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

Sponsor:	University of Miami
Collaborator:	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 Drug: Tacrolimus and mycophenolate mofetil Drug: SRL and TAC Drug: Mycophenolate Mofetil	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Tacrolimus and Mycophenolate Mofetil vs Tacrolimus and Sirolimus in SPK, Pancreas After Kidney or Pancreas Transplant Alone

Resource links provided by NLM:

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	September 2000
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: TAC and MMF and Steroid This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.	Drug: Tacrolimus and mycophenolate mofetil MMF 1 gm BID beginning 1st day postoperative day Other Names: Prograf Cellcept
Active Comparator: TAC and SRL Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.	Drug: Rapamycin Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day. Other Name: Rapamune® (sirolimus) Drug: SRL and TAC Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels: 10-15ng/ml) Other Name: Rapamune Drug: Mycophenolate Mofetil Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.

Arms

Assigned Interventions

Active Comparator: TAC and MMF and Steroid

This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.

Drug: Tacrolimus and mycophenolate mofetil

MMF 1 gm BID beginning 1st day postoperative day

Other Names:

Prograf
Cellcept

Active Comparator: TAC and SRL

Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.

Drug: Rapamycin

Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.

Other Name: Rapamune® (sirolimus)

Drug: SRL and TAC

Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:

10-15ng/ml)

Other Name: Rapamune

Drug: Mycophenolate Mofetil

Patients randomized to receive 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:

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.

Responsible Party:	George Burke, University of Miami
ClinicalTrials.gov Identifier:	NCT00533442 History of Changes
Other Study ID Numbers:	UM-IRB # 2000-176
Study First Received:	September 19, 2007
Last Updated:	March 25, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Miami:

Rapamycin
Mycophenolate mofetil
kidney-pancreas transplant

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pancrelipase
Sirolimus
Mycophenolic Acid
Everolimus
Mycophenolate mofetil
Tacrolimus

Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012