 10-year graft survivals were 100%, 96.5%, 94.5%, and 77.1% in the pregnant group versus 93.2%, 85.7%, 81%, and 64.7% in the control group, respectively (P = .07). CONCLUSION: Pregnancy in kidney recipients seems to be safe for kidney allograft recipients even within the first year posttransplant. Nonetheless, the outcomes of pregnancy in this group of patients is not always favorable, especially when rejection occurs simultaneously.     

Pregnancy after renal transplantation: A single-center experience

Objectives:   To examine women with renal transplants who became pregnant, and delivered at our hospital.
Methods:   Twenty-six women who had undergone renal transplantation between 1977 and 2002 became pregnant, and delivered at Osaka University Hospital. Complete medical records of twenty of them were retrieved and retrospectively analyzed.
Results:   Overall, twenty-nine pregnancies occurred in these twenty women after renal transplantation. There were spontaneous abortions in three cases, whereas pregnancy was artificially terminated five times. Thus, neonates were delivered in 21 of 29 pregnancies. One woman delivered twice and two women delivered twins. As a result, a total of 23 neonates were delivered. Mean gestational period was 35.4 weeks (range, 27–41 weeks), and mean birth weight was 2229 g (range, 724–3544 g). Regarding fetal complications, intrauterine growth retardation was observed in three cases. One child with intrauterine growth retardation died at 3 months old due to respiratory distress syndrome. One child displayed double-outlet right ventricle and another child had congenital unilateral hydronephrosis. Regarding maternal complications, prevalence of toxemia of pregnancy was 38.1%. In four of the 21 deliveries (19.0%), renal function exacerbated after delivery. Rates of graft survival for the 20 women at 1, 5 and 10 years after delivery were 100%, 85.1% and 74.4%, respectively. Prognosis for renal transplant resulted to be significantly poorer for recipients with hypertension before pregnancy than for recipients without hypertension before pregnancy (log-rank test, P  = 0.043).
Conclusions:   Rates of graft survival after delivery were mostly favorable. However, prognosis for renal function was poorer for recipients who displayed hypertension prior to pregnancy.     

Renal function and safety of heart transplant recipients switched to mycophenolate mofetil and low-dose cyclosporine

BACKGROUND: We evaluated cyclosporine (CSA) dose reduction and mycophenolate mofetil (MMF) treatment versus maintained CSA dosage and azathioprine (AZA) in HTX regarding renal function and safety from CSA nephrotoxicity (creatinine > 1.7 mg/dL). METHODS: Fourteen recipients (group 1: 12 men, 2 women) with CSA-based immunosuppression (plus azathioprine and/or steroids) were started on 2000 mg MMF/d. Azathioprine was discontinued and CSA tapered to trough whole blood levels of 70 to 120 microg/L. Ten recipients (group 2: seven men, three women) were maintained on their CSA dosages. Creatinine clearance, serum creatinine, uric acid, urea nitrogen, and rejection were monitored. RESULTS: Mean age was 58 (range 44 to 69 years) and 48 years (range 24 to 61 years) in groups 1 and 2, respectively. In group 1 creatinine fell from 2.7 +/- 0.8 to 1.9 +/- 0.5 mg/dL (baseline vs control 2: P =.001); uric acid and urea nitrogen remained constant. CSA levels decreased from 173 +/- 56 to 110 +/- 33 microg/L (P =.02). In group 2 creatinine (2.4 +/- 0.7 vs 2.3 +/- 0.5 mg/dL), uric acid, urea nitrogen, and CSA levels remained constant. Comparison between groups showed higher creatinine clearance (50 +/- 18 vs 29 +/- 14 mL/min; group 1 vs group 2: P =.02), lower CSA levels (110 +/- 33 vs 161 +/- 35 microg/L; P <.001) and a trend toward lower serum creatinine (1.9 +/- 0.5 vs 2.3 +/- 0.5 mg/dL, P =.077). There were two rejections >/= 1B according to ISHLT in the study and four in the control group. Two deaths occurred in each group. CONCLUSIONS: Conversion from AZA to MMF after CSA reduction improves creatinine clearance in HTX recipients and reduces serum creatinine. No negative effect on patient safety was identified by rejection rate or survival.     

Single-center, open, prospective, randomized pilot study comparing cyclosporine versus tacrolimus in simultaneous pancreas-kidney transplantation

BACKGROUND: Although tacrolimus (Prograf) is the calcineurin inhibitor usually employed in simultaneous pancreas-kidney transplantation (SPKTx), no prospective randomized studies have compared its efficacy to cyclosporine (Neoral), when either drug is used in combination with mycophenolate mofetil (MMF) and the pancreas is drained into the portal vein. METHODS: Between May 2001 and June 2003, 16 SPKTx recipients were randomized to be prescribed Neoral and 17 Prograf in addition to basiliximab, steroids, and MMF. All pancreata were drained into the portal vein. RESULTS: After a median follow-up of 15.6 months, six kidney acute rejection episodes were observed with Prograf (36.5%; one steroid-resistant) and one Neoral (n = 1, 6.2%; P =.04). No pancreas rejection episode was recorded. Two infections occurred in two recipients from each group. No major adverse events were noted other than a severe hematological toxicity (Prograf). Metabolic parameters were equivalent in the two groups, save for higher total cholesterol (212 +/- 39 mg/dL vs 173 +/- 23 mg/dL; P =.008), LDL (129 +/- 33 mg/dL vs 101 +/- 21 mg/dL; P =.029), and triglyceride (191 +/- 86 mg/dL vs 126 +/- 40 mg/dL; P =.028), values with Neoral, although the same differences were already present at baseline. One recipient (Neoral) died with functioning grafts. Patient, pancreas, and kidney survival rates were all 94% for Neoral versus 100% for Prograf. CONCLUSIONS: Although a larger series and a longer follow-up are needed, Neoral and Prograf used in combination with MMF seem to achieve equivalent success rates among primary SPKTx when the pancreas is drained into the portal vein.