Randomized controlled trial to compare the efficacy and safety of oral paricalcitol with oral calcitriol in dialysis patients with secondary hyperparathyroidism.

AIM: The objective of the study was to compare the efficacy and safety of oral paricalcitol with oral calcitriol for treating secondary hyperparathyroidism. METHODS: We conducted the first multicenter open-labelled parallel group randomized controlled trial in 66 patients on dialysis. Patients were randomized to paricalcitol or calcitriol at a 3:1 dose ratio and adjusted to maintain intact parathyroid hormone (iPTH) level between 150-300 pg/mL, serum calcium ≤2.74 mmol/L and calcium-phosphate product ≤5.63 mmol(2) /L(2). The primary end point was the proportion of patients who achieved >30% reduction in iPTH. RESULTS: At 24 weeks, 22 (61.1%) patients in the paricalcitol and 22 (73.3%) in the calcitriol group had achieved the primary end-point (P-value = 0.29). The cumulative proportion of patients who achieved the end-point at 6 weeks, 12 weeks and 24 weeks were 50%, 80.6% and 86.1%, respectively, in paricalcitol and 53.3%, 86.7% and 86.7%, respectively, in the calcitriol group (P-value = 0.67). Median time to the end-point was 6 weeks in both groups. There were no significant differences in iPTH level at any time during the study. The median reduction in iPTH at 24 weeks was 48.4% in the paricalcitol group and 41.9% in the calcitriol group (P-value = 0.6). The median maximal iPTH reduction was 77.1% (paricalcitol) and 83.7% (calcitriol), P-value = 0.3. Serum calcium and incidence of hypercalcaemia did not differ between groups. 16.7% of patients in both groups had at least one episode of hypercalcaemia (serum calcium >2.74 mmol/L). Other adverse events were similar between groups. CONCLUSION: Our study suggests that oral paricalcitol has similar efficacy and safety to oral calcitriol.

Effects of Sustained-Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results.

TRK-100STP, a sustained-release preparation of the orally active prostacyclin analogue beraprost sodium, targets renal hypoxia. This study aimed to show the superiority of TRK-100STP over placebos in patients with chronic kidney disease (with either primary glomerular disease or nephrosclerosis) to determine the recommended dose. CASSIOPEIR (Chronic Renal Failure Asian Study with Oral PGI2 Derivative for Evaluating Improvement of Renal Function) was a randomized, double-blind, placebo-controlled study conducted at 160 sites in seven Asia-Pacific countries and regions. Eligible patients (n = 892) were randomized to TRK-100STP 120, 240 µg, or placebo for a treatment period of up to 4 years. The primary efficacy endpoint was time to first occurrence of a renal composite: doubling of serum creatinine or occurrence of end-stage renal disease. No significant differences were observed in composite endpoints between TRK-100STP and placebo (P = 0.5674). Hazard ratios (95% CI) in the TRK-100STP 120 and 240 µg vs. placebo groups were 0.98 (0.78, 1.22) and 0.91 (0.72, 1.14), respectively. The overall incidence of adverse events and adverse drug reactions was comparable between treatment arms.

Time and exercise improve phosphate removal in hemodialysis patients.

BACKGROUND: Control of serum phosphate remains a difficult clinical issue in most hemodialysis (HD) patients. This study examines 2 nonpharmacological approaches to improving phosphate control in HD patients. METHODS: First, 9 stable HD patients underwent dialysis in random fashion for either 4 hours 3 times weekly or 5 hours 3 times weekly. Adjustments were made to blood flow rates such that Kt/V was the same for all sessions, thus allowing independent assessment of the influence of time. The primary end point was weekly dialysate phosphate removal. In the second study, 12 different patients underwent an exercise program in which they pedaled a bicycle ergometer either immediately before or during dialysis. Again, weekly dialysate phosphate removal was measured. RESULTS: In the time study, urea reduction ratio (69% +/- 0.02% versus 68% +/- 0.07, 4 versus 5 hours) and weekly urea removal were no different between the 2 groups. However, weekly phosphate removal (3,007 +/- 641 versus 3,400 +/- 647 mg; P < 0.02) significantly improved with longer dialysis duration. Serum phosphate levels improved, but did not reach statistical significance in this short-term study. In the exercise study, weekly phosphate removal improved with exercise, but did not reach significance (2,741 +/- 715 [no exercise] versus 2,917 +/- 833 [exercise predialysis] versus 2,992 +/- 852 mg [exercise during dialysis]; P = 0.055), although comparing only exercise during dialysis with no exercise reached significance (P = 0.02). There was no significant difference in serum phosphate levels. CONCLUSION: Both increased dialysis time and exercise result in increased dialytic removal of phosphate and could be expected in the long term to improve phosphate control.