We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00296296
Recruitment Status : Completed
First Posted : February 24, 2006
Results First Posted : October 6, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
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.
Study Start Date : June 2005
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Cyclosporin
Patients receive cyclosporin (dose-adjusted to pre-established targets) as immunosuppressive calcineurin inhibitor (CNI) and Diabetes Education / Management (therapeutic adjustment to target American Diabetes Association (ADA) criteria)
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 (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
Drug: Tacrolimus
Dose adjustment to pre-established targets
Other Name: Prograf
Behavioral: 'Diabetes Education / Management'
therapeutic adjustment to target ADA criteria


Outcome Measures

Primary Outcome Measures :
  1. Freedom From Insulin Therapy Post Transplant [ Time Frame: From hospital discharge to 1 year post-transplant ]
    The count of participants with freedom from insulin therapy post transplant is reported.

  2. Estimated Glomerular Filtration Rate (eGFR) 1 Year Following Transplantation [ Time Frame: 1 year post-transplantation ]
    Values of ≥60 ml/min/1.73 m^2 are considered optimal; ≥30-59 ml/min/1.73 m^2 are indicative of successful graft function; lower values are indicative or graft dysfunction.


Secondary Outcome Measures :
  1. Patient Survival at One Year Post Transplantation [ Time Frame: Up to 1 year post-transplantation ]
    Count of participants alive at one year post transplantation

  2. Count of Participants With Biopsy Proven Acute Rejection at One Year Post Transplantation [ Time Frame: 1 year post-transplantation ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: February 24, 2006    Key Record Dates
Results First Posted: October 6, 2017
Last Update Posted: October 6, 2017
Last Verified: October 2017
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
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