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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: Clinical Trial Early Phase 1 study, sponsored by University of Colorado, Denver.
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Any increase or reduction in ptc+g+C4d score by Banff 2013 criteria) from baseline (pre-treatment) to 6 month (post-treatment initiation). Analysis will comprise exact chi-squared tests for comparison of binomial proportions of histological response between the two treatment groups.
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 |
Why NCT03380936 stopped before completion
NCT03380936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Tacrolimus Extended Release Oral Tablet [Envarsus] is the first listed.
NCT03380936 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03380936's enrollment target sits among peer trials
4 1921st of 2000 higher than 53 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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