Phase 2
Completed N=149
Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis
Source: ClinicalTrials.gov NCT01736397 ↗Enrolled (actual)
149
Serious AEs
10.1%
Results posted
Oct 2017
Primary outcomePrimary: Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment — 21.6; 21.0; 31.7; 20.0 % saturation
Summary
The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of treatment is approximately 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment |
21.6; 21.0; 31.7; 20.0 | — |
| PRIMARY Change in Serum Phosphorus Levels From Baseline to End of Treatment |
4.5; 4.7; 3.9; 4.4 | — |
| SECONDARY Change in Ferritin Levels From Baseline to End of Treatment |
115.8; 110.0; 189.4; 105.6 | — |
| SECONDARY Change in Hemoglobin Levels From Baseline to End of Treatment |
10.5; 10.6; 11.0; 10.4 | — |
Eligibility Criteria
Inclusion Criteria
- Stage III to V Chronic Kidney Disease
- Serum Phosphorus 4.0-6.0 mg/dL prior to Randomization
- Ferritin 300 ng/mL or less
- Transferrin Saturation (TSAT) 30% or less
- Hemoglobin >9.0 and <12.0 g/dL
- Must consume a minimum of 2 meals per day
Exclusion Criteria
- Parathyroidectomy within 24 weeks of study
- gastrointestinal bleed or inflammatory bowel disease within 12 weeks of study
- Requirement for dialysis or kidney injury within 8 weeks of study
- Absolute requirement for oral iron, intravenous iron, Erythropoiesis-Stimulating Agent, blood transfusions, and Sensipar during the study
- Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
- Absolute requirement for vitamin C, niacin, or nicotinamide outside of multivitamins
- History of hemochromatosis
- Allergy to iron products
- History of malignancy in last 5 years
Data sourced from ClinicalTrials.gov (NCT01736397). 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. Informational only — not medical advice.