A Study to Demonstrate Safety and Efficacy of Advagraf in Patients Undergoing Kidney or Liver Transplantation in India

Phase 4

Completed

• Conditions: Liver Transplantation; Kidney Transplantation
• Interventions: Drug: Advagraf

• Registration Number: NCT02432053
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The objective of the study is to demonstrate safety and efficacy of once-daily Advagraf in adult population undergoing kidney or liver transplantation in India.

Detailed Description

This is a phase IV, multi-centre, open label prospective study of once daily Advagraf in 200 patients undergoing kidney or liver transplantation in India. Adult patients undergoing kidney or liver transplantation and meeting all other eligibility criteria will be enrolled in the study. Enrolled patients will be administered once daily dose of Advagraf for 12 weeks. During these 12 weeks a total of 9 regular visits will be undertaken.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-04
• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-04-28
• Last Update Submitted: 2015-04-28
• Study First Posted: 2015-05-01
• Last Update Posted: 2015-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transplantation	Advagraf	Advagraf

Primary Outcome Measures

Name	Time	Method
Renal function (evaluated by level of Serum Creatinine)	from Day 0 to Week 12
Lipid profile	0, 4, and 12-week
Incidence of New-Onset Diabetes Mellitus After Transplant (NODAT)	from Day 0 to Week 12	NODAT is defined as a composite endpoint consisting of first occurrence of one of 4 parameters: (1) Two fasting plasma glucose (FPG) levels \> 126 mg/dL which are \> 30 days apart. (2) Oral hypoglycemic agent use for \> 30 consecutive days. (3) Insulin therapy for \> 30 consecutive days and (4) HbA1c \> 6.5%
Incidence of infection	from Day 0 to Week 12
For kidney transplant patients: Event rate of patients with biopsy-confirmed acute rejections (BCAR) ≥ Grade I according to -The Banff 2007 working classification of renal allograft pathology within the first 12 weeks following kidney transplantation	from Day 0 to Week 12	The biopsy shall be performed prior to the initiation of any anti-rejection therapy and as soon as possible after the onset of clinical / laboratory signs indicative of possible rejection
For liver transplant patients: Event rate of patients with biopsy-confirmed acute rejections (BCAR) with Rejection Activity Index of ≥ 4, within the first 12 weeks following liver transplantation	from Day 0 to Week 12	The biopsy shall be performed prior to the initiation of any anti-rejection therapy and as soon as possible after the onset of clinical / laboratory signs indicative of possible rejection. Biopsy-confirmed acute rejections (BCAR) with Rejection Activity Index was defined according to The 1997 Banff schema for grading liver allograft rejection

Secondary Outcome Measures

Name	Time	Method
Incidence of corticosteroid resistant rejection	from Day 0 to Week 12
Time to first biopsy confirmed acute rejection episode	from Day 0 to Week 12
Incidence of corticosteroid sensitive rejection	from Day 0 to Week 12
Incidence of use of anti-lymphocyte antibodies	from Day 0 to Week 12
Overall frequency of acute rejection episodes	from Day 0 to Week 12
Severity of biopsy confirmed acute rejections	from Day 0 to Week 12
Graft loss	Week 12
Death	Week 12