drugset / Trial / NCT01649427

Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients

NCT01649427 ↗

Phase 4 Completed 73 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelBasic science

Summary

The purpose of this study was to investigate if Tacrolimus Hexal® has similar pharmacokinetic properties compared to Prograf® in de novo renal transplant patients and whether the comparable exposure resulted in similar renal function.

Timeline

Start
2012-10-17
Primary completion
2015-08-20
Completion
2015-08-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Tacrolimus Small molecule 0.5 mg —
Subject Tacrolimus Small molecule 1 mg —
Subject Tacrolimus Small molecule 1.5 mg —
Subject Tacrolimus Hexal Unknown 0.5 mg —
Subject Tacrolimus Hexal Unknown 1 mg —
Subject Tacrolimus Hexal Unknown 1.5 mg —

Indications

No indication recorded.