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Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephan Busque, Stanford University
ClinicalTrials.gov Identifier:
NCT00296296
First received: February 22, 2006
Last updated: November 29, 2016
Last verified: November 2016
  Purpose

Protocol Title: Randomized open label study comparing the metabolic control of first Kidney Transplant recipients with Type 2 Diabetes Mellitus (DM) receiving either Prograf or Neoral as part of a ATG induction, prednisone free and blood monitored Cellcept immunosuppressive regimen.

PURPOSE This is a single center medical research study to analyze post-transplant kidney recipients with pre-existing type 2 diabetes managed according to the recommended American Diabetes Association (ADA) guidelines. Prograf (Tac) and Neoral (CSA) are the two main medications to prevent rejection after transplantation. However, they may contribute to poorer diabetes control. The purpose of the study is to compare the effects of Prograf and Neoral on the control of Diabetes after kidney transplantation. In addition, all participants in this study will receive Thymoglobulin (anti-lymphocyte globulin) at the time of transplantation instead of long term prednisone (steroids).


Condition Intervention Phase
Kidney Transplant
Diabetes Mellitus, Type 2
Diabetic Nephropathy
Drug: Cyclosporin
Drug: Tacrolimus
Behavioral: 'Diabetes Education / Management'
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Open Label Study Comparing the Metabolic Control of Kidney Transplant Recipients With Type 2 Diabetes Receiving Either Prograf or Neoral as Part of a ATG Induction, Prednisone Free and Monitored MMF Immunosuppressive Regimen.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Primary Endpoints: [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    freedom from insulin therapy

  • Maintenance of glucose metabolism within the ADA criteria without usage of insulin at 3, 6, and 12 months after kidney transplantation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    based on monitoring of glycemia

  • Number of class of oral agents required to maintain glycemic control within the ADA criteria at 3, 6 and 12 months after kidney transplantation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    assessment of oral hypoglycemic agents

  • Insulin requirements. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    average daily use


Secondary Outcome Measures:
  • Markers of glucose tolerance and insulin secretion (OGTT, C-peptide, insulin levels, Glycosylated hemoglobin, fructosamine) at 3, 6 and 12 months after kidney transplantation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    as measure post glucose load

  • Lipid metabolism, change in BMI and waist measurements at 3, 6 and 12 months after kidney transplantation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    metabolic assessment

  • Patient and graft survival at one year post transplantation) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    as observed

  • Incidence of biopsy proven acute rejection at 6 month post transplantation [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    as clinically indicated

  • Kidney function at one year (creatinine clearance and proteinuria) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    as measured

  • Infection rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    as clinically significant

  • Re-admission related to diabetes complication [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    as detected


Enrollment: 29
Study Start Date: June 2005
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cyclosporin
Patients receive cyclosporin as immunossupressive CNI 'Diabetes Education / Management'
Drug: Cyclosporin
Dose adjustment to pre-established targets
Other Name: neoral
Behavioral: 'Diabetes Education / Management'
therapeutic adjustment to target ADA criteria
Active Comparator: Tacrolimus
Patients receive tacrolimus as immunosuppressive CNI 'Diabetes Education / Management'
Drug: Tacrolimus
Dose adjustment to pre-established targets
Other Name: prograf
Behavioral: 'Diabetes Education / Management'
therapeutic adjustment to target ADA criteria

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria

  1. Patient is a recipient of a first cadaveric kidney, or a kidney living donor mismatched (at least one mismatch.)
  2. Patient is a minimum of 18 years of age at the time of transplant.
  3. Patient has type 2 non-insulin dependent diabetes.
  4. Patient or legal guardian has signed and dated an Ethics Committee-approved informed consent document and is willing and able to follow study procedures.
  5. If female and is childbearing potential, patient has a negative pregnancy test and utilizes adequate contraceptive methods.

Exclusion Criteria

  1. Recipients of a transplant graft from a donor age 65 and older.
  2. Recipient of a multi-organ transplant.
  3. Patients who are being re-transplanted will not be eligible for study.
  4. Patients who have lost a previous graft to rejection less than one year from transplant.
  5. Patient has any form of substance abuse, psychiatric disorder, or a condition in the opinion of the investigator, may invalidate communication with the investigator.
  6. PRA > 30%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296296

Locations
United States, California
Stanford university Hospital and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Stephan Busque, MD Stanford University
  More Information

Publications:

Responsible Party: Stephan Busque, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00296296     History of Changes
Other Study ID Numbers: 95442 
Study First Received: February 22, 2006
Last Updated: November 29, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Stanford University:
kidney Transplant
Type II Diabetes
Diabetic Nephropathy
Immunosuppression
Cyclosporin
Tacrolimus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Tacrolimus
Cyclosporins
Cyclosporine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on December 08, 2016