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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00296296
First received: February 22, 2006
Last updated: January 23, 2007
Last verified: January 2007
  Purpose

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

PURPOSE This is a single center medical research study to analyze post-transplant kidney recipients with pre-existing (prior to transplantation) type 2 diabetes managed according to the recommended American Diabetes Association (ADA) guidelines. Prograf (Tacrolimus) and Neoral (Cyclosporin) 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). Prednisone can worsen diabetes.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Open Label Study Comparing the Metabolic Control of First Kidney Transplant Recipients With Pre-Existing Type 2 Diabetes (DM) Receiving Either Prograf or Neoral as Part of a Thymoglobulin Induction, Prednisone Free and Blood Monitored Cellcept Immunosuppressive Drug Regimen.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Primary Endpoints:
  • Maintenance of glucose metabolism within the ADA criteria without usage of insulin at 3, 6 and 12 months after kidney transplantation.
  • Number of class of oral agents required to maintain glycemic control within the ADA criteria at 3, 6 and 12 months after kidney transplantation
  • Insulin requirements.

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.
  • Lipid metabolism, change in BMI and waist measurements at 3, 6 and 12 months after kidney transplantation.
  • Patient and graft survival at one year post transplantation)
  • Incidence of biopsy proven acute rejection at 6 month post transplantation
  • Kidney function at one year (creatinine clearance and proteinuria)
  • Infection rate
  • Re-admission related to diabetes complication

Estimated Enrollment: 40
Study Start Date: June 2005
Estimated Study Completion Date: October 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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

Contacts
Contact: Stephan Busque, MD 650-498-6189 sbsuque@stanford.edu
Contact: Anna Simos, MPH, CDE 650-498-4526 asimos@stanford.edu

Locations
United States, California
Stanford university Hospital and Clinics Recruiting
Stanford, California, United States, 94305
Principal Investigator: Stephan Busque, MD         
Sub-Investigator: Andrew Bonham, MD         
Sub-Investigator: Richard Lafayette, MD         
Sub-Investigator: Tracey McLaughlin, MD         
Sub-Investigator: Maria Millan, MD         
Sub-Investigator: John Scandling, MD         
Sub-Investigator: Jane Tan, M.D., PhD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Stephan Busque, MD Stanford University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00296296     History of Changes
Other Study ID Numbers: 95442
Study First Received: February 22, 2006
Last Updated: January 23, 2007
Health Authority: United States: Food and Drug Administration

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
Cyclosporins
Cyclosporine
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014