NCT02268201

A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule

A Randomized, Open-label, Multi-center Clinical Trial to Compare Efficacy and Safety of Cyclosporine-based and Switching Cyclosporine to Tacrolimus of Two Forms-based Immunosuppressive Therapy in Renal Transplant (KTx) Recipients

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Astellas Pharma China, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

KTx recipients receiving cyclosporine-based immunosuppressive therapy, and in the opinion of the investigator would benefit from switch to a tacrolimus-based immunosuppression, will switch the immunosuppressive therapy to a tacrolimus-based one. Efficacy and safety of patients will be observed for 52 weeks.

Detailed description

The primary objective of this study is to compare the adherence of kidney transplant recipients treated with Prograf and Advagraf regimens. The secondary objectives of this study are: * To compare the renal function (eGFR) in KTx recipients treated with Cyclosporine and Tacrolimus regimens. * To compare the QoL of KTx recipients treated with Cyclosporine and Tacrolimus regimens. * To compare the efficacy of Cyclosporine and Tacrolimus regimens in KTx recipients. * To compare the safety of Cyclosporine and Tacrolimus regimens in KTx recipients.

Conditions

• Kidney Transplant Recipients

Interventions

Type	Name	Description
DRUG	Advagraf	oral
DRUG	Prograf	oral

Timeline

• Start date: 2013-07-23
• Primary completion: 2015-03-31
• Completion: 2015-03-31
• First posted: 2014-10-20
• Last updated: 2024-11-01

Locations

7 sites across 1 country: China