Status:
TERMINATED
Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation
Lead Sponsor:
Armando Torres Ramírez
Conditions:
Diabetes Mellitus, Adult-Onset
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. Cyclosporine (CsA) and Tacrolimus are the basis of modern ...
Detailed Description
New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. CsA and Tacrolimus are the basis of modern immunosuppressi...
Eligibility Criteria
Inclusion
- Primary renal transplant recipients with end stage renal disease
- No prior history of diabetes mellitus before transplant
- Absence of Immunologic risk defined by the investigator criterion and Panel Reactive Antibody (PRA) \< 50%
- Absence of severe infection and hepatitis C or B infection
- Efficient contraception in women during the study
- Additionally must meet one of these "Metabolic Criteria
- Recipient age \>or =60 or
- Recipient age between 45 and 59 years and at least one of the following metabolic criteria: Prior to transplantation Triglycerides (TGS) \>200mg/dl or the combination of a body mass index (BMI)\> 27 and Triglycerides\>150 mg/dl or the combination of HDL-cholesterol\<40 mg/dl for men or \<50 mg/dl for women and Triglycerides \>150 mg/dl.
Exclusion
- Patients with type I or II diabetes prior to transplantation defined by the American Diabetes Association (ADA) criteria
- Recipient age under 45
- Patients receiving a second renal transplant
- Patients with high immunological risk or PRA (panel reactive antibody level) \>or =50%
- Severe infection or hepatitis C or B infection.
- Dual renal transplant or double transplant with any other organ.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT01002339
Start Date
February 1 2010
End Date
June 1 2015
Last Update
October 22 2024
Active Locations (10)
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1
Antonio Osuna
Granada, Andalusia, Spain, 18014
2
Domingo Hernández
Málaga, Andalusia, Spain, 29010
3
Carlos Gómez Alamillo
Santander, Cantabria, Spain, 39008
4
Juan Manuel Díaz
Barcelona, Catalonia, Spain, 08025