Prophylaxis With Ganciclovir Improves Graft Survival in Renal Allograft Recipients

NCT00373165 | Completed Phase 4

• 1 other identifier: ML19827
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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. 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

DNA Virus Infection; Herpesviridae Infections; Cytomegalovirus Infection

Keywords

Renal Transplantation; CMV; Ganciclovir; Prophylaxis; Preemptive Therapy; Graft Survival; Proteomics

Outcome Measures

Primary Outcomes (1)

• The impact of CMV infection on graft function, incidence of CMV infection and creatinine clearance in both study groups at month 12. long-term graft and patient survival. Neutrophil counts and creatinine clearance were measured on a regular basis.

Interventions

Ganciclovir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lower Saxony Center for Nephrology: lead

Related Publications (2)

• 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.

  PMID: 39807668 DERIVED

• 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.

  PMID: 38700045 DERIVED

MeSH Terms

Conditions

DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections; Multiple Acyl Coenzyme A Dehydrogenase Deficiency

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

Virus Diseases; Infections; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Mitochondrial Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Volker Kliem, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 7, 2006
• Study Start: August 1, 2000
• Study Completion: October 1, 2003
• Last Updated: September 13, 2006

Record last verified: 2006-09