A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients

Phase 3

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: MR4; Drug: Prograf

• Registration Number: NCT00720265
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2008-07
• Study First Submitted: 2008-07-18
• Study First Submitted QC: 2008-07-18
• Last Update Submitted: 2008-07-18
• Study First Posted: 2008-07-22
• Last Update Posted: 2008-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• Patient must receive first oral dose of randomized study drug 2days(min 1day) prior to transplant procedure
• Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment

Exclusion Criteria

• Patient has previously received an organ transplant other than a kidney
• Patient has received a Kidney transplant from non-heart beating donor or a cadaveric donor
• Patients has received an ABO incompatible donor kidney
• Recipient or donor is known to be seropositive for human immunodeficiency virus(HIV)
• Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
• Patient has significant liver, disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
• Patient has an uncontrolled concomitant infection(including Hepatitis B, Hepatitis C)or any other unstable medical condition that could interfere with the study objectives
• Patient is currently taking or has been taking an immunosuppressive agents in the 30 days prior to transplant(except from two days prior to transplant)
• Patient has a known hypersensitivity to tacrolimus
• Patient is pregnant or lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	MR4	-
1	Prograf	-

Primary Outcome Measures

Name	Time	Method
Acute rejection within 24 weeks (6 months)	6 months

Secondary Outcome Measures

Name	Time	Method
Incidence of biopsy-proven acute rejection (Banff Grade ≥ 1)	at 6 months
Time to first acute rejection episode	for 6 months
6 month patient and graft survival rate	at 6 months
Severity of acute rejection	6 months
Adverse events, laboratory parameters and vital signs	Throughout trial