PA21 long-term safety extension study

• Research type

  Research Study

• Full title

  An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Phase 3 Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21 Compared with Sevelamer Carbonate in Dialysis Patients with Hyperphosphataemia. Extension Study for Protocol PA-CL-05A.

• IRAS ID

  66662

• Contact name

  Paul Warwicker

• Sponsor organisation

  Vifor (International) Inc.

• Eudract number

  2010-022012-40

• ISRCTN Number

  N/A

• Research summary

  This is an open-label extension study of the protocol PA-CL-05A in chronic kidney disease patients with hyperphosphataemia. Patients who have completed treatment in phase III Study PA-CL-05A (Stage 1 or Stage 2, except patients who participated in the PA21 low dose group), will be enrolled into this extension study. Patients will sign informed consent form, and will continue to receive either PA21 or sevelamer carbonate at the same dose as given at Week 24 during the PA-CL-05A study. Treatment will continue for further 28 weeks. Study visits to the clinic will be conducted every 4 weeks. For patients on haemodialysis, visits will be planned to coincide with the first dialysis session of the week. For patients on peritoneal dialysis, visits will be planned to coincide with the weekday for visits used in protocol PA-CL-05A (1 day). All the tests performed during the study will be normal clinical procedures (assessment of blood chemistry and haematology, vital signs, electrocardiography). Patients will complete the study at Visit 8 after 28 weeks of treatment. All patients, whether completing the study or withdrawn prematurely, will be followed up 14 days after their last study visit to collect any new AEs and concomitant medication.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/99

• Date of REC Opinion

  21 Feb 2011

• REC opinion

  Further Information Favourable Opinion