Prophylaxis With Ganciclovir Improves Graft Survival in Renal Allograft Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2003-10-31

Brief Summary

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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.

Detailed Description

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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 life-threatening disease. CMV can cause a variety of symptoms in the immunocompromised host, including CMV retinitis, pneumonia or colitis. After grafting, CMV disease most commonly occurs in the transplanted organ and can trigger graft dysfunction and acute rejection. Therefore, prophylaxis or preemptive therapy should be used in order to prevent graft recipients from CMV disease.

* CMV prophylaxis means the administration of antiviral agents to all patients at risk for CMV disease, directly after transplantation, i.e. for 3 months. Prophylaxis is in particular used for patients at high risk for CMV disease.
* CMV preemptive therapy (or targeted prophylaxis) means CMV monitoring and initiation of induction therapy with antiviral agents in patients with proven CMV viral load only (CMV infection). This prevents non-infected patients from being exposed to antiviral drugs and the related side effects like neutropenia or renal toxicity. Preemptive therapy is in particular used for patients at lower or moderate risk for CMV disease.

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.

Conditions

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DNA Virus Infection Herpesviridae Infections Cytomegalovirus Infection

Keywords

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Renal Transplantation CMV Ganciclovir Prophylaxis Preemptive Therapy Graft Survival Proteomics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Ganciclovir

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Volker Kliem, MD

Role: STUDY_CHAIR

Lower Saxony Center for Nephrology, Transplantation Center, Department of Nephrology

References

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Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.

Reference Type DERIVED

PMID: 39807668 (View on PubMed)

Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.