NCT01742624

Study to Evaluate the Safety and Efficacy of Advagraf vs Prograf in Kidney Transplantation Patients 1 Month After the Transplantation

Multicenter, Open-label, Parallel Clinical Investigation of the Safety and Efficacy of Advagraf® (Extended Release Tacrolimus) vs. Prograf® (Tacrolimus) in de Novo Kidney Recipients 1 Month After Kidney Transplantation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Astellas Pharma Korea, Inc. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy, safety, and drug compliance of Advagraf® (Extended Release Tacrolimus) by comparing the Advagraf® + steroid + Mycophenolate Mofetil combined therapy and the Prograf® + steroid + Mycophenolate Mofetil combined therapy in de novo kidney recipients 1 month after kidney transplantation.

Detailed description

This study is a multicenter, open-label, randomized, parallel, and comparative clinical trial. All the enrolled subjects will be treated with Prograf® (Tacrolimus), Basilixumab, Corticosteroids, and Mycophenolate Mofetil to suppress their immune system for one month (30 days) after their kidney transplant. After the one month, the experimental group (30 subjects) will be treated with Advagraf® (Extended Release Tacrolimus) instead of Prograf® (Tacrolimus), and the Corticosteroids and Mycophenolate Mofetil will be maintained. The control group (30 subjects) will continuously receive Prograf® (Tacrolimus), Corticosteroids, and Mycophenolate Mofetil. The clinical progress of the subjects in the experimental and control groups up to six months after their transplant will be investigated and compared.

Conditions

• de Novo Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Advagraf	oral
DRUG	Prograf	oral
DRUG	Corticosteroid	oral
DRUG	Mycophenolate mofetil	oral

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-12-05
• Last updated: 2014-10-10

Locations

3 sites across 1 country: South Korea