Back to resultsFerric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis
Primary Purpose
Iron Deficiency, Iron Deficiency Anemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ferric Citrate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency focused on measuring CKD, Chronic Kidney Disease, Phosphorus, Iron Deficiency, Iron Deficiency Anemia, Elevated Phosphorus
Eligibility Criteria
Inclusion Criteria:
- Stage III to V Chronic Kidney Disease
- Serum Phosphorus 4.0-6.0 mg/dL prior to Randomization
- Ferritin 300 ng/mL or less
- Transferrin Saturation (TSAT) 30% or less
- Hemoglobin >9.0 and <12.0 g/dL
- Must consume a minimum of 2 meals per day
Exclusion Criteria:
- Parathyroidectomy within 24 weeks of study
- gastrointestinal bleed or inflammatory bowel disease within 12 weeks of study
- Requirement for dialysis or kidney injury within 8 weeks of study
- Absolute requirement for oral iron, intravenous iron, Erythropoiesis-Stimulating Agent, blood transfusions, and Sensipar during the study
- Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
- Absolute requirement for vitamin C, niacin, or nicotinamide outside of multivitamins
- History of hemochromatosis
- Allergy to iron products
- History of malignancy in last 5 years
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ferric Citrate
Placebo
Arm Description
Ferric citrate will be taken with or within one hour of meals or snacks. The starting dose of ferric citrate is 3 tablets/day and titrated by the subject's serum phosphorus results at each treatment visit.
Placebo will be taken with or within one hour of meals or snacks. The starting dose of placebo is 3 tablets per day and titrated by the subject's serum phosphorus results at each treatment visit.
Outcomes
Primary Outcome Measures
Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment
The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement.
Change in Serum Phosphorus Levels From Baseline to End of Treatment
The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement.
Secondary Outcome Measures
Change in Ferritin Levels From Baseline to End of Treatment
The difference in ferritin levels between the value at the end of treatment (week 12) minus the baseline measurement.
Change in Hemoglobin Levels From Baseline to End of Treatment
The difference in hemoglobin levels between the value at the end of treatment (week 12) minus the baseline measurement.
Full Information
NCT ID
NCT01736397
First Posted
November 16, 2012
Last Updated
September 20, 2017
Sponsor
Keryx Biopharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01736397
Brief Title
Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis
Official Title
A Phase 2 Study of KRX-0502 (Ferric Citrate) in Managing Serum Phosphorus and Iron Deficiency in Anemic Subjects With Stage III to V Chronic Kidney Disease Not on Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keryx Biopharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of treatment is approximately 12 weeks.
Detailed Description
This is a randomized, double-blind, placebo-controlled, three-period, multi-center clinical trial. Following a Screening and Qualification Period and a two-week Washout Period (for those subjects entering the study on a phosphate binder), eligible subjects will be randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or placebo for up to approximately 12 weeks. The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic CKD subjects not on dialysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Iron Deficiency Anemia
Keywords
CKD, Chronic Kidney Disease, Phosphorus, Iron Deficiency, Iron Deficiency Anemia, Elevated Phosphorus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferric Citrate
Arm Type
Experimental
Arm Description
Ferric citrate will be taken with or within one hour of meals or snacks. The starting dose of ferric citrate is 3 tablets/day and titrated by the subject's serum phosphorus results at each treatment visit.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be taken with or within one hour of meals or snacks. The starting dose of placebo is 3 tablets per day and titrated by the subject's serum phosphorus results at each treatment visit.
Intervention Type
Drug
Intervention Name(s)
Ferric Citrate
Other Intervention Name(s)
KRX-0502
Intervention Description
Dose depends on serum phosphorus levels collected at each study visit.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment
Description
The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement.
Time Frame
12 Weeks
Title
Change in Serum Phosphorus Levels From Baseline to End of Treatment
Description
The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Change in Ferritin Levels From Baseline to End of Treatment
Description
The difference in ferritin levels between the value at the end of treatment (week 12) minus the baseline measurement.
Time Frame
12 Weeks
Title
Change in Hemoglobin Levels From Baseline to End of Treatment
Description
The difference in hemoglobin levels between the value at the end of treatment (week 12) minus the baseline measurement.
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage III to V Chronic Kidney Disease
Serum Phosphorus 4.0-6.0 mg/dL prior to Randomization
Ferritin 300 ng/mL or less
Transferrin Saturation (TSAT) 30% or less
Hemoglobin >9.0 and <12.0 g/dL
Must consume a minimum of 2 meals per day
Exclusion Criteria:
Parathyroidectomy within 24 weeks of study
gastrointestinal bleed or inflammatory bowel disease within 12 weeks of study
Requirement for dialysis or kidney injury within 8 weeks of study
Absolute requirement for oral iron, intravenous iron, Erythropoiesis-Stimulating Agent, blood transfusions, and Sensipar during the study
Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
Absolute requirement for vitamin C, niacin, or nicotinamide outside of multivitamins
History of hemochromatosis
Allergy to iron products
History of malignancy in last 5 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey Block, MD
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Glenn Chertow, MD
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Steven Fishbane, MD
Official's Role
Study Chair
Facility Information:
City
Tempe
State/Province
Arizona
Country
United States
City
La Mesa
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Edgewater
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Meridian
State/Province
Idaho
Country
United States
City
Evergreen Park
State/Province
Illinois
Country
United States
City
Bethesda
State/Province
Maryland
Country
United States
City
Springfield
State/Province
Massachusetts
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Pontiac
State/Province
Michigan
Country
United States
City
Reno
State/Province
Nevada
Country
United States
City
Great Neck
State/Province
New York
Country
United States
City
Mineola
State/Province
New York
Country
United States
City
Asheville
State/Province
North Carolina
Country
United States
City
Wilmington
State/Province
North Carolina
Country
United States
City
Orangeburg
State/Province
South Carolina
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25468387
Citation
Block GA, Fishbane S, Rodriguez M, Smits G, Shemesh S, Pergola PE, Wolf M, Chertow GM. A 12-week, double-blind, placebo-controlled trial of ferric citrate for the treatment of iron deficiency anemia and reduction of serum phosphate in patients with CKD Stages 3-5. Am J Kidney Dis. 2015 May;65(5):728-36. doi: 10.1053/j.ajkd.2014.10.014. Epub 2014 Nov 4.
Results Reference
derived
Learn more about this trial
Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis
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