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A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients

NCT01324128 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1059

Last updated 2014-04-24

Study results available
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Summary

This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.

Conditions

  • Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

DRUG

PA21 (2.5 g tablet containing 500 mg iron)

Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).

DRUG

Sevelamer carbonate

Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)

DRUG

PA21-1 (1.25 g tablet containing 250 mg iron)

Low dose comparator (1.25 g/day)

Sponsors & Collaborators

  • Fresenius Medical Care North America

    collaborator INDUSTRY

  • Vifor Pharma

    lead INDUSTRY

Principal Investigators

  • Juergen Floege, MD · Medizinische Klinik II

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-04-30
Completion
2012-10-31

Countries

  • United States
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Germany
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Africa
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT01324128 on ClinicalTrials.gov