Clinical trial NCT00533442: Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients
Official title: Tacrolimus and Mycophenolate Mofetil vs Tacrolimus and Sirolimus in SPK, Pancreas After Kidney or Pancreas Transplant Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: Rapamycin
Mycophenolate Mofetil (MMF)
Kidney-Pancreas Transplant
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2007-09-21
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility 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).

Primary outcomes:
measure: Event-Specific Survival Comparisons
timeFrame: over 1-10 years post-transplant
Secondary outcomes:
measure: Overall Kidney Transplant Function at 12, 36, and 60 Months Post-transplant.
timeFrame: at 1-5 years post-transplant
measure: Overall Pancreas Transplant Function at 12, 36, and 60 Months Post-transplant.
timeFrame: at 1-5 years post-transplant
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami, Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: George W Burke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/s0041-1345(02)03122-6. No abstract available.
citation: Burke G 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. doi: 10.1016/s0041-1345(02)03149-4. No abstract available.
citation: 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. doi: 10.1111/j.1399-0012.2004.00183.x.
citation: Ciancio G, Sageshima J, Chen L, Gaynor JJ, Hanson L, Tueros L, Montenora-Velarde E, Gomez C, Kupin W, Guerra G, Mattiazzi A, Fornoni A, Pugliese A, Roth D, Wolf M, Burke GW 3rd. Advantage of rapamycin over mycophenolate mofetil when used with tacrolimus for simultaneous pancreas kidney transplants: randomized, single-center trial at 10 years. Am J Transplant. 2012 Dec;12(12):3363-76. doi: 10.1111/j.1600-6143.2012.04235.x. Epub 2012 Sep 4.