Phase 3
N=168
A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis
End Stage Renal Disease · Kidney Failure · Renal Failure · Hyperphosphatemia · ESRD
Bottom Line
View on ClinicalTrials.gov: NCT01554982 ↗Enrolled (actual)
168
Serious AEs
45.2%
Results posted
Jul 2016
Primary outcome: Primary: Safety Parameters — 142; 35; 75; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ferric citrate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Keryx Biopharmaceuticals
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Parameters |
142; 35; 75; 0; 10 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Males or non-pregnant, non-breast-feeding females who participated in the Safety Assessment Period (SAP), and if eligible, the Efficacy Assessment Period (EAP) of Study KRX-0502-304
- Willing and able to give informed consent
Exclusion Criteria
- Subjects on KRX-0502 (ferric citrate) in KRX-0502-304 who were treatment failures in first period
- Any subject in Study KRX-0502-304 SAP who early terminated from the trial
- Any subject who participated in Study KRX-0502-304 but declined EAP
- Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
- History of malignancy in the last five years
- Previous intolerance to KRX-0502 (ferric citrate)
- Intolerance to oral iron-containing products
- Absolute requirement for oral iron therapy
- Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.] allowed)
- Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
- Inability to tolerate oral drug intake
- Any other medical condition that rendered the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
- Inability to cooperate with study personnel or history of noncompliance
- Unsuitable for this trial per Principal Investigator's (PI) clinical judgment.
Data sourced from ClinicalTrials.gov (NCT01554982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.