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A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)

Primary Purpose

Hyperphosphatemia, End-stage Renal Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ferric citrate

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring ESRD, end-stage renal disease, end stage renal disease, hemodialysis, dialysis, kidney failure, renal failure, kidney, renal, phosphate binder, phosphorus

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Transferrin Saturation (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

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KRX-0502 (ferric citrate)

Arm Description

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.

Outcomes

Primary Outcome Measures

The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28)

Secondary Outcome Measures

Full Information

NCT ID

NCT00648167

First Posted

March 27, 2008

Last Updated

March 3, 2017

Sponsor

Keryx Biopharmaceuticals

Collaborators

Collaborative Study Group (CSG)

1. Study Identification

Unique Protocol Identification Number

NCT00648167

Brief Title

A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)

Official Title

A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Keryx Biopharmaceuticals

Collaborators

Collaborative Study Group (CSG)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperphosphatemia, End-stage Renal Disease

Keywords

ESRD, end-stage renal disease, end stage renal disease, hemodialysis, dialysis, kidney failure, renal failure, kidney, renal, phosphate binder, phosphorus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KRX-0502 (ferric citrate)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

ferric citrate

Other Intervention Name(s)

KRX-0502

Intervention Description

ferric citrate 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.

Primary Outcome Measure Information:

Title

The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28)

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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 Transferrin Saturation (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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julia B Lewis, MD

Organizational Affiliation

Collaborative Study Group at the Nephrology Clinical Trials Center, Vanderbilt University Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.keryx.com

Description

Sponsor

Learn more about this trial

A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)

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