NCT00824460

Study of Phosphate Levels in Patients With Chronic Kidney Disease

An Open-label, Randomised, Active Controlled Multi-center Phase II Dose Finding Study to Evaluate the Ability of PA21 to Lower Serum Phosphate Levels and the Tolerability in Patients With Chronic Kidney Disease on Maintenance Hemodialysis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Vifor Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the ability of different doses of PA21 to lower serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	1.25 g PA21 (250 mg iron)	Daily dose of 1.25 g PA21 (1 tablet/day) for 6 weeks. One PA21 tablet will be taken orally with the largest meal of the day.
DRUG	5.0 g PA21 (1,000 mg iron)	Daily dose of 5.0 g PA21 (4 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with the largest meal of the day, and one PA21 tablet will be taken orally with each of the two smaller main meals of the day (3 meals per day).
DRUG	7.5 g PA21 (1,500 mg iron)	Daily dose of 7.5 g PA21 (6 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with each of the three main meals of the day (3 meals per day).
DRUG	10.0 g PA21 (2,000 mg iron)	Daily dose of 10.0 g PA21 (8 tablets/day) for 6 weeks. Four PA21 tablets will be taken orally with the largest meal of the day, and two PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
DRUG	12.5 g PA21 (2,500 mg iron)	Daily dose of 12.5 g PA21 (10 tablets/day) for 6 weeks. Four tablets will be taken orally with the largest meal of the day, and three PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
DRUG	Sevelamer hydrochloride	Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets/day) for 6 weeks. Two Sevelamer tablets will be taken orally with each of the three main meals of the day (3 meals per day).

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-10-01
• Completion: 2010-03-01
• First posted: 2009-01-16
• Last updated: 2014-04-01
• Results posted: 2014-04-01

Locations

60 sites across 9 countries: United States, Bulgaria, Croatia, Czechia, Germany, Poland, Romania, Russia, Switzerland