Trials / Completed
CompletedNCT02128074
A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia
A Phase 2 Pilot Study of KRX-0502 (Ferric Citrate) in Treating Iron-deficiency Anemia in Patients With Stage 3-5 Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Keryx Biopharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to evaluate the efficacy and safety of KRX-0502, administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD).
Detailed description
Previous clinical trials have tested KRX-0502 administered with food, in dialysis-dependent and NDD-CKD patients. This clinical trial will evaluate the safety and efficacy of KRX-0502 in treating iron deficiency anemia in anemic, stage III to V NDD-CKD patients in a new dosing regimen (without food).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KRX-0502 | 1g tablets of KRX-0502 |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2014-11-01
- Completion
- 2014-11-01
- First posted
- 2014-05-01
- Last updated
- 2018-08-24
- Results posted
- 2018-08-24
Locations
3 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT02128074. Inclusion in this directory is not an endorsement.