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Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Rapamycin

Mycophenolate Mofetil

Tacrolimus

Steroids

About this trial

This is an interventional prevention trial for Type 1 Diabetes focused on measuring Rapamycin, Mycophenolate Mofetil (MMF), Kidney-Pancreas Transplant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

University of Miami, Miller School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tacrolimus plus MMF plus Steroids

Tacrolimus plus Rapamycin plus Steroids

Arm 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.

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.

Outcomes

Primary Outcome Measures

Event-Specific Survival Comparisons

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.

Secondary Outcome Measures

Overall Kidney Transplant Function at 12, 36, and 60 Months 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.

Comparisons of pancreas function (C-peptide in ng/mL) at 12, 36, and 60 months post-transplant.

Full Information

NCT ID

NCT00533442

First Posted

September 19, 2007

Last Updated

June 12, 2017

Sponsor

University of Miami

Collaborators

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT00533442

Brief Title

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

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

September 2000 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

Collaborators

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

Rapamycin, Mycophenolate Mofetil (MMF), Kidney-Pancreas Transplant

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

170 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tacrolimus plus MMF plus Steroids

Arm Type

Active Comparator

Arm Description

Arm Title

Tacrolimus plus Rapamycin plus Steroids

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Rapamycin

Other Intervention Name(s)

Rapamune® (sirolimus)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Mycophenolate Mofetil

Other Intervention Name(s)

Cellcept, MMF

Intervention Description

MMF 1 gm BID beginning 1st day postoperative day

Intervention Type

Drug

Intervention Name(s)

Tacrolimus

Other Intervention Name(s)

TAC

Intervention Description

Part of standard maintenance.

Intervention Type

Drug

Intervention Name(s)

Steroids

Other Intervention Name(s)

Corticosteroids

Intervention Description

Part of standard maintenance

Primary Outcome Measure Information:

Title

Event-Specific Survival Comparisons

Description

Time Frame

over 1-10 years post-transplant

Secondary Outcome Measure Information:

Title

Overall Kidney Transplant Function at 12, 36, and 60 Months Post-transplant.

Description

Comparisons of renal function (eGFR, measured in mL/min/1.73 m^2) at 12, 36, and 60 months post-transplant.

Time Frame

at 1-5 years post-transplant

Title

Overall Pancreas Transplant Function at 12, 36, and 60 Months Post-transplant.

Description

Comparisons of pancreas function (C-peptide in ng/mL) at 12, 36, and 60 months post-transplant.

Time Frame

at 1-5 years post-transplant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George W Burke, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami, Miller School of Medicine

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12176628

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.

Results Reference

result

PubMed Identifier

12176626

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.

Results Reference

result

PubMed Identifier

15233820

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.

Results Reference

result

PubMed Identifier

22946986

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.

Results Reference

result

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Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

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