DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplantation

Intervention: Tacrolimus Modified Release (MR) (Drug); Tacrolimus (Drug); cyclosporine microemulsion (Drug); mycophenolate mofetil (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma Global Development

Summary

The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney transplant recipients.

Clinical Details

Official title: A Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF, Modified Release (MR) Tacrolimus/MMF and Neoral (Cyclosporine)/MMF in de Novo Kidney Transplant Recipients

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

Primary outcome: Percentage of Participants With Efficacy Failure

Secondary outcome:

Patient Survival at One Year

Graft Survival at One Year

Percentage of Participants With Biopsy Confirmed Acute Rejection at 6 and 12 Months

Time to First Biopsy-confirmed Acute Rejection Episode

Number of Participants Requiring Anti-lymphocyte Antibody Therapy for Treatment of Rejection

Severity of Acute Rejection

Number of Participants Experiencing Multiple Rejection Episodes

Number of Participants With Clinically Treated Acute Rejection Episodes

Number of Participants With Treatment Failure

Number of Participants Who Crossed Over Due to Treatment Failure

Change From Month 1 in Serum Creatinine at Month 6 and Month 12

Change From Month 1 in Creatinine Clearance at Month 6 and Month 12

Kaplan-Meier Estimate of Patient Survival at the End of the Study

Kaplan-Meier Estimate of Graft Survival at the End of the Study

Detailed description: This was a 3 arm randomized, open-label, comparative, multi-center study in de novo kidney transplant recipients at 60 centers in the U. S., Canada and Brazil. The study consisted of a 1-year post-transplant efficacy and safety study with a clinical continuation phase of a minimum of 2 years or until commercial availability of tacrolimus modified release, unless the Data Safety Monitoring Board or sponsor specified otherwise.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Recipient of a primary or retransplanted non-human leukocyte antigen (HLA)-identical

living or non-HLA-identical cadaveric kidney transplant

- Age greater or equal to 12 years

Exclusion Criteria:

- Recipient or donor is known seropositive for human immunodeficiency virus (HIV)

- Has current malignancy or history of malignancy

- Has significant liver disease

- Has uncontrolled concomitant infection or any other unstable medical condition

- Is receiving everolimus or enteric coated mycophenolic acid at any time during the

study

- Received kidney with a cold ischemia time of equal or more than 36 hours

- Received kidney transplant from a cadaveric donor equal or more than 60 years of age

- Received intravenous immunoglobulin (IVIG) therapy prior to randomization

Locations and Contacts

Porto Alegre 90240-520, Brazil

Rio de Janeiro 21041-003, Brazil

Sao Paulo 04013-043, Brazil

Sao Paulo 04038-002, Brazil

Sao Paulo 05465-040, Brazil

Birmingham, Alabama 35294, United States

Mobile, Alabama 36617, United States

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Loma Linda, California 92354, United States

Los Angeles, California 90033, United States

Los Angeles, California 90057, United States

Los Angeles, California 90058, United States

Los Angeles, California 90095-7306, United States

Palo Alto, California 94304, United States

San Diego, California 92103, United States

San Diego, California 92123, United States

San Francisco, California 94115, United States

Denver, Colorado 80262, United States

Washington, District of Columbia 20010, United States

Gainesville, Florida 32610-0224, United States

Jacksonville, Florida 32216, United States

Augusta, Georgia 30912, United States

Chicago, Illinois 60612, United States

Chicago, Illinois 60637, United States

Indianapolis, Indiana 46202, United States

Lexington, Kentucky 40536, United States

New Orleans, Louisiana 70112, United States

New Orleans, Louisiana 70121, United States

Boston, Massachusetts 02214, United States

Ann Arbor, Michigan 48109-0364, United States

Detroit, Michigan 48202, United States

Livingston, New Jersey 07039, United States

New Brunswick, New Jersey 08901, United States

Albany, New York 12208, United States

Buffalo, New York 14203, United States

New York, New York 10029, United States

Valhalla, New York 10595, United States

Chapel Hill, North Carolina 27599-7211, United States

Durham, North Carolina 27710, United States

Cincinnati, Ohio 45267, United States

Toronto, Ontario, Canada

Portland, Oregon 97210, United States

Portland, Oregon 97239-2940, United States

Harrisburg, Pennsylvania 17104, United States

Philadelphia, Pennsylvania 19107, United States

Philadelphia, Pennsylvania 19104, United States

Montreal, Quebec, Canada

Nashville, Tennessee 37212-4750, United States

Dallas, Texas 75235, United States

Dallas, Texas 75246, United States

Houston, Texas 77030, United States

San Antonio, Texas 78229-3900, United States

Salt Lake City, Utah 84132, United States

Fairfax, Virginia 22031, United States

Madison, Wisconsin 53792-7375, United States

Milwaukee, Wisconsin 53226, United States

Additional Information

Related publications:

Silva HT Jr, Yang HC, Abouljoud M, Kuo PC, Wisemandle K, Bhattacharya P, Dhadda S, Holman J, Fitzsimmons W, First MR. One-year results with extended-release tacrolimus/MMF, tacrolimus/MMF and cyclosporine/MMF in de novo kidney transplant recipients. Am J Transplant. 2007 Mar;7(3):595-608. Epub 2007 Jan 11. Erratum in: Am J Transplant. 2007 Jun;7(6):1682.

Starting date: June 2003
Last updated: November 12, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017