CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 599 enrolled
Drug / intervention
Tacrolimus +1 moredrug
Likely dose
Tacrolimus (Astagraf XL extended-release and/or immediate-release oral capsule); specific doses not stated in protocolAI-extracted
Key inclusion· 4
  • ✓Recipient of a de novo kidney from living or deceased donor (including en bloc pediatric donor ≥5 years and >20 kg)
  • ✓If deceased donor, Kidney Donor Profile Index (KDPI) ≤85 (includes DCD and extended criteria donors if KDPI ≤85)
  • ✓At least one antigen mismatch at major MHC (class I or class II)
  • ✓Will receive induction immunotherapy with T-cell depleting agent, anti-CD52 monoclonal antibody, or IL-2 co-stimulation blocker (steroid-only induction does not satisfy this)
Key exclusion· 20
  • ✕Positive test for latent TB without adequate prior anti-microbial therapy or requiring TB prophylaxis post-transplant
  • ✕Uncontrolled concomitant infection or unstable medical condition interfering with study objectives
  • ✕Significant liver disease: AST or ALT >3 times upper normal limit in past 28 days
  • ✕Currently taking or planned maintenance on another extended-release tacrolimus formulation post-transplant

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

Search/NCT02723591
NCT02723591Phase 4Completed
CompareCT.gov

Astagraf XL® to Understand the Impact of Immunosuppression on De Novo DSA Development and Chronic Immune Activation in Kidney Transplantation

Astellas Pharma Global Development, Inc.·interventional·Posted Mar 30, 2016·Updated Dec 18, 2024

In Brief

A Phase 4 clinical trial evaluating Tacrolimus and Tacrolimus immediate release for Kidney Transplantation. Completed, enrolled 599 participants across 30 sites.

Detailed Summary

This study compared the incidence of a two-part composite endpoint consisting of de novo donor specific antibody (DSA) formation or a designation of immune activation (IA) on peripheral blood molecular profiling in participants maintained on twice daily, immediate-release tacrolimus versus those maintained on Astagraf XL in the first year post-transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 30, 2016
Enrollment StartSep 9, 2016
Primary CompletionJun 14, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.3 years ago

Interventions

Tacrolimusdrug

Oral Capsule

Tacrolimus immediate releasedrug

Oral Capsule