Chronic Kidney Disease Clinical Trial
— 05DOfficial 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
NCT number | NCT02492620 |
Other study ID # | 05D |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | November 2017 |
Verified date | July 2018 |
Source | Denver Nephrologists, P.C. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P, FGF23) and furthermore, will result in a reduced need for ESA and intravenous iron. The investigators further hypothesize that effective treatment of anemia and mineral metabolism with FC in the pre-dialysis and transition period will result in improved physical functioning, reduced hospitalization and reduced total cost of care when compared to participants receiving contemporaneously provided standard of care therapy.
Status | Completed |
Enrollment | 200 |
Est. completion date | November 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age >18 years at screening visit 2. Serum phosphate > or equal to 3.0 mg/dL obtained at screening 3. CKD with eGFR < or equal to 20 mL/min obtained at screening* 4. Hemoglobin (Hgb) >8.0 g/dL obtained at screening 5. TSAT <55% obtained at screening 6. Females of child bearing potential with negative serum pregnancy test obtained at screening 7. Willing and able to give written informed consent 8. Anticipated to have > or equal to 8 weeks prior to need for initiating RRT in the opinion of the investigator Exclusion Criteria: 1. Liver enzymes (ALT/AST) >X3 times upper limit of normal at screening 2. Use of IV iron, blood transfusions or ESA agents within 2 weeks prior to the screening visit and prior to the Day 1 visit. 3. Evidence of acute kidney injury (i.e., no CKD) or planned need for RRT within 12 weeks of screening 4. Scheduled kidney transplant within 24 weeks of screening 5. Contra-indication to ferric citrate: iron overload syndrome, allergic reaction or known intolerance to ferric citrate 6. Clinically significant medical condition felt to interfere with tolerance of oral medication 7. Life expectancy < 6 months or confirmed conviction that subject does NOT want to initiate RRT despite a decline in kidney function 8. 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) 9. Psychiatric disorder that interferes with the subject's ability to comply with the study protocol in the opinion of the PI 10. 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 11. Inability to cooperate with study personnel or study procedures 12. Females who are pregnant or breastfeeding 13. Receiving or has received any investigational drug with in the past 30 days prior to the Day 1 visit |
Country | Name | City | State |
---|---|---|---|
United States | Denver Nephrologists, P.C. | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
Denver Nephrologists, P.C. | Keryx Biopharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cumulative dose of erythropoietin analog | Total dose of ESA received in units from baseline visit to 90 days post renal replacement | Baseline visit to 90 days after starting renal replacement therapy | |
Other | Cumulative dose of intravenous iron | Total dose of intravenous iron received in units from baseline visit to 90 days post renal replacement | Baseline visit to 90 days after starting renal replacement therapy | |
Primary | Serum phosphate value prior to starting renal replacement therapy | baseline | ||
Secondary | Serum hemoglobin prior to starting renal replacement therapy | baseline | ||
Secondary | Serum transferrin saturation prior to starting renal replacement therapy | baseline | ||
Secondary | Serum fibroblast growth factor 23 prior to starting renal replacement therapy | baseline |
Status | Clinical Trial | Phase | |
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