Status:
COMPLETED
Impact of Immunosuppressive Regimens on Polyomavirus-related Transplant Nephropathy
Lead Sponsor:
University of Giessen
Collaborating Sponsors:
Heidelberg University
Hoffmann-La Roche
Conditions:
Polyomavirus Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to characterize and evaluate risk factors of polyomavirus nephropathy (PVN) including the impact of three immunosuppressive regimens.
Detailed Description
Polyomavirus nephropathy (PVN) is an emerging cause of renal transplant loss. Until now the risk factors of PVN are poorly understood. Tacrolimus (Tacr) and mycophenolate mofetil (MMF) are thought to ...
Eligibility Criteria
Inclusion
- Cadaver kidney and living donor kidney transplant recipients
- Primary, secondary, and tertiary transplant recipients
- Pre-immunized and not pre-immunized transplant recipients
- Age \> 18 years
Exclusion
- Contraindications against administration of one of the four study drugs
- History of severe gastrointestinal morbidity
- Age \< 18 years
- Pregnant or breast feeding women
- Rejection of effective contraceptive methods with young women
- Combined kidney and islet cell transplantation
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00160966
Start Date
September 1 2004
End Date
March 1 2010
Last Update
March 28 2017
Active Locations (1)
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1
Department of Internal Medicine, University of Giessen
Giessen, Germany, 35392