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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 is a Phase 4 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03194321
The ClinicalTrials.gov registry entry for NCT03194321 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tacrolimus Extended-Release Oral Capsule is the first listed.
NCT03194321 reports 0 study locations.
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.
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