Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

Type 1 Diabetes Clinical Trial

Official title:

Tacrolimus and Mycophenolate Mofetil vs Tacrolimus and Sirolimus in SPK, Pancreas After Kidney or Pancreas Transplant Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533442
• Other study ID #: 20000176
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2007
• Last updated: June 2, 2016
• Start date: September 2000
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

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.
• Tacrolimus and mycophenolate mofetil
MMF 1 gm BID beginning 1st day postoperative day
• Rapamune and Tacrolimus
Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels: 10-15ng/ml)
• Mycophenolate Mofetil
Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.

Locations

Country	Name	City	State
United States	University of Miami, Miller School of Medicine	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. 200 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from acute rejection; kidney or pancreas transplant loss, and death at one year after transplant.		one to seven years	Yes
Secondary	12 month safety and efficacy assessments including side effects and overall kidney and pancreas transplant function.		one to seven years	Yes