Ferric Citrate in ESRD Pilot Project

NCT03055598 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: H-39364 Ferric Citrate in ESRD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

End Stage Renal Disease; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (3)

• change in average weekly ESA dose determination from baseline to day 90

  determine change in average dose of ESA use when using Auryxia

  day 90

• change in mean serum iron from baseline to day 90

  assess change in mean serum iron while using Auryxia

  day 90

• change in mean ferritin from baseline to day 90

  assess change in mean ferritin while using Auryxia

  day 90

Secondary Outcomes (9)

• change in average weekly ESA dose determination

  baseline, day 30, day 60

• change in mean serum iron

  baseline, day 30, day 60

• change in mean ferritin

  baseline, day 30, day 60

• TSAT value

  baseline, day 30, day 60, day 90

• hemoglobin value

  baseline, day 30, day 60, day 90

Study Arms (1)

Ferric Citrate

EXPERIMENTAL

Ferric Citrate (Auryxia) will be dosed initially at 2 tablets three times a day (with meals).

Drug: Ferric Citrate

Interventions

Ferric Citrate DRUG

Doses can be adjusted as needed by 1 to 2 tablets up to a maximum of 12 tablets daily. Dose can be titrated at 1-week or longer intervals.

Also known as: Auryxia

Ferric Citrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to any study specific procedures
• Male and females aged 18 years and older
• In the Investigator's opinion, expected to survive at least 3 months
• Able to tolerate phosphate binders
• ESRD and on dialysis for over 90 days
• Deemed stable by Investigator
• Serum Ferritin \>1000 ng/ml (measured as average of at least 2 values in the last 3 months +/- 10 days)
• TSAT \< 30% ( measured as average of at least 2 values in the last 30 days, +/- 10 days)
• Hemoglobin \< 12g/dl (measured as average of at least 2 values in the last 30 days, +/- 10 days)
• Currently on ESA for at least 1 month, as per dialysis unit protocol

You may not qualify if:

• Inability or refusal to give informed consent
• Subject unwilling to take study medication for 3 months
• Currently on IV Iron
• Currently on Auryxia as phosphate binder (or received in prior 3 months)
• Deemed non-compliant by care team for dialysis or medication
• Active gastrointestinal bleed
• Inflammatory bowel disease
• 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).
• Known allergy to oral iron products
• Pregnant
• Breastfeeding

Sponsors & Collaborators

• Sreedhar Mandayam: lead
• Keryx Biopharmaceuticals: collaborator

Study Sites (2)

Harris Health System - Riverside Dialysis Center

Houston, Texas, 77004, United States

Location

US Renal Care- Scott Street

Houston, Texas, 77021, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Interventions

ferric citrate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sreedhar Mandayam, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 16, 2017
• Study Start: May 11, 2017
• Primary Completion: September 30, 2019
• Study Completion: February 1, 2020
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)