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A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease

Primary Purpose

Hyperphosphatemia, End-Stage Renal Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ferric citrate
Sponsored by
Keryx Biopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring Hyperphosphatemia, ESRD, Dialysis, End Stage Renal Disease, Phosphorus, Renal, Kidney

Eligibility Criteria

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

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 < 8.0 mg/dL at Screening Visit (Visit 0)
  • Serum phosphorus levels > 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 <1000micrograms/L and Transferrin Saturation (TSAT) <50% at the Screening Visit (Visit 0)
  • Willingness to be discontinued from current phosphate binder(s) and initiated on KRX-0502 (ferric citrate)
  • Willing and able to give informed consent
  • Willing and able to stay on a constant dose of Vitamin D (or its analogs) and Sensipar (cinacalcet) for the treatment period, if applicable.

Exclusion Criteria:

  • Parathyroidectomy within six months prior to Screening Visit (Visit 0)
  • Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
  • Serum phosphorus levels >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

Sites / Locations

  • Western Nephrology
  • Pines Clinical Research, Inc.
  • Kidney Care Associates, LLC
  • Circle Medical Management
  • Western New England Renal & Transplant Associates
  • Brookdale Physician's Dialysis Associates
  • DCI
  • Cleveland Clinical Foundation Fresenius East (Fairhill)
  • The Ohio State University Cramblett Medical Clinic
  • Southeast Renal Research Institute
  • Nephrology Associates, PC
  • Meharry Medical College Clinical Research Center
  • Vanderbilt University Medical Center Clinical Trials Center
  • Kidney Associates
  • Centre Point Dialysis
  • RCMI- Clinical Research Center Medical Sciences Campus University of Puerto Rico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1 g/day

6 g/day

8 g/day

Arm Description

1 g/day KRX-0502 (ferric citrate)

6 g/day KRX-0502 (ferric citrate)

8 g/day KRX-0502 (ferric citrate)

Outcomes

Primary Outcome Measures

Change in Serum Phosphorus From Baseline to End of Treatment
Mean change from baseline was calculated separately for each treatment arm (LOCF)

Secondary Outcome Measures

Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment
Mean change from baseline was calculated separately for each treatment arm. Only subjects that have both baseline and end of treatment serum phosphorus scores were analyzed for this outcome.
Proportion of Patient With a Serum Phosphorus ≤5.5 mg/dL at the End of Treatment
proportion was calculated separately for each treatment arm

Full Information

First Posted
February 17, 2010
Last Updated
December 3, 2014
Sponsor
Keryx Biopharmaceuticals
Collaborators
Collaborative Study Group (CSG)
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1. Study Identification

Unique Protocol Identification Number
NCT01074125
Brief Title
A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
Official Title
A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) Following a Two-Week Washout Period
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (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 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.
Detailed Description
There will be a screening visit about 4 weeks receiving study drug. Upon qualifying for the study after the screening visit, patients will then be asked to stop taking their current phosphate binder for about 2 weeks. Then, if patients continue to qualify for the study, they will be entered in the study that lasts about 28 days. Study visits will happen every week during the patient's usual dialysis appointments. There will be a total of up to 9 visits for this study, and total participation time could last up to 8 weeks.

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
Hyperphosphatemia, ESRD, Dialysis, End Stage Renal Disease, Phosphorus, Renal, Kidney

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 g/day
Arm Type
Experimental
Arm Description
1 g/day KRX-0502 (ferric citrate)
Arm Title
6 g/day
Arm Type
Experimental
Arm Description
6 g/day KRX-0502 (ferric citrate)
Arm Title
8 g/day
Arm Type
Experimental
Arm Description
8 g/day KRX-0502 (ferric citrate)
Intervention Type
Drug
Intervention Name(s)
ferric citrate
Other Intervention Name(s)
KRX-0502
Intervention Description
1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
Primary Outcome Measure Information:
Title
Change in Serum Phosphorus From Baseline to End of Treatment
Description
Mean change from baseline was calculated separately for each treatment arm (LOCF)
Time Frame
Baseline and day 28
Secondary Outcome Measure Information:
Title
Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment
Description
Mean change from baseline was calculated separately for each treatment arm. Only subjects that have both baseline and end of treatment serum phosphorus scores were analyzed for this outcome.
Time Frame
Baseline and day 28
Title
Proportion of Patient With a Serum Phosphorus ≤5.5 mg/dL at the End of Treatment
Description
proportion was calculated separately for each treatment arm
Time Frame
Baseline and day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 < 8.0 mg/dL at Screening Visit (Visit 0) Serum phosphorus levels > 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 <1000micrograms/L and Transferrin Saturation (TSAT) <50% at the Screening Visit (Visit 0) Willingness to be discontinued from current phosphate binder(s) and initiated on KRX-0502 (ferric citrate) Willing and able to give informed consent Willing and able to stay on a constant dose of Vitamin D (or its analogs) and Sensipar (cinacalcet) for the treatment period, if applicable. Exclusion Criteria: Parathyroidectomy within six months prior to Screening Visit (Visit 0) Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease Serum phosphorus levels >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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia B Lewis, MD
Organizational Affiliation
Collaborative Study Group (CSG)
Official's Role
Study Chair
Facility Information:
Facility Name
Western Nephrology
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80031
Country
United States
Facility Name
Pines Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Kidney Care Associates, LLC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Circle Medical Management
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Western New England Renal & Transplant Associates
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Brookdale Physician's Dialysis Associates
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
DCI
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
Cleveland Clinical Foundation Fresenius East (Fairhill)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44104
Country
United States
Facility Name
The Ohio State University Cramblett Medical Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Southeast Renal Research Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Nephrology Associates, PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Meharry Medical College Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
Vanderbilt University Medical Center Clinical Trials Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-1371
Country
United States
Facility Name
Kidney Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Centre Point Dialysis
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53214
Country
United States
Facility Name
RCMI- Clinical Research Center Medical Sciences Campus University of Puerto Rico
City
Rio Piedras
ZIP/Postal Code
00936-5067
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
23369827
Citation
Dwyer JP, Sika M, Schulman G, Chang IJ, Anger M, Smith M, Kaplan M, Zeig S, Koury MJ, Blumenthal SS, Lewis JB; Collaborative Study Group. Dose-response and efficacy of ferric citrate to treat hyperphosphatemia in hemodialysis patients: a short-term randomized trial. Am J Kidney Dis. 2013 May;61(5):759-66. doi: 10.1053/j.ajkd.2012.11.041. Epub 2013 Jan 29.
Results Reference
derived

Learn more about this trial

A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease

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