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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.
Information provided by (Responsible Party):
Stephan Busque, Stanford University Identifier:
First received: February 22, 2006
Last updated: November 29, 2016
Last verified: November 2016

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
Intervention Model: Parallel Assignment
Masking: None (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 Stephan Busque, Stanford University:

Primary Outcome Measures:
  • Primary Endpoints: [ Time Frame: 1 year ]
    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 ]
    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 ]
    assessment of oral hypoglycemic agents

  • Insulin requirements. [ Time Frame: 1 year ]
    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 ]
    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 ]
    metabolic assessment

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

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

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

  • Infection rate [ Time Frame: 1 year ]
    as clinically significant

  • Re-admission related to diabetes complication [ Time Frame: 1 year ]
    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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00296296

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


Responsible Party: Stephan Busque, Principle Investigator, Stanford University Identifier: NCT00296296     History of Changes
Other Study ID Numbers: 95442
Study First Received: February 22, 2006
Last Updated: November 29, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Stephan Busque, Stanford University:
kidney Transplant
Type II Diabetes
Diabetic Nephropathy

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
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 processed this record on September 19, 2017