NCT00533442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 12, 2017

Completed
Last Updated

July 12, 2017

Status Verified

June 1, 2017

Enrollment Period

15.7 years

First QC Date

September 19, 2007

Results QC Date

March 6, 2017

Last Update Submit

June 12, 2017

Conditions

Type 1 Diabetes

Keywords

RapamycinMycophenolate Mofetil (MMF)Kidney-Pancreas Transplant

Outcome Measures

Primary Outcomes (1)

  • 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.

    over 1-10 years post-transplant

Secondary Outcomes (2)

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

    at 1-5 years post-transplant

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

    at 1-5 years post-transplant

Study Arms (2)

Tacrolimus plus MMF plus Steroids

ACTIVE COMPARATOR

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.

Drug: Mycophenolate MofetilDrug: TacrolimusDrug: Steroids

Tacrolimus plus Rapamycin plus Steroids

EXPERIMENTAL

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.

Drug: RapamycinDrug: TacrolimusDrug: Steroids

Interventions

RapamycinDRUG

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.

Also known as: Rapamune® (sirolimus)
Tacrolimus plus Rapamycin plus Steroids
Mycophenolate MofetilDRUG

MMF 1 gm BID beginning 1st day postoperative day

Also known as: Cellcept, MMF
Tacrolimus plus MMF plus Steroids
TacrolimusDRUG

Part of standard maintenance.

Also known as: TAC
Tacrolimus plus MMF plus SteroidsTacrolimus plus Rapamycin plus Steroids
SteroidsDRUG

Part of standard maintenance

Also known as: Corticosteroids
Tacrolimus plus MMF plus SteroidsTacrolimus plus Rapamycin plus Steroids

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami, Miller School of Medicine

Miami, Florida, 33136, United States

Location

Related Publications (4)

  • 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.

    PMID: 12176628RESULT

  • 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.

    PMID: 12176626RESULT

  • 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.

    PMID: 15233820RESULT

  • 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.

    PMID: 22946986RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

SirolimusMycophenolic AcidTacrolimusSteroidsAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsFused-Ring CompoundsPolycyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Dr. George W. Burke, III
Organization
University of Miami
gburke@med.miami.edu
305-355-5111

Study Officials

  • George W Burke, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 21, 2007

Study Start

September 1, 2000

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

July 12, 2017

Results First Posted

July 12, 2017

Record last verified: 2017-06

Locations

US(1)