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NCT03194321 · ClinicalTrials.gov registry record · Phase 4
Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients
A Phase 4 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT03194321: Completed Phase 4 study, sponsored by Cedars-Sinai Medical Center.
NCT03194321 is a Phase 4 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03194321, a Phase 4 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the safety of tacrolimus extended-release in HLA sensitized (HS, defined as panel reactive antibody ≥ 30%), kidney transplant recipients after desensitization with intravenous immunoglobulin (IVIG) and rituximab (also known as ritux) +/- plasma exchange (PLEX) per the standard of care with alemtuzumab induction.
Primary Outcome
To determine the safety of tacrolimus extended-release in HS kidney transplant recipients after desensitization with intravenous immunoglobulin (IVIG) and rituximab +/- plasma exchange (PLEX) per the standard of care and alemtuzumab induction. This will be measured by the rate of serious adverse events (SAEs) and treatment failure. Treatment failure is defined as a composite of biopsy proven acute rejection (BPAR), graft failure, or death. BPAR is defined as ≥ Banff 1A using the Banff 2007 crite
Interventions
- DRUG Tacrolimus Extended-Release Oral Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-09-11 |
| Est. Completion | 2020-10-27 |
| Phase | Phase 4 |
What the finished NCT03194321 record still lists
NCT03194321 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 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Tacrolimus Extended-Release Oral Capsule is the first listed.
NCT03194321 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03194321 about?
NCT03194321 is a clinical study titled "Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients". The purpose of this study is to demonstrate the safety of tacrolimus extended-release in HLA sensitized (HS, defined as panel reactive antibody ≥ 30%), kidney transplant recipients after desensitization with intravenous immunoglobulin (IVIG) and rituximab (also known as ritux) +/- plasma exchange (P...
What is the current status of trial NCT03194321?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2017-09-11. Estimated completion is 2020-10-27.
What interventions are being tested in trial NCT03194321?
The interventions under investigation include: Tacrolimus Extended-Release Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT03194321?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03194321's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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