Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02974686 · ClinicalTrials.gov registry record · Phase 4
Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation
A Phase 4 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT02974686 is a Phase 4 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 1 participants.
The verdict
NCT02974686, a Phase 4 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
Patients who receive renal transplantation at Barnes Jewish Hospital (BJH) are placed on triple maintenance immunosuppression, which means that patients take 3 types of immunosuppression drugs to suppress their immune system including tacrolimus, mycophenolate (MPA), and prednisone. However, due to the effects of MPA on the gastrointestinal tract, patients often complain of GI adverse effects. Current practice is to either dose-reduce MPA or convert the patient to an alternative agent, typically Azathioprine. Both of these strategies have limitations, largely due to concerns related to efficacy. Everolimus (EVR) has demonstrated similar efficacy to MPA in renal transplantation and may offer a benefit related to GI adverse effects, so the investigators will convert patients to EVR in this study. Patients who are within their first year post-transplant will be converted to EVR upon enrollment in the study, and serial measurements ,or a series of measurements looking for an increase or decrease over time, of GI adverse effects will be conducted over 1 year post-enrollment.
Interventions
- DRUG Everolimus
- DRUG Mycophenolic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2016-11 |
| Est. Completion | 2019-09 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02974686
The ClinicalTrials.gov registry entry for NCT02974686 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT02974686 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02974686 about?
NCT02974686 is a clinical study titled "Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation". Patients who receive renal transplantation at Barnes Jewish Hospital (BJH) are placed on triple maintenance immunosuppression, which means that patients take 3 types of immunosuppression drugs to suppress their immune system including tacrolimus, mycophenolate (MPA), and prednisone. However, due to ...
What is the current status of trial NCT02974686?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2016-11. Estimated completion is 2019-09.
What interventions are being tested in trial NCT02974686?
The interventions under investigation include: Everolimus (DRUG), Mycophenolic Acid (DRUG).
Who is sponsoring clinical trial NCT02974686?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
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.