阿法迪三冲击和每日治疗对血液透析患者继发性甲旁亢疗效的随机多中心对照临床研究

目的评价阿法迪三(R)[lα-(OH)-D3]每日或冲击治疗血液透析患者继发性甲状旁腺功能亢进(甲旁亢)的有效性和安全性.方法选择158例维持性血透患者,血全段甲状旁腺激素(iPTH)水平＞200 pg/ml,随机分为冲击组和每日组,分别采用阿法迪三(R)2μgbiw～tiw口服和0.5μgqd口服治疗,总观察期为20周,终点指标为iPTH水平＜200ph/ml.分别检测治疗前后血iPTH及钙磷代谢相关指标,并对不良反应进行监测.结果(1)两组患者年龄、透析龄、基础肾病分布、曾接受活性Vit D3治疗比例、平均血iPTH水平[冲击组(570.47±295.86)pg/ml,每日组(498.33±207.84)pg/ml]及血钙血磷等生化指标均无显著性差异.(2)冲击组治疗4周达标率明显高于每日组(35.2%比19.4%,P＜0.05).治疗至终点时两组总达标率相比无明显差异.iPTH%/周水平在iPTH 200～500pg/ml亚组冲击法高于每日法[(10.68±7.32)%比(7.42±7.89)%,P＜0.05].治疗终点时两组患者碱性磷酸酶(AKP)水平均较治疗前明显下降.(3)治疗终点和治疗前相比,每日组血磷、钙磷乘积均上升,而冲击组治疗前后无明显差异.(4)两组患者不良反应轻微.结论 (1)阿法迪三(R)(1α-(OH)-D3)口服和冲击治疗均能有效控制血透患者继发性甲旁亢,安全性良好.(2)早期冲击疗法对于血透患者中度继发性甲旁亢患者疗效更显著,起效更快.     

No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: a randomized crossover trial

Alfacalcidol and paricalcitol are vitamin D analogs used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease, but have known dose-dependent side effects that cause hypercalcemia and hyperphosphatemia. In this investigator-initiated multicenter randomized clinical trial, we originally intended two crossover study periods with a washout interval in 86 chronic hemodialysis patients. These patients received increasing intravenous doses of either alfacalcidol or paricalcitol for 16 weeks, until parathyroid hormone was adequately suppressed or calcium or phosphate levels reached an upper threshold. Unfortunately, due to a period effect, only the initial 16-week intervention period for 80 patients was statistically analyzed. The proportion of patients achieving a 30% decrease in parathyroid hormone levels over the last four weeks of study was statistically indistinguishable between the two groups. Paricalcitol was more efficient at correcting low than high baseline parathyroid hormone levels, whereas alfacalcidol was equally effective at all levels. There were no differences in the incidence of hypercalcemia and hyperphosphatemia. Thus, alfacalcidol and paricalcitol were equally effective in the suppression of secondary hyperparathyroidism in hemodialysis patients while calcium and phosphorus were kept in the desired range.     

Conversion of oral alfacalcidol to oral calcitriol in the treatment of secondary hyperparathyroidism in chronic hemodialysis patients

International Urology and Nephrology - The optimal vitamin D3 therapy for the treatment of secondary hyperparathyroidism (SHPT) in chronic hemodialysis patients is still controversial. Recent...     

A clinical study on active vitamin D pulse therapy in hemodialysis patients with secondary hyperparathyroidism

The oral active vitamin D pulse therapy was performed for 20 chronic hemodialysis patients with secondary hyperparathyroidism (2 degrees HPT). Before pulse therapy, all patients showed high-turnover bone diseases, elevated serum alkaline phosphatase (Alp) and elevated serum parathyroid hormone (PTH). They had at least one parathyroid gland detected by ultrasonography. In one patient, serum PTH level did not decrease during three months. In five patients, hypercalcemia was observed so that the pulse therapy was with drawn. Another patient was resistant to the second pulse therapy for recurrence of 2 degrees HPT. Total parathyroidectomy and autotransplantation was performed in these seven patients. The size of parathyroid gland in patients undergoing surgical treatment was significantly larger than those estimated by ultrasonography in patients successfully treated with pulse therapy (p < 0.005). In all patients with surgical treatment, the conventional oral active vitamin D therapy was performed with caution to hypercalcemia preoperatively. The preoperative Alp levels decreased compared with those of at the beginning of the pulse therapy. Postoperatively, the total amount of intravenous administered calcium decreased, and serum calcium levels were easily controlled.     

Prospective comparison of the effects of maxacalcitol and calcitriol in chronic hemodialysis patients with secondary hyperparathyroidism: a multicenter, randomized crossover study

BACKGROUND: Maxacalcitol is a vitamin D analogue, which is administered intravenously for secondary hyperparathyroidism in dialysis patients as well as calcitriol. However, few dose-comparison clinical studies have been reported for these drugs. The present multicenter, randomized crossover study was conducted to determine the equivalence of maxacalcitol and calcitriol doses. METHODS: Subjects comprised 31 patients on chronic hemodialysis with secondary hyperparathyroidism who had not received maxacalcitol or calcitriol in the previous 3 months. Patients were randomly divided into two groups, and maxacalcitol or calcitriol was administered in a crossover design for 12 weeks each. Maxacalcitol and calcitriol doses were adjusted based on serum levels of calcium and intact parathyroid hormone. RESULTS: After the 12-week maxacalcitol/calcitriol administration, there were no significant differences in levels of calcium (maxacalcitol 2.40+/-0.22 mmol/1 (9.6+/-0.9 mg/dl), calcitriol 2.42 + 0.25 mmol/l (9.7+/-1.0 mg/dl), p = 0.71), phosphate (maxacalcitol 1.97 + 0.42 mmol/l (6.1+/-1.3 mg/dl), calcitriol 2.00+/-0.48 mmol/l (6.2+/-1.5 mg/dl), p = 0.64), intact parathyroid hormone (maxacalcitol 267+/-169 pg/ml, calcitriol 343+/-195 pg/ml, p = 0.11) in serum or other bone-metabolic parameters such as serum alkaline phosphatase. The doses ofmaxacalcitol and calcitriol were 49.3+/-23.7 microg/month and 9.0+/-3.8 microg/month, respectively, and maxacalcitol : calcitriol dose ratio was 5.5: 1. No severe adverse reactions were seen for either maxacalcitol or calcitriol during the study period. CONCLUSIONS: Comparable therapeutic efficacy can be obtained in the treatment of secondary hyperparathyroidism using either maxacalcitol or calcitriol at a dose ratio of 5.5 : 1.     

Blood volume controlled hemodialysis in hypotension-prone patients: a randomized,multicenter controlled trial

BACKGROUND: Recently we have devised and tested a biofeedback system for controlling blood volume (BV) changes during hemodialysis (HD) along an ideal trajectory (blood volume tracking, BVT), continuously modifying the weight loss rate and dialysate conductivity. This multicenter, prospective, randomized, crossover study aimed to clarify whether BVT (treatment B) can improve hypotension-prone patients' treatment tolerance, compared with conventional hemodialysis (treatment A). METHODS: Thirty-six hypotension-prone patients enrolled from 10 hemodialysis (HD) centers were randomly assigned to either of the study sequences ABAB or BABA, each lasting four months. RESULTS: A 30% reduction in intradialytic hypotension (IDH) events was observed in treatment B as compared with A (23.5% vs. 33.5%, P = 0.004). The reduction was related to the number of IDH in treatment A (y = 0.54x + 5; r = 0.4; P < 0.001): the more IDH episodes in treatment A, the better the response in treatment B. The best responders to treatment B showed pre-dialysis systolic blood pressure values higher than the poor responders (P = 0.04). A 10% overall reduction in inter-dialysis symptoms was obtained also in treatment B compared to A (P < 0.001). Body weight gain, pre-dialysis blood pressure, intradialytic weight loss as well as Kt/V did not differ between the two treatments. CONCLUSIONS: An overall improvement in the treatment tolerance was observed with BVT, particularly intradialytic cardiovascular stability. Patients with the highest incidence of IDH during conventional HD and free from chronic pre-dialysis hypotension seem to respond better. Inter-dialysis symptoms also seem to improve with control of BV.     

Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study

Management of secondary hyperparathyroidism is challenging with traditional therapy. The calcimimetic cinacalcet HCl acts on the calcium-sensing receptor to increase its sensitivity to calcium, thereby reducing parathyroid hormone (PTH) secretion. This phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluated the efficacy and safety of cinacalcet in hemodialysis (HD) and peritoneal dialysis (PD) patients with PTH > or =300 pg/ml despite traditional therapy. A total of 395 patients received once-daily oral cinacalcet (260 HD, 34 PD) or placebo (89 HD, 12 PD) titrated from 30 to 180 mg to achieve a target intact PTH (iPTH) level of < or =250 pg/ml. During a 10-wk efficacy assessment phase, cinacalcet was more effective than control for PTH reduction outcomes, including proportion of patients with mean iPTH levels < or =300 pg/ml (46 versus 9%), proportion of patients with > or =30% reduction in iPTH from baseline (65 versus 13%), and proportion of patients with > or =20, > or =40, or > or =50% reduction from baseline. Cinacalcet had comparable efficacy in HD and PD patients; 50% of PD patients achieved a mean iPTH < or =300 pg/ml. Cinacalcet also significantly reduced serum calcium, phosphorus, and Ca x P levels compared with control treatment. The most common side effects, nausea and vomiting, were usually mild to moderate in severity and transient. Once-daily oral cinacalcet was effective in rapidly and safely reducing PTH, Ca x P, calcium, and phosphorus levels in patients who received HD or PD. Cinacalcet offers a new therapeutic option for controlling secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.     

Effect of pulse therapy using 1 alpha(OH)D on secondary hyperparathyroidism in patients on maintenance hemodialysis

The effect of pulse therapy on severe secondary hyperparathyroidism related to chronic renal failure has been examined in 11 patients on maintenance hemodialysis by using an oral administration of 8 micrograms of 1 alpha(OH)D maximum per week. Throughout the 10 months of this treatment, the serum levels of intact-PTH, HS-PTH, and C-PTH were followed up. Additionally, to estimate the peak level of 1,25(OH)2D, its serum concentration at 10 hours after the 1 alpha (OH)D ingestion was measured. Results have shown that the serum levels of the intact-PTH, HS-PTH, and C-PTH were lowered in 9 of these 11 patients, two of this number especially showing a marked suppression of the serum intact-PTH to a low that was near to the normal upper limit level. In the two other cases of these 11 patients, no suppression was seen in any of serum PTH levels throughout the 10 months. In the cases that showed a good response, the 1,25(OH)2D serum concentration elevated significantly, to more than 100 pg/ml at 10 hours after the 1 alpha (OH)D intake. In contrast, in the 2 cases that showed no response, no appreciable elevation in the serum concentrations was noted. Thus, since the pulse therapy using 1 alpha (OH)D decreased the serum levels of the intact-PTH, HS-PTH, and C-PTH in 9 out of the 11 cases, we have concluded that pulse therapy using 1 alpha(OH)D is a valid therapy for secondary hyperparathyroidism in patients on maintenance hemodialysis.     

帕立骨化醇治疗维持性血液透析患者继发性甲状旁腺功能亢进症的前瞻性研究

目的 观察帕立骨化醇治疗维持性血液透析患者继发性甲状旁腺功能亢进症（secondary hyperparathyroidism,SHPT）的疗效及安全性.方法 选择我科血液净化中心进行维持性血液透析治疗的13例患者,血全段甲状旁腺素（intact parathyroid hormone,iPTH）≥33 pmol/L,血钙水平＜2.55 mmol/L,钙磷乘积＜65,根据iPTH水平使用帕立骨化醇1～18 μg治疗,于每次透析治疗后给药,共观察12周.分别于治疗前及治疗后第2、4、6、8、10、12周测定患者的iPTH、血钙、血磷水平.结果 13例患者的血清iPTH水平在治疗后第2、4周已开始下降,但与治疗前相比差异无统计学意义.从治疗后第6周开始,iPTH水平与治疗前相比存在统计学差异（P＜0.05）,治疗后第12周时下降至（46.68±38.06） pmol/L,与治疗前（78.30±52.13） pmol/L比较,有统计学差异（P＜0.01）.治疗后第2、4周血钙水平升高,与治疗前比较有统计学差异（P＜0.05）,其中治疗后第4周时血钙水平升高尤为显著（P＜0.01）.经调整帕立骨化醇剂量后,治疗后第6周患者的血钙水平逐渐恢复正常并保持稳定,血磷、钙磷乘积水平在治疗前、后均无明显统计学差异.治疗过程中,患者耐受性良好,无相关不良反应的发生.结论 使用帕立骨化醇治疗维持性血液透析患者SHPT是有效、安全的.     

维持性血液透析患者继发性甲旁亢的手术治疗疗效观察

目的 回顾性总结维持性血液透析患者继发性甲状旁腺功能亢进症(secondary hyperparathyroidism,SHPT)行甲状旁腺切除术(parathyroidectomy,PTX)的临床疗效.方法 收集2009年10月～2013年11月的25例血液透析患者(平均透析龄58±18.7个月;平均年龄45.6±8.3岁).监测术后并发症及复发情况.对比分析患者术前及术后1个月、3个月、6个月的临床症状、全段甲状旁腺激素(intact parathyroid hormone,iPTH)、血清钙、血清磷及碱性磷酸酶等变化.结果 25例患者中,甲状旁腺全切术共24例(占96％),甲状旁腺全切加前臂自体移植术1例(占4％).术后围手术期无死亡发生.术后绝大部分患者的骨痛及皮肤瘙痒症状在数天内缓解,但随着随访时间的延长,术前颈部彩色超声示小于4枚甲状旁腺结节性增大的5例患者骨痛症状均有复发(20％),但程度较术前明显减轻.2例患者出现一过性声音嘶哑(发生率8％).术后全部患者均出现低钙血症(发生率100％),经积极补钙治疗后均可有效控制.25例患者术前均表现为明显增高的iPTH、血清钙、血清磷和ALP.术后iPTH(P＜0.01)、血清钙(P＜0.01)、血清磷(P＜0.01)和ALP(P＜0.01)水平均较术前显著降低.随访6个月,5例复发(20％),且均为术前检查小于4枚甲状旁腺结节性增大的患者.结论 PTX治疗维持性血液透析患者继发性甲旁亢是一种相对安全和有效的方法,但其长期疗效仍有待于进一步观察.     

Calcium balance during pulse alfacalcidol therapy for secondary hyperparathyroidism in CAPD patients treated with 1.0 and 1.25 mmol/L dialysate calcium

Hypercalcemia frequently occurs in continuous ambulatory peritoneal dialysis (CAPD) patients treated with calcium carbonate and vitamin D metabolites. To reduce the incidence of this complication, it has been proposed to use dialysate solutions with a low calcium concentration. However, there is concern that these solutions may lead to a negative calcium balance. We measured calcium balance in 13 CAPD patients with secondary hyperparathyroidism who were treated with calcium carbonate and alfacalcidol, 2 microg twice weekly, while using 1.0- (1.0 group) and 1.25-mmol/L (1.25 group) dialysate calcium solutions. Calcium absorption was measured after the administration of Ca47. Results for the 1.0 (n = 6) and 1.25 (n = 7) groups included fractional calcium absorptions of 0.14 (range, 0.09 to 0.27) and 0.08 (range, 0.03 to 0.40; P = not significant [NS]) and calcium absorptions of 380 +/- 92 and 331 +/- 83 mg/d (P = NS). Dialysate calcium losses were 93 +/- 20 and 91 +/- 26 mg/d, and total calcium losses (dialysate and urine) were 106 +/- 16 and 108 +/- 40 mg/d (P = NS). Calcium balance was positive in all patients (274 +/- 92 and 223 +/- 65 mg/d; P = NS). These data suggest that the use of 1.0- and 1.25-mmol/L calcium solutions in conjunction with calcium carbonate and pulse alfacalcidol therapy is associated with a positive calcium balance in CAPD patients.     

Randomized trial comparing pulse calcitriol and alfacalcidol for the treatment of secondary hyperparathyroidism in haemodialysis patients

Aim: Calcitriol and alfacalcidol are used extensively for the treatment of secondary hyperparathyroidism. Unfortunately, there is limited published data comparing the efficacy and tolerability of both active vitamin D sterols. This study was undertaken to determine whether calcitriol provides a therapeutic advantage to alfacalcidol. Methods: This was a randomized, active controlled study. Patients with intact parathyroid hormone (iPTH) >32 pmol/L were randomized to receive orally calcitriol or alfacalcidol after each haemodialysis for up to 24 weeks. Reduction of PTH, changes of plasma albumin‐corrected calcium and phosphorus were analysed. The initial dose of alfacalcidol was twice that of calcitriol. Results: Sixteen patients were randomized into each group. At baseline, plasma albumin‐corrected calcium, phosphorus and PTH were no different between groups. At 24 weeks, PTH changes were ?50.8 ± 31.8% and ?49.4 ± 32.5% from the baseline in the calcitriol and alfacalcidol groups, respectively (P = 0.91). The patients who achieved target PTH of 16–32 pmol/L were 82% in the calcitriol and 67% in the alfacalcidol group (P = 0.44). Plasma albumin‐corrected calcium and phosphorus were not significantly different but showed trends toward gradually increasing from baseline in both groups (calcium, 6.0 ± 7.2% vs 10.9 ± 6.5% (P = 0.10); phosphorus, 13.0 ± 29.4% vs 16.7 ± 57.2% (P = 0.83) in calcitriol and alfacalcidol, respectively). The mean dose of calcitriol and alfacalcidol were 4.1 and 6.9 µg/week, respectively (P < 0.0001). Conclusion: Alfacalcidol can be used to control secondary hyperparathyroidism at doses of 1.5–2.0 times that of calcitriol. The two drugs are equally efficacious and lead to similar changes in calcium and phosphorus.     

帕立骨化醇治疗维持性血液透析患者继发性甲状旁腺功能亢进的疗效观察

目的观察帕立骨化醇对维持性血液透析患者继发性甲状旁腺功能亢进症的治疗效果。方法选择2018年7月至2019年7月对非选择性维生素D受体激动剂(VDRA)疗效不佳或不能耐受拟钙剂或不愿手术治疗的继发性甲状旁腺功能亢进(SHPT)的维持性血液透析患者56例,根据血液全段甲状旁腺素(iPTH)水平将所有患者分为三个组别:A组(300 pg/mL≤iPTH<600 pg/mL)、B组(600 pg/mL≤iPTH<800 pg/mL)、C组(iPTH≥800 pg/mL)。根据体重给予不同剂量的静脉帕立骨化醇注射液,分别检测患者治疗前、初始使用1个月以及达到帕立骨化醇维持剂量时,iPTH、血钙、血磷、钙磷乘积的变化情况。结果患者骨痛、瘙痒、疲乏等症状明显改善。所有患者初始治疗1个月,iPTH达标率为51.8%(29/56),达到帕立骨化醇注射液维持治疗剂量百分比为57.1%(32/56)。患者初始治疗1个月与治疗前相比,iPTH水平显著下降[(718.76±457.56)pg/mL vs.(956.68±375.61)pg/mL,P<0.001],血钙、血磷以及钙磷乘积无明显改变[(2.28±0.23)mmol/L vs.(2.23±0.27)mmol/L,(2.15±0.49)mmol/L vs.(2.29±0.48)mmol/L,(58.49±17.71)mg^2/dl2 vs.(62.90±13.93)mg^2/dl2,P>0.05]。进入维持治疗阶段的患者,维持治疗与初始治疗相比,iPTH水平仍有下降趋势,但差异无统计学意义[(424.82±221.23)pg/mL vs.(517.55±325.77)pg/mL,P>0.05],血钙、血磷以及钙磷乘积比较差异无统计学意义[(2.33±0.20)mmol/L vs.(2.31±0.24)mmol/L,(2.13±0.44)mmol/L vs.(2.00±0.42)mmol/L,(61.24±12.25)mg^2/dl2 vs.(55.76±15.66)mg^2/dl2,P>0.05]。结论帕立骨化醇对非选择性VDRA疗效不佳或不能耐受拟钙剂或不愿手术治疗的维持性血液透析患者SHPT有较好的疗效,明显缓解患者骨痛、瘙痒、疲乏等症状,显著降低iPTH水平,且不增加高钙血症的发生风险。     

The oral 1-25 dihydroxyvitamin D3 pulse therapy in hemodialysis patients for the early treatment of secondary hyperparathyroidism]

It is said that maintenance hemodialysis patients are already suffering from secondary hyperparathyroidism (2HPT) from early stage of chronic renal failure. The treatment of 2HPT in this stage is very important for preventing renal osteodystrophy (ROD). But many long-term dialysis patients are still afflicted with ROD although vitamin D have been used for treatment. In this study, an oral administration of 1-25 (OH)2 D3 (4 micrograms) with pulse therapy twice a week at the day before hemodialysis was started for 12 weeks. The concentration of 1-25 (OH)2D3, total calcium (Ca), ionized calcium (Ca++), alkaline phosphatase (ALP) and parathyroid hormone (PHT) in serum were measured not only before and after every 2 hours of administration a day, but also for 12 weeks after that. The peak of serum 1-25 (OH)2D3 could be sufficiently elevated after 8 hours, and the slight peak of Ca++ could be seen after 8 hours as well. But the level of total calcium could not increased. Although the level of only HS-PTH has not increased after 24 hours, a significant reduction in serum level of C-PTH, intact-PTH and HS-PTH could be recognized after 12 weeks finally. This pulse therapy was effective in reducing the serum level of PTH in this early stage from beginning hemodialysis. But, it needs further studies for the standard treatment.     

Effect of aliskiren in chronic kidney disease patients with refractory hypertension undergoing hemodialysis: a randomized controlled multicenter study

Background

Applying a direct renin inhibitor (DRI) to advanced stage chronic kidney disease (CKD) patients is a matter of controversy. The purpose of this study was to evaluate the effect of the DRI, aliskiren, in patients with therapy-resistant hypertension undergoing hemodialysis (HD).

Methods

The study was a prospective, randomized multicenter trial exploring the antihypertensive effect of aliskiren in comparison with amlodipine, a calcium channel blocker, in patients undergoing HD. A total of 83 participants whose blood pressure (BP) had previously been treated with more than one antihypertensive agent and not having achieved the BP goal of <140/90 mmHg were randomly assigned to either aliskiren 150 mg or amlodipine 5 mg as an add-on therapy.

Results

A significant decrease in pre-dialysis clinic BP and home BP was found only in the amlodipine group and not in the aliskiren group. In contrast, there was a significant decrease in atrial natriuretic peptide (ANP) in the aliskiren group but not in the amlodipine group. N-terminal pro-B-type natriuretic hormone remained unchanged in both groups. Aliskiren significantly reduced angiotensin I and II, plasma renin activity, and increased plasma renin content. However, such changes were not observed in the amlodipine group.

Conclusion

Amlodipine, not aliskiren, effectively reduces BP in CKD patients with refractory hypertension undergoing HD. Aliskiren suppresses the renin?angiotensin system and reduces ANP. Whether the DRI is beneficial in improving cardiovascular events in patients undergoing HD remains to be elucidated in future studies.     

Calcitriol resistance in hemodialysis patients with secondary hyperparathyroidism

Nonselective vitamin D receptor activators (VDRA), such as calcitriol and alfacalcidol, have been successfully used in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis. Despite their beneficial effects on the control of serum PTH levels, their use has been limited by intolerance (development of hypercalcemia and hyperphosphatemia with consecutive cardiovascular toxicity). Apart from becoming intolerant, in 20–30 % of patients who use nonselective VDRA, serum PTH levels do not decrease appropriately despite increasing doses of these agents. These patients are considered calcitriol-resistant patients. Thus, calcitriol resistance and intolerance are two sides of the same coin: active vitamin D failure. Despite the clinical relevance of active vitamin D failure, definitions of resistance and intolerance are imprecise and have varied over time. More selective VDRA claim to produce less hypercalcemia and hyperphosphatemia and could help clinicians to overcome intolerance. Also, some studies have also shown that paricalcitol can be even useful in resistant patients. Significant limitations of iPTH as a reliable and useful clinical biomarker have been increasingly appreciated. There is evidence that intact PTH concentration must differ by 72 % between any two measurements before it can be considered a significant change. VDR polymorphisms could be involved in the development of SHPT in CKD patients. Interestingly, a higher incidence of the b allele of the VDR BsmI gene variant has been shown to be present in SHPT. The BsmI genotype can also affect the response of hemodialysis to IV calcitriol. A challenge for the future will be to establish biomarkers such as laboratory determinations or ultrasound findings that can help us to early identify those patients who will not respond appropriately to calcitriol or exhibit intolerable side effects .     

Intermittent versus maintenance iron therapy in children on hemodialysis: a randomized study

In patients with renal anemia, iron therapy can be administered intermittently or regularly at a low dose. We performed a randomized clinical trial in pediatric patients with end-stage renal failure on hemodialysis and absolute or functional iron deficiency. The study group received maintenance iron therapy according to the ferritin serum levels and the control group received intermittent 10-weekly doses. Success was defined as stabilization of ferritin levels between 100 and 800 g/l and transferrin saturation (TSAT) between 20% and 50%, in addition to an increase in the hemoglobin level. The major reason for exclusion was iron overload. The study group received 6 mg/kg per month of parenteral iron [95% confidence interval (CI) 3.3–8.8] and the control group 14.4 mg/kg per month (95% CI 12–16.8) (P<0.001). After 4 months of treatment, ferritin levels increased to 66 g/l (95% CI 69–200) in the study group and to 334 g/l (95% CI 145–522) in the control group (P=0.009). Maintenance therapy and intermittent weekly doses were successful in 73% and 38%, respectively. After 3 months of treatment, hemoglobin levels increased to 10 g/dl, with no difference between the groups. However, in the control group the increase in hemoglobin levels was unsustained, and 3 patients needed transfusion. Patients in the control group had a higher risk of iron overload than patients in the study group (70% vs. 19%). Thus, the regimen based on assessment of serum ferritin levels was more efficient than the intermittent regimen because it increased and maintained the hemoglobin levels with lower iron doses and a lower risk of iron overload.