A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Kidney Transplant Recipients

Kidney Transplantation Clinical Trial

Official title:

A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF and Extended Release (XL) Tacrolimus /MMF in de Novo Kidney Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717678
• Other study ID #: PRGXLKTx-0701-TW
• Status: Completed
• Phase: Phase 3
• First received: July 16, 2008
• Last updated: December 16, 2015
• Start date: December 2007
• Est. completion date: April 2010

Study information

• Verified date: December 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF in de novo kidney transplant recipients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures

• Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living kidney transplant

• Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure

• Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization

Exclusion Criteria:

• Patient has previously received or is receiving an organ transplant other than a kidney

• Patient has received a kidney transplant from a non-heart beating donor

• Patient 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 or any other unstable medical condition that could interfere with the study objectives

• Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant

• Patient is receiving everolimus or enteric coated mycophenolic acid at any time during the study

• Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil or corticosteroids

• Patient is pregnant or lactating

• Patient is unlikely to comply with the visits scheduled in the protocol

• Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Host vs Graft Reaction
• Kidney Transplantation
• Transplantation Immunology

Intervention

Drug:
• Prograf-XL
oral
• Prograf
oral
• MMF
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Taiwan, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The patient and graft survival rates at 6 month post-transplant		6 months	No
Secondary	Efficacy failure at 6-month posttransplant.		6 months	No
Secondary	Incidence of biopsy confirmed acute rejection (Banff > 1) at 6 months and 12 months		6 months and 12 months	No
Secondary	1 year patient and graft survival		1 year	No

External Links

•   Link to results on Astellas Clinical Study Results Web site