Prophylaxis With Ganciclovir Improves Graft Survival in Renal Allograft Recipients

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

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.

Study Description: 148 kidney transplant recipients at risk for CMV disease were randomized and treated with ganciclovir capsules for 3 months (Group A, prophylaxis, N=74) or received ganciclovir IV only in case of proven CMV viral load (Group B, preemptive therapy, N=74). Initially, a 2 months follow up was planned in this trial. However, the study group decided to offer a longterm follow up to all patients and amended the protocol, respectively.

The aim of the study was to identify the most efficacious way to prevent renal transplant recipients from CMV disease and to find out, if one of these two strategies may increase graft or patient survival. Therefore, both wellknown approaches of CMV prevention were compared in two study groups:

Prophylaxis (Group A): Oral primary prophylaxis with ganciclovir capsules was started directly after transplantation and performed until day 90. In case of CMV infection (proven CMV viral load) or symptomatic CMV disease, treatment with ganciclovir IV was initiated.

Preemptive Therapy (Group B): No oral primary prophylaxis was given. Treatment with ganciclovir IV was given to patients with proven CMV viral load (CMV infection or CMV disease) only.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lower Saxony Center for Nephrology
• Treatments: Ganciclovir; Ganciclovir triphosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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