Rapamycin vs Mycophenolate Mofetil in Kidney-Pancreas Recipients - Full Text View

Sponsors and Collaborators:	University of Miami Astellas Pharma Inc
Information provided by:	University of Miami
ClinicalTrials.gov Identifier:	NCT00533442

Purpose

This study was designed to determine which immunosuppressive agent, rapamycin or mycophenalate mofetil, resulted in better outcome in patients with type 1 diabetes and renal failure, who presented for a kidney-pancreas transplant.

Condition	Intervention	Phase
Type 1 Diabetes	Drug: Rapamycin vs Mycophenolate Mofetil	Phase II

MedlinePlus related topics: Diabetes Diabetes Type 1 Pancreas Transplantation

Drug Information available for: Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Sirolimus Tacrolimus anhydrous Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Tacrolimus and Mycophenolate Mofetil vs Tacrolimus and Sirolimus in SPK, Pancreas After Kidney or Pancreas Transplant Alone

Further study details as provided by University of Miami:

Primary Outcome Measures:

Freedom from acute rejection;kidney or pancreas transplant loss, and death at one year after transplant. [ Time Frame: one to seven years ]

Secondary Outcome Measures:

12 month safety and efficacy assessments including side effects and overall kidney and pancreas transplant function. [ Time Frame: one to seven years ]

Estimated Enrollment:	200
Study Start Date:	September 2000
Estimated Study Completion Date:	August 2012

Arms	Assigned Interventions
1: Active Comparator This group of kidney-pancreas recipients was randomized to receive rapamycin after transplantation.	Drug: Rapamycin vs Mycophenolate Mofetil Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to recive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.
2: Active Comparator Patients randomized to this arm received mycophenolate mofetil, after kidney-pancreas transplantation.	Drug: Rapamycin vs Mycophenolate Mofetil Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to recive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.

Detailed Description:

This is a randomized, prospective single center study evaluating the two drugs above.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient with Type 1 diabetes and end stage renal disease.
Women of childbearing potential must have had a negative pregnancy test (serum or urine).
Patient agrees to participate in the study and sign an informed consent.
Patient has no known contraindication to the administration of rapamycin or mycophenolate mofetil.
Patient has no history of hypersensitivity to rapamycin or mycophenolate mofetil.

Exclusion Criteria:

Patient has history of a malignancy within two years, with the exception of adequately treated localized squamous or basal cell carcinoma of the skin without evidence of recurrence.
Patient is currently abusing drugs or alcohol.
Patient is known or suspected to have an active infection or be seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) or human immunodeficiency virus (HIV).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533442

Contacts

Contact: George W Burke, MD

305-355-5111

gburke@med.miami.edu

Locations

United States, Florida
University of Miami, Miller School of Medicine	Recruiting
Miami, Florida, United States, 33136
Principal Investigator: George W Burke, MD

Sponsors and Collaborators

University of Miami

Astellas Pharma Inc

Investigators

Principal Investigator:

George W Burke, MD

University of Miami,Miller School of Medicine

More Information

Publications of Results:

Burke GW 3rd, Ciancio G, Figueiro J, Olson L, Gomez C, Rosen A, Suzart K, Miller J. Steroid-resistant acute rejection following SPK: importance of maintaining therapeutic dosing in a triple-drug regimen. Transplant Proc. 2002 Aug;34(5):1918-9. No abstract available.

Burke GW 3rd, Ciancio G, Figueiro J, Olson L, Gomez C, Rosen A, Suzart K, Miller J. Can acute rejection be prevented in SPK transplantation? Transplant Proc. 2002 Aug;34(5):1913-4. No abstract available.

Burke GW 3rd, Ciancio G, Figueiro J, Buigas R, Olson L, Roth D, Kupin W, Miller J. Hypercoagulable state associated with kidney-pancreas transplantation. Thromboelastogram-directed anti-coagulation and implications for future therapy. Clin Transplant. 2004 Aug;18(4):423-8.

Study ID Numbers:	UM-IRB # 2000-176
Study First Received:	September 19, 2007
Last Updated:	September 19, 2007
ClinicalTrials.gov Identifier:	NCT00533442
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Miami:

Rapamycin,Mycophenolate mofetil,kidney-pancreas transplant

Study placed in the following topic categories:

Sirolimus
Metabolic Diseases
Autoimmune Diseases
Clotrimazole
Miconazole
Tioconazole
Diabetes Mellitus
Mycophenolic Acid

Endocrine System Diseases
Tacrolimus
Pancrelipase
Diabetes Mellitus, Type 1
Mycophenolate mofetil
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents

Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents

ClinicalTrials.gov processed this record on January 16, 2009