Abstract: TH-OR028
Effect of Ferric Citrate on Erythropoiesis-Stimulating Agent (ESA) Use in ESRD Patients with Elevated Ferritin
Session Information
- Anemia and Iron Metabolism: Clinical Research
November 07, 2019 | Location: 150, Walter E. Washington Convention Center
Abstract Time: 05:54 PM - 06:06 PM
Category: Anemia and Iron Metabolism
- 202 Anemia and Iron Metabolism: Clinical
Authors
- Mandayam, Sreedhar A., UT MD Anderson Cancer Center, Bellaire, Texas, United States
- Mamlouk, Omar, University of Texas Health Science Center at Houston, Houston, Texas, United States
- Airy, Medha, Baylor College of Medicine, Houston, Texas, United States
- Rodriguez, Monica, Baylor College of Medicine, Houston, Texas, United States
- Perez, Jose Jesus, Baylor College of Medicine, Houston, Texas, United States
Background
Iron deficiency anemia is common in ESRD patients on hemodialysis. Dialysis facilities infuse intravenous Iron to ESRD patients based on protocols. Patients with elevated serum Ferritin (>1000 mcg/dL) are poorly responsive to IV Iron and concerns about infection risks lead to withholding IV Iron for ESRD patients with Ferritin >1000 mcg/dL. We investigated the efficacy of orally available Iron (Ferric Citrate) used as a phosphate binder on Iron parameters and ESA use in ESRD patients that have low Transferrin Saturations (Iron deficient) but high Ferritins in a pragmatic pilot clinical trial.
Methods
Protocol was approved by the BCM IRB. All patients on hemodialysis for at least 3 months at the US Renal Care Scott Street Dialysis unit were eligible. Patients were included if: Mean Serum Ferritin >1000 on 2 consecutive samples in 3 months, TSAT <30% on 2 consecutive samples in 3 months. Information collected at enrollment: Ferritin, TSAT, hemoglobin, ESA dose, Calcium, Phosphorus, and PTH. Subjects given Ferric Citrate 210 mg 2 tabs to be taken with meals (minimum 6/day) for 3 months. Clinicians and dieticians were allowed to change the dose of Ferric Citrate as clinically indicated. Monthly monitoring for labs was performed. This is an interim report after 25 patients
Results
Mean serum Ferritin and mean TSAT at enrollment were1169 ng/ml and 23.3 %. After 90 days of Ferric Citrate, the mean TSAT increased to 36% (31% increase) and the mean serum Ferritin was 1075 ng/ml (15% decrease).ESA use decreased from 59 units/week to 28 units/week by the end of the trial representing a 52% reduction in mean ESA dose/week/patient .Adverse events were minimal with diarrhea being the most common. 1 patients withdrew before starting drug and another withdrew after 1 month on drug due to constipation.
Conclusion
Ferric Citrate is a phosphate binder that can increase iron stores in ESRD patients that have high Ferritin and low TSAT and appears to reduce ESA use by 50% in these patients. ClinicalTrials.gov Identifier:NCT03055598
Effect of Ferric Citrate on ESA and Iron Parameters
| Parameter | Baseline | Visit 3 | Difference |
| Hemoglobin g/dL | 10 | 10.6 | 5% |
| TSAT % | 23.3 | 36.1 | 55% |
| Iron mcg/dL | 54.4 | 78.2 | 44% |
| ESA dose units/week | 59 | 28 | -52% |
Funding
- Commercial Support – Keryx Bio-Pharmaceuticals