Ferric Citrate in ESRD Pilot Project

• Status: Active, not recruiting
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sreedhar Mandayam
• Collaborator: Keryx Biopharmaceuticals
• Treatments: Citric Acid

Criteria

Inclusion Criteria:

1. Signed informed consent prior to any study specific procedures

2. Male and females aged 18 years and older

3. In the Investigator's opinion, expected to survive at least 3 months

4. Able to tolerate phosphate binders

5. ESRD and on dialysis for over 90 days

6. Deemed stable by Investigator

7. Serum Ferritin >1000 ng/ml (measured as average of at least 2 values in the last 3 months +/- 10 days)

8. TSAT < 30% ( measured as average of at least 2 values in the last 30 days, +/- 10 days)

9. Hemoglobin < 12g/dl (measured as average of at least 2 values in the last 30 days, +/- 10 days)

10. Currently on ESA for at least 1 month, as per dialysis unit protocol

Exclusion Criteria:

1. Inability or refusal to give informed consent

2. Subject unwilling to take study medication for 3 months

3. Currently on IV Iron

4. Currently on Auryxia as phosphate binder (or received in prior 3 months)

5. Deemed non-compliant by care team for dialysis or medication

6. Active gastrointestinal bleed

7. Inflammatory bowel disease

8. History of malignancy within 5 years before screening (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ, or a malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence).

9. Known allergy to oral iron products

10. Pregnant

11. Breastfeeding