A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
This study has been completed.
Sponsor:
Keryx Biopharmaceuticals
Collaborator:
Collaborative Study Group (CSG)
Information provided by (Responsible Party):
Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00648167
First received: March 27, 2008
Last updated: September 7, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to evaluate the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease. These patients will be switched to Zerenex™ from their current high dose of phosphate binder and, based on their serum phosphorus levels, will be titrated up from 3.4g/day of Zerenex™ to maximum tolerated and safe doses of Zerenex™. Doses will be adjusted weekly, based on serum phosphorus levels, with the maximum dose administered being approximately 12g/day.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperphosphatemia End-stage Renal Disease |
Drug: ferric citrate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Safety and Tolerability Study of Zerenex (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:
- This study is exploratory in nature and is intended to assess the tolerability and safety of Zerenex. [ Time Frame: 4-10 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Serum phosphorus levels will be monitored prior to study drug titration. [ Time Frame: 4-10 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 55 |
| Study Start Date: | March 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: I
All patients will be switched from their current phosphate binder to Zerenex, and titrated to the maximum tolerated dose (up to about 12g/day) based on their serum phosphorus levels.
|
Drug: ferric citrate
Zerenex will be provided as a 375mg capsule. Dosing and frequency are dependent on patient's serum phosphorus levels. Dosing will occur over the 28-day study.
|
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and non-pregnant, nonlactating females
- Age > 18 years
- On thrice weekly hemodialysis for at least the previous 3 months prior to randomization
- Phosphorous levels ≥3.5mg/dL at Screening Visit
- On at least 12 tablets/capsules/day of calcium acetate (667mg), calcium carbonate (500mg), lanthanum carbonate (500mg), sevelamer hydrochloride (800mg or two 400mg tablets), or any combination of these agents
- Serum ferritin <1000micrograms/L and TSAT <50%
- Willing to be discontinued from current phosphate binder(s) and initiated on Zerenex
- Willing and able to give informed consent
Exclusion Criteria:
- Parathyroidectomy within 6 months prior to Screening
- Actively symptomatic GI disease such as peptic ulcer disease, gastro esophageal reflux, diverticulosis, irritable bowel syndrome (treated asymptomatic is permitted)
- History of documented inflammatory bowel disease or erosive esophagitis
- Serum Phosphorus levels >10.0 mg/dL documented in the 3 monthly laboratories (done routinely in the dialysis unit) in the 3 months prior to the Screening Visit
- History of multiple drug allergies
- History of malignancy in the last 5 years (treated cervical or 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 [Neprocaps, 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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Keryx Biopharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00648167 History of Changes |
| Other Study ID Numbers: | KRX-0502-201 |
| Study First Received: | March 27, 2008 |
| Last Updated: | September 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Keryx Biopharmaceuticals:
|
ESRD end-stage renal disease end stage renal disease hemodialysis dialysis kidney failure |
renal failure kidney renal phosphate binder phosphorus |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Hyperphosphatemia Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Phosphorus Metabolism Disorders Metabolic Diseases |
Citric Acid Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013