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

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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Diabetic Kidney Problems Kidney Transplantation Steroids

Drug Information available for: Cyclosporine Tacrolimus

U.S. FDA Resources

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

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

Exclusion Criteria

Recipients of a transplant graft from a donor age 65 and older.
Recipient of a multi-organ transplant.
Patients who are being re-transplanted will not be eligible for study.
Patients who have lost a previous graft to rejection less than one year from transplant.
Patient has any form of substance abuse, psychiatric disorder, or a condition in the opinion of the investigator, may invalidate communication with the investigator.
PRA > 30%

Contacts and Locations

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:

Weir MR, Fink JC. Risk for posttransplant Diabetes mellitus with current immunosuppressive medications. Am J Kidney Dis. 1999 Jul;34(1):1-13. Review.

Sarwal MM, Yorgin PD, Alexander S, Millan MT, Belson A, Belanger N, Granucci L, Major C, Costaglio C, Sanchez J, Orlandi P, Salvatierra O Jr. Promising early outcomes with a novel, complete steroid avoidance immunosuppression protocol in pediatric renal transplantation. Transplantation. 2001 Jul 15;72(1):13-21.

Rigatto C. Clinical epidemiology of cardiac disease in renal transplant recipients. Semin Dial. 2003 Mar-Apr;16(2):106-10. Review.

Hamar P, Muller V, Kohnle M, Witzke O, Albrecht KH, Philipp T, Heemann U. Metabolic factors have a major impact on kidney allograft survival. Transplantation. 1997 Oct 27;64(8):1135-9.

Maes BD, Kuypers D, Messiaen T, Evenepoel P, Mathieu C, Coosemans W, Pirenne J, Vanrenterghem YF. Posttransplantation diabetes mellitus in FK-506-treated renal transplant recipients: analysis of incidence and risk factors. Transplantation. 2001 Nov 27;72(10):1655-61.

Revanur VK, Jardine AG, Kingsmore DB, Jaques BC, Hamilton DH, Jindal RM. Influence of diabetes mellitus on patient and graft survival in recipients of kidney transplantation. Clin Transplant. 2001 Apr;15(2):89-94.

Gerber JC, Stewart DL. Prevention and control of hypertension and diabetes in an underserved population through community outreach and disease management: a plan of action. J Assoc Acad Minor Phys. 1998;9(3):48-52.

Navasa M, Bustamante J, Marroni C, Gonzalez E, Andreu H, Esmatjes E, Garcia-Valdecasas JC, Grande L, Cirera I, Rimola A, Rodes J. Diabetes mellitus after liver transplantation: prevalence and predictive factors. J Hepatol. 1996 Jul;25(1):64-71.

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
Diabetic Nephropathies
Kidney Diseases
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 May 21, 2013