A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis
NCT01554982 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168
Last updated 2016-07-13
Summary
A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may participate in this trial.
Conditions
- End Stage Renal Disease
- Kidney Failure
- Renal Failure
- Hyperphosphatemia
- ESRD
Interventions
- DRUG
-
ferric citrate
Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Sponsors & Collaborators
-
Keryx Biopharmaceuticals
lead INDUSTRY
Principal Investigators
-
Julia B Lewis, MD · Collaborative Study Group
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-08-31
- Primary Completion
- 2014-06-30
- Completion
- 2014-08-31
Countries
- United States
- Puerto Rico
Study Locations
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