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NCT03229265 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetic Study of Tacrolimus and Mycophenolate Mofetil in Kidney Transplant Recipients With Hyperkalemia Receiving Patiromer
A Phase 4 study of Kidney Transplant and Hyperkalemia, sponsored by The Rogosin Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT03229265: Completed Phase 4 study of Kidney Transplant and Hyperkalemia, sponsored by The Rogosin Institute.
NCT03229265 is a Phase 4 study of Kidney Transplant and Hyperkalemia that has completed, run by The Rogosin Institute. The registered enrollment target is 8 participants, below the 1,898-participant average among 30 other Kidney Transplant trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03229265, a Phase 4 study of Kidney Transplant and Hyperkalemia, has completed, sponsored by The Rogosin Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Hyperkalemia (high potassium in blood) is a common condition found in kidney transplant patients. Risk factors include poor kidney function and exposure to various drugs. Regardless of the causes, current treatment options are limited. Previously, the only available potassium binder for lowering potassium in the blood is sodium polystyrene sulfonate, which has unknown drug interaction profile with transplant medications. Patiromer is a newly approved potassium binder indicated for the treatment of hyperkalemia. Kidney transplant patients with hyperkalemia may benefit from patiromer. However, the interaction of patiromer and transplant medications has not been studied. The goal of this study is to look into the drug interactions between patiromer and transplant medications.
Primary Outcome
Investigate the pharmacokinetics of tacrolimus and mycophenolate mofetil in kidney transplant recipients receiving patiromer. Investigators will obtain serum levels of tacrolimus and mycophenolate mofetil before and after the administration of the study drug patiromer. Investigators will measure the areas under the curve of tacrolimus and mycophenolate mofetil before and after exposure to patiromer.
Conditions Studied
Interventions
- DRUG Patiromer
Study Locations (1)
New York
- The Rogosin Institute - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2019-08-07 |
| Phase | Phase 4 |
What the finished NCT03229265 record still lists
NCT03229265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,898-participant average among 30 other Kidney Transplant trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Kidney Transplant appearing as the primary indexed condition, and to 1 intervention - of which Patiromer is the first listed.
NCT03229265 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03229265 about?
NCT03229265 is a clinical study titled "Pharmacokinetic Study of Tacrolimus and Mycophenolate Mofetil in Kidney Transplant Recipients With Hyperkalemia Receiving Patiromer". Hyperkalemia (high potassium in blood) is a common condition found in kidney transplant patients. Risk factors include poor kidney function and exposure to various drugs. Regardless of the causes, current treatment options are limited. Previously, the only available potassium binder for lowering pot...
What is the current status of trial NCT03229265?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2017-08-01. Estimated completion is 2019-08-07.
What conditions does trial NCT03229265 study?
This clinical trial studies the following conditions: Kidney Transplant, Hyperkalemia.
What interventions are being tested in trial NCT03229265?
The interventions under investigation include: Patiromer (DRUG).
Who is sponsoring clinical trial NCT03229265?
This trial is sponsored by The Rogosin Institute, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03229265 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Transplant
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.
Where NCT03229265's enrollment target sits among peer trials
8 31st of 30 the lowest of 30 other Kidney Transplant trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplant 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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