DNA Virus InfectionPhase 4NCT00373165
Prophylaxis With Ganciclovir Improves Graft Survival in Renal Allograft Recipients
A Phase 4 study testing Ganciclovir in people with DNA Virus Infection and Herpesviridae Infections, run by Lower Saxony Center for Nephrology.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DNA Virus Infection, Herpesviridae Infections, Cytomegalovirus Infection
- What is being tested?
- Ganciclovir
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Aug 2000to Oct 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
None listed.
About this study
Official title: Open, Randomised Study Comparing Preemptive Therapy With Intravenous Ganciclovir With and Without Additional Oral Ganciclovir for CMV Prophylaxis in Immunosuppressed Renal Transplant Patients Receiving Monitoring of CMV Viral Load
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.
Read more
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.
Read the 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 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.
- Being tested
- Ganciclovir
- Keywords
- Renal Transplantation, CMV, Ganciclovir, Prophylaxis, Preemptive Therapy, Graft Survival, Proteomics
- Medical subject headings
- DNA Virus Infections, Herpesviridae Infections, Cytomegalovirus Infections, Multiple Acyl Coenzyme A Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanciclovirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startAug 2000
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DNA Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Lower Saxony Center for Nephrology
- Sponsor type
- University, hospital or other
- Investigators
- Volker Kliem, MD, Study chair, Lower Saxony Center for Nephrology, Transplantation Center, Department of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373165
- Sponsor's protocol ID
- ML19827
- Status last verified
- Sep 2006
- First submitted
- 5 Sep 2006
- Last updated
- 13 Sep 2006
- Results posted
- No
Publications
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.
PubMed 39807668Vernooij 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.
PubMed 38700045
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Randomised Study Comparing Preemptive Therapy With Intravenous Ganciclovir With and Without Additional Oral Ganciclovir for CMV Prophylaxis in Immunosuppressed Renal Transplant Patients Receiving Monitoring of CMV Viral Load
- ClinicalTrials.gov ID
- NCT00373165
- Acronym / sponsor ID
- ML19827
- Keywords
- Renal Transplantation, CMV, Ganciclovir, Prophylaxis, Preemptive Therapy, Graft Survival, Proteomics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Lower Saxony Center for NephrologyUniversity, hospital or other
- Study start
- Aug 2000
- Study completion
- Oct 2003
- First posted
- 7 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
- Woman who are pregnant, breastfeeding or using unreliable birth control methods
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ganciclovir | Drug | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2006.
- Derived from this study: PubMed 39807668Vernooij 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.
- Derived from this study: PubMed 38700045Vernooij 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Volker Kliem, MD study chair
Lower Saxony Center for Nephrology, Transplantation Center, Department of Nephrology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ganciclovir in people with DNA Virus Infection and Herpesviridae Infections, run by Lower Saxony Center for Nephrology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00373165, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2006.