Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM)
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.
1 other identifier
interventional
29
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2005
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 22, 2006
CompletedFirst Posted
Study publicly available on registry
February 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
October 6, 2017
CompletedOctober 6, 2017
October 1, 2017
9.3 years
February 22, 2006
September 6, 2017
October 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Freedom From Insulin Therapy Post Transplant
The count of participants with freedom from insulin therapy post transplant is reported.
From hospital discharge to 1 year post-transplant
Estimated Glomerular Filtration Rate (eGFR) 1 Year Following 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.
1 year post-transplantation
Secondary Outcomes (2)
Patient Survival at One Year Post Transplantation
Up to 1 year post-transplantation
Count of Participants With Biopsy Proven Acute Rejection at One Year Post Transplantation
1 year post-transplantation
Study Arms (2)
Cyclosporin
ACTIVE COMPARATORPatients 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)
Tacrolimus
ACTIVE COMPARATORPatients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
Interventions
therapeutic adjustment to target ADA criteria
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford university Hospital and Clinics
Stanford, California, 94305, United States
Related Publications (8)
Weir MR, Fink JC. Risk for posttransplant Diabetes mellitus with current immunosuppressive medications. Am J Kidney Dis. 1999 Jul;34(1):1-13. doi: 10.1016/s0272-6386(99)70101-0.
PMID: 10401009BACKGROUNDSarwal 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. doi: 10.1097/00007890-200107150-00006.
PMID: 11468528BACKGROUNDRigatto C. Clinical epidemiology of cardiac disease in renal transplant recipients. Semin Dial. 2003 Mar-Apr;16(2):106-10. doi: 10.1046/j.1525-139x.2003.16026.x.
PMID: 12641873BACKGROUNDHamar 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. doi: 10.1097/00007890-199710270-00009.
PMID: 9355829BACKGROUNDMaes 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. doi: 10.1097/00007890-200111270-00014.
PMID: 11726827BACKGROUNDRevanur 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. doi: 10.1034/j.1399-0012.2001.150202.x.
PMID: 11264633BACKGROUNDGerber 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.
PMID: 9747058BACKGROUNDNavasa 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. doi: 10.1016/s0168-8278(96)80329-1.
PMID: 8836903BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stephan Busque, MD
- Organization
- Stanford University
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan Busque, MD
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
February 22, 2006
First Posted
February 24, 2006
Study Start
June 1, 2005
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
October 6, 2017
Results First Posted
October 6, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share