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Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

This study is ongoing, but not recruiting participants.
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: May 6, 2014
Last verified: May 2014

September 19, 2007
May 6, 2014
September 2000
May 2015   (final data collection date for primary outcome measure)
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 ]
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
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 ]
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 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 drugs above.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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: Tacrolimus and mycophenolate mofetil
    MMF 1 gm BID beginning 1st day postoperative day
    Other Names:
    • Prograf
    • Cellcept
  • Drug: Rapamune and Tacrolimus

    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.
  • Active Comparator: TAC and MMF and Steroid
    This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.
    Intervention: Drug: Tacrolimus and mycophenolate mofetil
  • Active Comparator: tacrolimus and rapamune
    Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.
    Interventions:
    • Drug: Rapamycin
    • Drug: Rapamune and Tacrolimus
    • Drug: Mycophenolate Mofetil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
190
May 2015
May 2015   (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).
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00533442
UM-IRB # 2000-176
No
George W. Burke, University of Miami
University of Miami
Astellas Pharma Inc
Principal Investigator: George W Burke, MD University of Miami
University of Miami
May 2014

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