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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: Active Phase 4 study of End Stage Renal Disease and Chronic Kidney Diseases, sponsored by Sreedhar Mandayam.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
determine change in average dose of ESA use when using Auryxia
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 |
What the registry record for NCT03055598 still lists
NCT03055598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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
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Where NCT03055598's enrollment target sits among peer trials
30 61st of 86 higher than 25 of 86 other End Stage Renal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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