Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
This study has been completed.
Sponsor:
Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00967993
First Posted: August 28, 2009
Last Update Posted: December 5, 2014
Information provided by (Responsible Party):
Keryx Biopharmaceuticals
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Hyperphosphatemia End-stage Renal Disease Renal Failure Chronic Requiring Hemodialysis | Drug: ferric citrate | Phase 2 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | A 6-Week Feasibility Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) |
Resource links provided by NLM:
Further study details as provided by Keryx Biopharmaceuticals:
Primary Outcome Measures:
- 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. [ Time Frame: 4 weeks ]
Secondary Outcome Measures:
- 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. [ Time Frame: 6 weeks ]
| Enrollment: | 22 |
| Study Start Date: | January 2010 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
KRX-0502 (ferric citrate)
KRX-0502 will be supplied as one caplet of ferric citrate containing 210 mg of ferric iron as ferric citrate. All patients initiated on study drug will start with a fixed dose of KRX-0502 (ferric citrate) of 6 caplets per day. Patients will be titrated at Visits 4, 5, and 6 based on serum phosphorus lab results. If serum phosphorus levels go below normal, there will be a decrease in pills; if serum phosphorus levels go above normal, there wil be an increase in pills. The maximum number of KRX-0502 (ferric citrate) caplets per day will be 12, or 12 g/day of ferric citrate. Patients will take study drug orally with meals or snacks or within one hour after their meals or snacks. |
Drug: ferric citrate
KRX-0502 will be supplied as one caplet of ferric citrate containing 210 mg of ferric iron as ferric citrate
Other Name: KRX-0502
|
Detailed Description:
This is a multi-center, non-blinded, efficacy and tolerability trial in patients with ESRD on dialysis three times per week. Approximately 24 patients (approximately twelve diabetic patients and approximately twelve non-diabetic patients) in Israel will be initiated on KRX-0502 (ferric citrate). The study will consist of a two-week washout period immediately followed by a six-week treatment period in. Patients will be initiated on study drug over two to three weeks.
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients selected from pool of dialysis patients at each clinic.
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 < 8.5 mg/dL at Screening Visit (Visit 0)
- Serum phosphorus levels > 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 <1000micrograms/L and Transferrin Saturation (TSAT) <50%
- Willing to be discontinued from current phosphate binder(s) and initiated on KRX-0502 (ferric citrate)
- Willing and able to give informed consent
Exclusion Criteria:
- Parathyroidectomy within six months prior to Screening Visit (Visit 0)
- Actively symptomatic gastrointestinal bleeding and inflammatory bowel disease
- Serum phosphorus levels >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
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967993
Locations
| Israel | |
| Barzilai Medical Center Ben-Gurion University | |
| Ashkelon, Israel, 78306 | |
| Hadassah University Hospital-Ein Kerem | |
| Jerusalem, Israel, 91120 | |
| Assaf Haraofeh Medical Center | |
| Zerifin, Israel, 70300 | |
Sponsors and Collaborators
Keryx Biopharmaceuticals
Investigators
| Principal Investigator: | Itamar Raz, MD | Hadassah University Hospital-Ein Kerem |
More Information
Additional Information:
Publications:
| Responsible Party: | Keryx Biopharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00967993 History of Changes |
| Other Study ID Numbers: |
KRX-0502-202 |
| First Submitted: | August 27, 2009 |
| First Posted: | August 28, 2009 |
| Results First Submitted: | October 4, 2014 |
| Results First Posted: | November 18, 2014 |
| Last Update Posted: | December 5, 2014 |
| Last Verified: | November 2014 |
Keywords provided by Keryx Biopharmaceuticals:
|
hyperphosphatemia end-stage renal disease ESRD |
hemodialysis diabetes dialysis |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Renal Insufficiency Hyperphosphatemia Urologic Diseases Phosphorus Metabolism Disorders Metabolic Diseases |
Citric Acid Ferric Compounds Anticoagulants Calcium Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Hematinics |