Phase 3
Completed N=233
KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD
Anemia of Chronic Kidney Disease
Source: ClinicalTrials.gov NCT02268994 ↗
Enrolled (actual)
233
Serious AEs
11.6%
Results posted
Feb 2018
Primary outcomePrimary: Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period — 61; 22 Participants
◆ Published Evidence
Emerging
5citations · ~5 / year
Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD).
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").
Linked Publications
-
Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period |
61; 22 | — |
| SECONDARY Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline |
0.39; -0.14 | — |
| SECONDARY Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline |
10.9; -1.3 | — |
| SECONDARY Mean Change in Ferritin at the End of 16 Weeks Minus Baseline |
68.1; -6.1 | — |
| SECONDARY Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb) |
57; 17 | — |
| SECONDARY Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline |
-0.28; -0.14 | — |
Eligibility Criteria
Inclusion Criteria
- Men and non-lactating women with negative serum pregnancy test (for women of child-bearing potential) at Screening
- Age ≥18 years
- CKD with Estimated Glomerular Filtration Rate (eGFR) X3 times upper limit of normal at Screening
- Symptomatic gastrointestinal bleeding or inflammatory bowel disease within 12 weeks prior to Screening
- Evidence of acute kidney injury or requirement for dialysis within 12 weeks prior to Screening
- Scheduled kidney transplant or initiation of dialysis planned within 24 weeks of Screening
- IV iron administered within 4 weeks prior to Screening
- Erythropoiesis-stimulating agent (ESA) administered within 4 weeks prior to Screening
- Blood transfusion within 4 weeks prior to Screening
- Receipt of any investigational drug within 4 weeks prior to Screening
- Cause of anemia other than iron deficiency or chronic kidney disease
- Malignancy (except non-melanoma skin cancer or disease-free for ≥2 years after curative therapy)
- History of hemochromatosis
- Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal marijuana) within the 12 months prior to Screening or evidence of such abuse (in the opinion of the PI)
- Subjects with known allergic reaction to previous oral iron therapy
- Previous intolerance to oral ferric citrate
- Psychiatric disorder that interferes with the subject's ability to comply with the study protocol
- Planned surgery or hospitalization (anticipated to last >72 hours) during the randomized period of the trial other than dialysis access related surgery.
- Any other medical condition that, in the opinion of the PI, renders 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
Data sourced from ClinicalTrials.gov (NCT02268994) and the linked publication. 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.