CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Tacrolimus Extended-Release Oral Capsuledrug
Likely dose
Tacrolimus Extended-Release Oral Capsule 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03194321
NCT03194321Phase 4Completed
CompareCT.gov

A Prospective, Pilot Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in HLA Sensitized Kidney Transplant Recipients

Cedars-Sinai Medical Center·interventional·Posted Jun 21, 2017·Updated Jan 19, 2022

In Brief

A Phase 4 clinical trial evaluating Tacrolimus Extended-Release Oral Capsule for End Stage Renal Disease. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease
CountriesUnited States
CollaboratorsAstellas Pharma Inc

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJun 21, 2017
Enrollment StartSep 11, 2017
Primary CompletionOct 27, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 9.0 years ago

Interventions

Tacrolimus Extended-Release Oral Capsuledrug

Maintenance immunosuppression will consist of tacrolimus extended-release, mycophenolate mofetil 500mg twice daily or mycophenolate sodium 360mg twice daily, and prednisone.