MedTrace Logo

A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients

NCT01464190 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 659

Last updated 2014-04-01

Study results available
· View outcomes & findings →

Summary

This is a Phase 3, randomised, active controlled, multicentre extension study to investigate the long-term safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. This is an extension study to PA-CL-05A (NCT01324128), subjects have already been enrolled and have been treated with study medication for at least 24 weeks.

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

Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/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
2011-09-30
Primary Completion
2012-10-31
Completion
2013-04-30

Countries

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

Study Locations

More Related Trials

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 NCT01464190 on ClinicalTrials.gov