Conditions: Chronic Kidney Disease
Keywords: Hemodialysis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 154
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

Interventions: intervention 1: 1.25 g PA21 (250 mg iron) intervention 2: 5.0 g PA21 (1,000 mg iron) intervention 3: 7.5 g PA21 (1,500 mg iron) intervention 4: 10.0 g PA21 (2,000 mg iron) intervention 5: 12.5 g PA21 (2,500 mg iron) intervention 6: Sevelamer hydrochloride
Intervention descriptions: intervention 1: 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. intervention 2: 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). intervention 3: 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). intervention 4: 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). intervention 5: 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). intervention 6: 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).

Protocol document: