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NCT04225988 · ClinicalTrials.gov registry record · Phase 4
Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients
A Phase 4 study of Kidney Transplant Rejection, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04225988: Completed Phase 4 study of Kidney Transplant Rejection, sponsored by Cedars-Sinai Medical Center.
NCT04225988 is a Phase 4 study of Kidney Transplant Rejection that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 20 participants, below the 803-participant average among 8 other Kidney Transplant Rejection trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04225988, a Phase 4 study of Kidney Transplant Rejection, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, open-label, controlled clinical trial designed to compare clinical outcomes after kidney transplantation using extended-release tacrolimus (Envarsus XR) versus immediate tacrolimus among highly-sensitized kidney transplant recipients. Outcomes to be assessed include the incidence of biopsy-proven acute rejection at 12 months, the presence of de novo and pre-existing donor-specific HLA antibodies, estimated glomerular filtration rate, and the level of donor-derived cell-free DNA.
Primary Outcome
To assess whether the occurence of biopsy-proven acute rejection within 12 months of transplant is comparable between HS patients maintained on Envarsus XR and immediate-release tacrolimus.
Conditions Studied
Interventions
- DRUG Extended-release tacrolimus
- DRUG Immediate-release tacrolimus
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-01-09 |
| Est. Completion | 2023-07-11 |
| Phase | Phase 4 |
What the finished NCT04225988 record still lists
NCT04225988 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 803-participant average among 8 other Kidney Transplant Rejection trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Kidney Transplant Rejection appearing as the primary indexed condition, and to 2 interventions - of which Extended-release tacrolimus is the first listed.
NCT04225988 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04225988 about?
NCT04225988 is a clinical study titled "Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients". This is a randomized, open-label, controlled clinical trial designed to compare clinical outcomes after kidney transplantation using extended-release tacrolimus (Envarsus XR) versus immediate tacrolimus among highly-sensitized kidney transplant recipients. Outcomes to be assessed include the inciden...
What is the current status of trial NCT04225988?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2020-01-09. Estimated completion is 2023-07-11.
What conditions does trial NCT04225988 study?
This clinical trial studies the following conditions: Kidney Transplant Rejection.
What interventions are being tested in trial NCT04225988?
The interventions under investigation include: Extended-release tacrolimus (DRUG), Immediate-release tacrolimus (DRUG).
Who is sponsoring clinical trial NCT04225988?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04225988 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Transplant Rejection
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 NCT04225988's enrollment target sits among peer trials
20 8th of 8 higher than 1 of 8 other Kidney Transplant Rejection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplant Rejection 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
-
Trifecta-Kidney cfDNA-MMDx Study
RECRUITING
-
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
RECRUITING
-
Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA
RECRUITING
-
Microbiome and Immunosuppression: The Mission Study
ACTIVE NOT RECRUITING
-
The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
ACTIVE NOT RECRUITING
-
Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection
ACTIVE NOT RECRUITING
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