Phase 3
N=151
A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
Hyperphosphatemia · End-Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01074125 ↗Enrolled (actual)
151
Serious AEs
14.6%
Results posted
Dec 2014
Primary outcome: Primary: Change in Serum Phosphorus From Baseline to End of Treatment — -0.10; -1.86; -2.13 mg/dL — p=<0.0001
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
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Phosphorus From Baseline to End of Treatment |
-0.10; -1.86; -2.13 | <0.0001 sig |
| SECONDARY Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment |
0.04; -1.94; -2.21 | — |
| SECONDARY Proportion of Patient With a Serum Phosphorus ≤5.5 mg/dL at the End of Treatment |
12.0; 51.0; 57.8 | — |
Summary
This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.
Eligibility Criteria
Inclusion Criteria
- Males or non-pregnant, non-lactating females
- Age > 18 years
- On thrice weekly hemodialysis or peritoneal dialysis for at least the previous three months prior to Screening Visit (Visit 0)
- Serum phosphorus levels ≥ 3.5 mg/dL and 6.0 mg/dL during the washout period (Visits 2 or 3)
- Taking 3 to 15 tablets/capsules per day of 667mg calcium acetate or 800 mg sevelamer (hydrochloride or carbonate), or any combination of these agents as reported by the patient at Screening Visit (Visit 0)
- Serum ferritin 10.0 mg/dL documented in all of the three monthly laboratories (done routinely in the dialysis unit) in the three months prior to the Screening Visit (Visit 0)
- History of multiple drug allergies or intolerances
- History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)
- Previous intolerance to oral ferric citrate
- 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
- Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
- Inability to tolerate oral drug intake
- Planned surgery or hospitalization during the trial (scheduled outpatient access surgery allowed)
- Any other medical condition that renders the patient unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the patient
- Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)
- Inability to cooperate with study personnel or history of noncompliance
- Unsuitable for this trial per Principal Investigator's clinical judgment
Data sourced from ClinicalTrials.gov (NCT01074125). 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.