drugset
drugset / Trial / NCT02723591

To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients

NCT02723591 ↗

Phase 4 Completed 599 enrolled Astellas Pharma Global Development, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2016-09-09
Primary completion
2019-06-14
Completion
2019-06-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tacrolimus Small molecule 0.15 mg/kg Oral

Indications

No indication recorded.