- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02492620
Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D (05D)
A Two-Arm, Open-Label, Standard of Care Control Evaluation of Ferric Citrate for the Transition From Chronic Kidney Disease Stage 4/5 to Chronic Kidney Stage 5D
Study Overview
Status
Intervention / Treatment
Detailed Description
This is an up to 50 week, phase 3, clinical trial in patients with estimated glomerular filtration rate (eGFR) ≤ 20 ml/min/1.73m2. It will be comprised of an up to 36-week non-dialysis period (NDP), or until such time as subjects require renal replacement therapy (RRT) with dialysis when they will immediately roll into a 12-week dialysis period (DP). The study will consist of up to 16 clinic visits over a maximum period of 50 weeks. There will be a screening period of up to 14 days after which subjects will be randomized into the NDP in a 2:1 ratio to receive either FC (n=150) or SOC (n=75). Each eligible participant will be randomized to either fixed dose open-label ferric citrate (FC) or standard of care (SOC) treatment. Participants randomized to SOC will receive care directed by their primary nephrologist throughout the study duration with the only restriction being that they cannot receive treatment with FC during the NDP or DP. Participants randomized to FC will receive it throughout the study duration.
220 participants were screened to randomize 200 subjects 2:1 (FC:SOC) into the NDP. It is anticipated that 35-45% of participants will reach the dialysis period (DP) during the 36 week follow up. Participants who initiate RRT with dialysis will enter the Dialysis Period (DP) during which those participants previously assigned to ferric citrate will continue to receive open-label ferric citrate and those previously assigned to SOC will receive open-label, non-FC phosphate binders at the discretion of their treating physician. During this period all participants will be treated to standard of care guidelines which suggest that if serum phosphate is above the upper limit of normal (4.5 mg/dL), it should be reduced. During the DP, dose of P binders, use of ESA, intravenous iron and blood transfusions will be at the discretion of the primary treating nephrologist. Participants assigned to the SOC treatment arm may not receive FC at any point during the study.
Only participants that begin permanent RRT with dialysis will be eligible to enter the 12 week DP. Participants that do not begin RRT after 9 months participation in the NDP will be deemed to have reach the end of study and have end of study procedures performed.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Colorado
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Denver, Colorado, United States, 80230
- Denver Nephrologists, P.C.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age >18 years at screening visit
- Serum phosphate > or equal to 3.0 mg/dL obtained at screening
- CKD with eGFR < or equal to 20 mL/min obtained at screening*
- Hemoglobin (Hgb) >8.0 g/dL obtained at screening
- TSAT <55% obtained at screening
- Females of child bearing potential with negative serum pregnancy test obtained at screening
- Willing and able to give written informed consent
- Anticipated to have > or equal to 8 weeks prior to need for initiating RRT in the opinion of the investigator
Exclusion Criteria:
- Liver enzymes (ALT/AST) >X3 times upper limit of normal at screening
- Use of IV iron, blood transfusions or ESA agents within 2 weeks prior to the screening visit and prior to the Day 1 visit.
- Evidence of acute kidney injury (i.e., no CKD) or planned need for RRT within 12 weeks of screening
- Scheduled kidney transplant within 24 weeks of screening
- Contra-indication to ferric citrate: iron overload syndrome, allergic reaction or known intolerance to ferric citrate
- Clinically significant medical condition felt to interfere with tolerance of oral medication
- Life expectancy < 6 months or confirmed conviction that subject does NOT want to initiate RRT despite a decline in kidney function
- Active drug or alcohol dependence or abuse (excluding tobacco use or marijuana use) within the 12 months prior to screening (in the opinion of the PI)
- Psychiatric disorder that interferes with the subject's ability to comply with the study protocol in the opinion of the PI
- Any other medical condition that, in the opinion of the PI, renders the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
- Inability to cooperate with study personnel or study procedures
- Females who are pregnant or breastfeeding
- Receiving or has received any investigational drug with in the past 30 days prior to the Day 1 visit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ferric Citrate
Ferric citrate (FC) will be supplied as tablets containing 210mg of ferric iron (as 1g ferric citrate) to those subjects randomized to FC.
These participants will be initiated on study drug with a fixed dose of FC beginning with 2 tablet per meal.
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Auryxia (ferric citrate) is a non calcium based phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis
Other Names:
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No Intervention: Standard of Care (SOC)
Participants may receive open-label, non-FC phosphate binders at the discretion of their treating physician.
During the Dialysis Period, dose of phosphate binders, use of ESA, intravenous iron and blood transfusions will be at the discretion of the primary treating nephrologist.
Participants assigned to the SOC treatment arm may not receive FC at any point during the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum phosphate value prior to starting renal replacement therapy
Time Frame: baseline
|
baseline
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum hemoglobin prior to starting renal replacement therapy
Time Frame: baseline
|
baseline
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Serum transferrin saturation prior to starting renal replacement therapy
Time Frame: baseline
|
baseline
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Serum fibroblast growth factor 23 prior to starting renal replacement therapy
Time Frame: baseline
|
baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative dose of erythropoietin analog
Time Frame: Baseline visit to 90 days after starting renal replacement therapy
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Total dose of ESA received in units from baseline visit to 90 days post renal replacement
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Baseline visit to 90 days after starting renal replacement therapy
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Cumulative dose of intravenous iron
Time Frame: Baseline visit to 90 days after starting renal replacement therapy
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Total dose of intravenous iron received in units from baseline visit to 90 days post renal replacement
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Baseline visit to 90 days after starting renal replacement therapy
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Geoffrey A Block, MD, Denver Nephrologists, P.C.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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