CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 154 enrolled
Drug / intervention
1.25 g PA21 (250 mg iron) +5 moredrug
Likely dose
1.25 g PA21 (250 mg iron)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00824460
NCT00824460Phase 2Completed
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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

Vifor Pharma·interventional·Posted Jan 16, 2009·Updated Apr 1, 2014

In Brief

A Phase 2 clinical trial evaluating 1.25 g PA21 (250 mg iron), 5.0 g PA21 (1,000 mg iron), and 4 other interventions for Chronic Kidney Disease. Completed, enrolled 154 participants across 60 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease
CountriesBulgaria, Croatia, Czechia, Germany, Poland, Romania, Russia, Switzerland, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 16, 2009
Enrollment StartDec 1, 2008
Primary CompletionOct 1, 2009
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.5 years ago

Interventions

1.25 g PA21 (250 mg iron)drug

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.

5.0 g PA21 (1,000 mg iron)drug

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).

7.5 g PA21 (1,500 mg iron)drug

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).

10.0 g PA21 (2,000 mg iron)drug

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).

12.5 g PA21 (2,500 mg iron)drug

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).

Sevelamer hydrochloridedrug

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).