Status:
COMPLETED
Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM)
Lead Sponsor:
Stanford University
Conditions:
Kidney Transplant
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
Detailed Description
It has been accepted that patients with DM are associated with a greater risk of morbidity and mortality and hyperlipidemia, compromised graft function, stroke, nephropathy, atherosclerotic cardiovasc...
Eligibility Criteria
Inclusion
- 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%
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00296296
Start Date
June 1 2005
End Date
October 1 2014
Last Update
October 6 2017
Active Locations (1)
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1
Stanford university Hospital and Clinics
Stanford, California, United States, 94305