Status:
COMPLETED
Prophylaxis With Ganciclovir Improves Graft Survival in Renal Allograft Recipients
Lead Sponsor:
Lower Saxony Center for Nephrology
Conditions:
DNA Virus Infection
Herpesviridae Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Study Phase: IV Study Type: Open-label, multicenter, randomised clinical trial with two arms stratified for an intensified immunosuppressive regimen in patients at high risk for acute rejection. Stu...
Detailed Description
Disease Background: More than 60 % of adult people are asymptomatically infected with cytomegalovirus (CMV). Due to immunosuppressive therapy, renal graft recipients are at risk for CMV infection and ...
Eligibility Criteria
Inclusion
- Kidney transplant recipients after living or postmortal donation
- CMV seropositive donor or recipient of the kidney transplant: D+/R-, D+/R+ or D-/R+
- Laboratory parameters: 50.000/ml thrombocytes and/or 1000/ml neutrophils
- Immunosuppression including MMF
- Main
Exclusion
- Woman who are pregnant, breastfeeding or using unreliable birth control methods
- Forbidden concomitant medications during the 12 month observation period of the study are:
- Virustatic drugs, active against CMV: Foscarnet, Cidofovir (HPMPC), Acyclovir, Valaciclovir, Famciclovir/Penciclovir, Lobucavir, Antisense compound
- Antimetabolites: Fluorouracil, Mercaptopurine, Methotrexate, Thioguanine, Hydroxurea
- Alkylating substances: Busulfan, Carmustine, Chlorambucil, Cisplatin, Cyclophosphamide, Dacarbazine (DTIC), Lomustine, Mechlormethamine, Melphalan, Streptozotocin, Tiothepa, Uracil mustard
- anti CMV immunoglobulins (except in the case of signs of CMV infection) such as anti CMV hyperimmunoglobulins and immunoglobulins
- Known hypersensitivity to ganciclovir
- Patients with active CMV infection or positive viraemia at randomization
- Severe gastro-intestinal diseases which may interfere with the oral resorption of ganciclovir
- Conversion of immunosuppression (Replacement of MMF)
- Participation in another clinical drug trial
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
End Date :
October 1 2003
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00373165
Start Date
August 1 2000
End Date
October 1 2003
Last Update
September 13 2006
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