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Study of Phosphate Levels in Patients With Chronic Kidney Disease

NCT00824460 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2014-04-01

Study results available
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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

Interventions

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).

Sponsors & Collaborators

  • Vifor Pharma

    lead INDUSTRY

Principal Investigators

  • Prof. Rudolf P Wutrich, MD · Unafilliated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-10-31
Completion
2010-03-31

Countries

  • United States
  • Bulgaria
  • Croatia
  • Czechia
  • Germany
  • Poland
  • Romania
  • Russia
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00824460 on ClinicalTrials.gov