This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
George W. Burke, University of Miami
ClinicalTrials.gov Identifier:
NCT00533442
First received: September 19, 2007
Last updated: June 12, 2017
Last verified: June 2017
September 19, 2007
June 12, 2017
September 2000
May 2016   (Final data collection date for primary outcome measure)
Event-Specific Survival Comparisons [ Time Frame: over 1-10 years post-transplant ]
Freedom from biopsy-proven acute rejection of the kidney allograft; Freedom from biopsy-proven acute rejection of the pancreas allograft; Death-censored kidney graft survival; Death-censored pancreas graft survival; Death-uncensored graft (kidney and pancreas) survival; and Patient survival.
Freedom from acute rejection; kidney or pancreas transplant loss, and death at one year after transplant. [ Time Frame: one to seven years ]
Complete list of historical versions of study NCT00533442 on ClinicalTrials.gov Archive Site
  • Overall Kidney Transplant Function at 12, 36, and 60 Months Post-transplant. [ Time Frame: at 1-5 years post-transplant ]
    Comparisons of renal function (eGFR, measured in mL/min/1.73 m^2) at 12, 36, and 60 months post-transplant.
  • Overall Pancreas Transplant Function at 12, 36, and 60 Months Post-transplant. [ Time Frame: at 1-5 years post-transplant ]
    Comparisons of pancreas function (C-peptide in ng/mL) at 12, 36, and 60 months post-transplant.
12 month safety and efficacy assessments including side effects and overall kidney and pancreas transplant function. [ Time Frame: one to seven years ]
Not Provided
Not Provided
 
Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients
Tacrolimus and Mycophenolate Mofetil vs Tacrolimus and Sirolimus in SPK, Pancreas After Kidney or Pancreas Transplant Alone
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.
This is a randomized, prospective single center study evaluating the two maintenance drugs above.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Type 1 Diabetes
  • 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: Mycophenolate Mofetil
    MMF 1 gm BID beginning 1st day postoperative day
    Other Names:
    • Cellcept
    • MMF
  • Drug: Tacrolimus
    Part of standard maintenance.
    Other Name: TAC
  • Drug: Steroids
    Part of standard maintenance
    Other Name: Corticosteroids
  • Active Comparator: Tacrolimus plus MMF plus Steroids
    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.
    Interventions:
    • Drug: Mycophenolate Mofetil
    • Drug: Tacrolimus
    • Drug: Steroids
  • Experimental: Tacrolimus plus Rapamycin plus Steroids
    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.
    Interventions:
    • Drug: Rapamycin
    • Drug: Tacrolimus
    • Drug: Steroids

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
May 2016
May 2016   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00533442
20000176
No
Not Provided
Not Provided
George W. Burke, University of Miami
University of Miami
Astellas Pharma Inc
Principal Investigator: George W Burke, MD University of Miami
University of Miami
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP