Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Denver Nephrologists, P.C.
• Collaborator: Keryx Biopharmaceuticals
• Treatments: Citric Acid; Ferric Compounds

Criteria

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