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NCT03380936 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Study of Treatment for Subclinical AMR (Antibody-mediated Rejection) in Kidney Transplant Recipients
A Early Phase 1 study, sponsored by University of Colorado, Denver.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 4
- Enrollment target
NCT03380936 is a Early Phase 1 study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 4 participants.
The verdict
NCT03380936, a Early Phase 1 study, was terminated before completion, sponsored by University of Colorado, Denver.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This is a pilot study to determine if extended release Envarsus at an optimal level is just as effective as more invasive standard therapies for subclinical (mild) AMR (antibody mediated rejection) in kidney transplant patients. Subjects will be randomized to either conversion to Envarsus XR (extended release); or, to a standard of care regimen of plasma exchange/IVIG (intravenous immunoglobulin)/rituximab treatments.
Interventions
- DRUG Tacrolimus Extended Release Oral Tablet [Envarsus]
- OTHER Plasma Exchange and IVIG (Intravenous Immunoglobulin )
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2018-01-17 |
| Est. Completion | 2019-10-16 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03380936
The ClinicalTrials.gov registry entry for NCT03380936 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tacrolimus Extended Release Oral Tablet [Envarsus] is the first listed.
NCT03380936 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03380936 about?
NCT03380936 is a clinical study titled "Pilot Study of Treatment for Subclinical AMR (Antibody-mediated Rejection) in Kidney Transplant Recipients". This is a pilot study to determine if extended release Envarsus at an optimal level is just as effective as more invasive standard therapies for subclinical (mild) AMR (antibody mediated rejection) in kidney transplant patients. Subjects will be randomized to either conversion to Envarsus XR (extend...
What is the current status of trial NCT03380936?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 4 participants. The study started on 2018-01-17. Estimated completion is 2019-10-16.
What interventions are being tested in trial NCT03380936?
The interventions under investigation include: Tacrolimus Extended Release Oral Tablet [Envarsus] (DRUG), Plasma Exchange and IVIG (Intravenous Immunoglobulin ) (OTHER).
Who is sponsoring clinical trial NCT03380936?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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