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PA21 Safety and Efficacy in Adult Chinese Subjects

NCT03644264 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2021-06-02

No results posted yet for this study

Summary

This study evaluates the efficacy of PA21 in comparison with sevelamer carbonate (Renvela®) in lowering and maintaining serum phosphorus in adult Chinese subjects with CKD on dialysis after 12 weeks of treatment.

Conditions

  • Chronic Kidney Disease Requiring Chronic Dialysis
  • Hyperphosphatemia

Interventions

DRUG

PA21

sucroferric oxyhydroxide is a mixture of polynuclear iron(III)-oxyhydroxide (about 33% m/m), sucrose (about 30% m/m), and starches (about 28% m/m) and contains ≤10% m/m water.

DRUG

sevelamer carbonate

sevelamer carbonate tablets containing 800 mg of sevelamer carbonate.

Sponsors & Collaborators

  • Vifor Fresenius Medical Care Renal Pharma

    lead INDUSTRY

Principal Investigators

  • Hou Fanfan, MD · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2020-08-21
Completion
2020-08-21

Countries

  • China

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 NCT03644264 on ClinicalTrials.gov