Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03055598 · ClinicalTrials.gov registry record · Phase 4
Ferric Citrate in ESRD Pilot Project
A Phase 4 study of End Stage Renal Disease and Chronic Kidney Diseases, sponsored by Sreedhar Mandayam.
- Active
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT03055598 is a Phase 4 study of End Stage Renal Disease and Chronic Kidney Diseases that is active but no longer recruiting, run by Sreedhar Mandayam. The registered enrollment target is 30 participants, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03055598, a Phase 4 study of End Stage Renal Disease and Chronic Kidney Diseases, is active but no longer recruiting, sponsored by Sreedhar Mandayam.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- DRUG Ferric Citrate
Study Locations (2)
Texas
- Harris Health System - Riverside Dialysis Center - Houston
- US Renal Care- Scott Street - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-05-11 |
| Est. Completion | 2020-02 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03055598
The ClinicalTrials.gov registry entry for NCT03055598 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (96% lower). The listed sponsor is Sreedhar Mandayam, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 1 intervention - of which Ferric Citrate is the first listed.
NCT03055598 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT03055598 about?
NCT03055598 is a clinical study titled "Ferric Citrate in ESRD Pilot Project". 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 y...
What is the current status of trial NCT03055598?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2017-05-11. Estimated completion is 2020-02.
What conditions does trial NCT03055598 study?
This clinical trial studies the following conditions: End Stage Renal Disease, Chronic Kidney Diseases.
What interventions are being tested in trial NCT03055598?
The interventions under investigation include: Ferric Citrate (DRUG).
Who is sponsoring clinical trial NCT03055598?
This trial is sponsored by Sreedhar Mandayam, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03055598 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for End Stage Renal Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
One-month Latent Tuberculosis Treatment for Renal Transplant Candidates
ACTIVE NOT RECRUITING · Phase 4
-
Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients
COMPLETED · Phase 4
-
A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP
COMPLETED · Phase 4
-
Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis
COMPLETED · Phase 4
-
Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
COMPLETED · Phase 4
-
Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation
COMPLETED · Phase 4
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.