N/A
N=22
Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
Hyperphosphatemia · End-stage Renal Disease · Renal Failure Chronic Requiring Hemodialysis
Bottom Line
View on ClinicalTrials.gov: NCT00967993 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: The Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period. — -1.53 mg/dL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ferric citrate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Keryx Biopharmaceuticals
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period. |
-1.53 | — |
| SECONDARY The Incidence of Treatment-emergent Adverse Events (New or Worsened From Study Drug Initiation) Will be Summarized by Body System, Severity, Type of Adverse Event, and Presumed Relationship to the Study Drug. |
— | — |
Summary
The objective of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a dietary phosphate binder in controlling and managing serum phosphorus levels in patients with end-stage renal disease (ESRD).
Eligibility Criteria
Inclusion Criteria
- Males and non-pregnant, non-lactating females
- Age > 18 years
- On thrice weekly hemodialysis for at least the previous three months prior to screening
- Serum phosphorus levels ≥ 2.5 mg/dL and 5.5 mg/dL at Study Drug Initiation Visit (Visit 3)
- Taking 3 to 18 tablets/capsules/day of calcium acetate calcium carbonate, lanthanum carbonate, sevelamer (hydrochloride or carbonate), or any combination of these agents as reported by the patient at screening
- Serum ferritin 10.0 mg/dL documented in 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
- History of malignancy in the last five years (treated cervical or skin cancer may be permitted if approved by Keryx)
- Previous intolerance to oral ferric citrate
- Absolute requirement for oral iron therapy
- Absolute requirement for Vitamin C (multivitamins [Centrum, 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 study (scheduled outpatient access surgery allowed)
- Any other medical condition that renders the patient unable to or unlikely to complete the study or that would interfere with optimal participation in the study or produce significant risk to the patient
- Receipt of any investigational drug within 30 days of randomization
- Inability to cooperate with study personnel or history of noncompliance
- Prior exposure to ferric citrate
- Patients with hemochromatosis or Thalassemia
Data sourced from ClinicalTrials.gov (NCT00967993). 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.