Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

University of Miami

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes

Treatments: Drug: Mycophenolate Mofetil; Drug: Tacrolimus; Drug: Rapamycin; Drug: Steroids

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00533442

20000176

Details and patient eligibility

About

This study was designed to determine which maintenance 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.

Full description

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

Enrollment: 170 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Tacrolimus plus MMF plus Steroids

Active Comparator group

Description:

Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Mycophenolate Mofetil (MMF), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.

Treatment:

Drug: Steroids

Drug: Tacrolimus

Drug: Mycophenolate Mofetil

Tacrolimus plus Rapamycin plus Steroids

Experimental group

Description:

Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Rapamycin (Sirolimus), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.

Treatment:

Drug: Steroids

Drug: Rapamycin

Drug: Tacrolimus