Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D (05D)
|Chronic Kidney Disease Hyperphosphatemia Iron Deficiency Anemia Renal Insufficiency||Drug: Ferric Citrate||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Serum phosphate value prior to starting renal replacement therapy [ Time Frame: baseline ]
- Serum hemoglobin prior to starting renal replacement therapy [ Time Frame: baseline ]
- Serum transferrin saturation prior to starting renal replacement therapy [ Time Frame: baseline ]
- Serum fibroblast growth factor 23 prior to starting renal replacement therapy [ Time Frame: baseline ]
- Cumulative dose of erythropoietin analog [ Time Frame: Baseline visit to 90 days after starting renal replacement therapy ]Total dose of ESA received in units from baseline visit to 90 days post renal replacement
- Cumulative dose of intravenous iron [ Time Frame: Baseline visit to 90 days after starting renal replacement therapy ]Total dose of intravenous iron received in units from baseline visit to 90 days post renal replacement
|Study Start Date:||March 2015|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
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.
Drug: Ferric Citrate
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 Name: Auryxia
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.
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.
Approximately 300 participants will be screened to randomize approximately 225 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02492620
|Contact: Geoffrey A Block, MDemail@example.com|
|Contact: Martha S Persky, RN, CCRPfirstname.lastname@example.org|
|United States, Colorado|
|Denver Nephrologists, P.C.||Recruiting|
|Denver, Colorado, United States, 80230|
|Contact: Martha S. Persky, RN, CCRP 303-364-4775 email@example.com|
|Principal Investigator: Geoffrey A Block, MD|
|Principal Investigator:||Geoffrey A Block, MD||Denver Nephrologists, P.C.|