Ferric Citrate in ESRD Pilot Project (NCT03055598)
Effect of Auryxia on ESA Utilization in ESRD Patients With High Ferritin & Low Transferrin Saturation: A Pilot Project
๐ฉบ Plain-English Summary (8th-Grade Level)
This research study is for participants that have End Stage Renal Disease (ESRD). ESRD is the last stage of chronic kidney disease. Anemia is very common in ESRD patients and require erythropoiesis-stimulating agents (ESAs) for treatment. Anemia happens when there are not enough red blood cells in your body. ESAs work by helping the bone marrow to produce red blood cells. There are two ESAs licensed for the treatment of anemia of Chronic Kidney Disease (CKD) in the Unites States: epoetin alfa and darbopoetin alfa. ESA therapy is considered safe. However, major adverse effects should be acknowledged, including an increased risk of death, thromboembolic complications, stroke, heart attack, aplastic anemia, tumor progression, and others. To minimize risks of these adverse events, careful monitoring of hemoglobin levels, along with adjustment of ESA dosing, to maintain the lowest hemoglobin level clinically needed is recommended. Ferric Citrate, also called Auryxia, is an iron-based phosphate binder that may decrease ESA usage while maintaining hemoglobin levels. Phosphate binders are medications used to reduce the body's absorption of phosphate. In a prior study, it was seen that some laboratory values, such as iron levels, changed positively in response to Auryxia. In this study we want to see if using Auryxia will cause a change in laboratory values and lower the use of ESAs in ESRD patients.
Who can join: Review the eligibility criteria below.
Location: Harris Health System - Riverside Dialysis Center โ Houston, Texas
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (2 Sites)
- Harris Health System - Riverside Dialysis Center โ Houston, Texas
- US Renal Care- Scott Street โ Houston, Texas
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in End Stage Renal Disease
- Light Therapy in End Stage Kidney Disease โ Philadelphia, Pennsylvania
- Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients โ Washington D.C., District of Columbia
- Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease โ New York, New York
- Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis โ San Antonio, Texas
- PReSeRVE-HD: Observational Study of the Merit HeROยฎ Graft and Super HeROยฎ in Patients on Hemodialysis โ Washington D.C., District of Columbia
Explore by condition: All End Stage Renal Disease clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.