MedTrace Logo

KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD

NCT02268994 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2018-03-22

Study results available
· View outcomes & findings →

Summary

a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period").

Conditions

  • Anemia of Chronic Kidney Disease

Interventions

DRUG

ferric citrate

1 g ferric citrate containing approximately 210 mg of ferric iron

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • Keryx Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Geoffrey Block, MD · Denver Nephrology

  • Glenn Chertow, MD · Division of Nephrology at Stanford University School of Medicine

  • Steven Fishbane, MD · Kidney Disease and Hypertension at North Shore University Hospital/Long Island Jewish Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02268994 on ClinicalTrials.gov