PA21 safety and efficacy

• Research type

  Research Study

• Full title

  An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 Compared with Sevelamer Carbonate Followed by a Randomised Comparison of PA21-Maintenance Dose Versus PA21-Low Dose in Dialysis Patients with Hyperphosphataemia

• IRAS ID

  66003

• Contact name

  Paul Warwicker

• Sponsor organisation

  Vifor (International) Inc.

• Eudract number

  2010-022011-19

• ISRCTN Number

  N/A

• Research summary

  This is a phase III open-label study in patients with hyperphosphataemia, a common and serious complication in patients with chronic kidney disease, particularly those requiring dialysis. The study is designed to evaluate safety and efficacy of PA21, a novel phosphate binder medicine. The study consists of 2 stages. The first stage is a 24 week study where the safety and efficacy of PA21 will be compared to sevelamer carbonate (Renvela©), a common treatment for hyperphosphataemia. Patients who receive peritoneal dialysis and haemodialysis will participate in the first stage. Starting doses of PA21 and Renvela© may be adjusted for efficacy and tolerability reasons. At the end of the first 24 weeks stage, a subgroup of patients on haemodialysis will be selected from the PA21 group and participate in the second stage. During the second stage 50% of patients will continue taking PA21 at the dose they were receiving at Week 24 (maintenance dose group) and 50% of patients will switch to 1.25 g/day PA21 (low dose group) for 3 weeks. All the tests performed during the study will be normal clinical procedures (assessment of blood chemistry and haematology, vital signs, electrocardiography).At the end of the second part of the study (Week 27), subjects from the PA21 maintenance dose treatment group will have a chance to participate in a 6 month extension study (PA-CL-05B), covered by a separate Study Protocol.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/98

• Date of REC Opinion

  21 Feb 2011

• REC opinion

  Further Information Favourable Opinion