Cytomegalovirus InfectionsPhase 3NCT00372229

A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation

A Phase 3 study testing Valganciclovir CMV Prophylaxis, Valganciclovir (Pre-emptive CMV Therapy) and Ganciclovir in people with Cytomegalovirus Infections, run by Hoffmann-La Roche at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cytomegalovirus Infections
What is being tested?: Valganciclovir CMV Prophylaxis, Valganciclovir (Pre-emptive CMV Therapy) and Ganciclovir
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 299 participants
Where: 24 sitesin 2 countries
Study dates: May 2006to Oct 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

primary or secondary renal allograft within preceding 14 days;
IgG seropositive for CMV;
receiving immunosuppressive therapy.

Who cannot join

active CMV infection;
current/history of malignancy;
acute steroid resistant rejection episode since transplantation.

Trial locations and contacts

24 sites in 2 countries.

Country

City, postcode or hospital

24 sites in 2 countries

Germany22 sites

Study site
Aachen, 52057
Study site
Berlin, 12203
Study site
Berlin, 13353
Study site
Bremen, 28205
Study site
Cologne, 50937
Study site
Düsseldorf, 40225
Study site
Erlangen, 91054
Study site
Essen, 45122
Study site
Frankfurt, 60596
Study site
Freiburg im Breisgau, 79106
Study site
Hamburg, 20246
Study site
Hannoversch Münden, 34346
Study site
Hanover, 30625
Study site
Jena, 07747
Study site
Leipzig, 04103
Study site
Lübeck, 23562
Study site
München, 81377
Study site
München, 81675
Study site
Münster, 48149
Study site
Regensburg, 93053
Study site
Tübingen, 72076
Study site
Würzburg, 97080

Other trials in Germany

Austria2 sites

Study site
Innsbruck, 6020
Study site
Vienna, 1090

Other trials in Austria

About this study

Official title: A Randomized Trial Comparing Valcyte CMV Prophylaxis Versus Pre-emptive Therapy After Renal Transplantation Using Proteomics for Monitoring of Graft Alteration

This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po daily) prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active CMV infection, in CMV positive renal transplant recipients. The influence of the two prevention concepts on the occurrence of direct and indirect effects of active CMV infections will be compared. The anticipated time on study treatment is 3 months-1 year, and the target sample size is 100-500 individuals.

Conditions: Cytomegalovirus Infections
Being tested: Valganciclovir CMV Prophylaxis, Valganciclovir (Pre-emptive CMV Therapy), Ganciclovir
Medical subject headings: Cytomegalovirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Valganciclovir CMV ProphylaxisDrug
Also called Valcyte
900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
Valganciclovir (Pre-emptive CMV Therapy)Drug
Also called Valcyte
If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function. If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
GanciclovirDrug
If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.

Study groups in NCT00372229
Study group	Role	What they receive
Valganciclovir Cytomegalovirus (CMV) Prophylaxis	Experimental	Not described Receives: Drug: Valganciclovir CMV Prophylaxis
Pre-emptive CMV Therapy	Active comparator	Not described Receives: Drug: Valganciclovir (Pre-emptive CMV Therapy); Drug: Ganciclovir

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Measured: Up to 12 months
Percentage of Participants With CMV Disease Within 12 Months Including CMV Syndrome and Tissue Invasive Disease
CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Measured: Up to 12 months
Urine Proteomic Pattern at Month 12
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. Urine proteomic pattern was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Measured: Up to 12 months
Percentage of Participants With Graft Loss at Month 84
Measured: Up to 84 months

Secondary outcomes (38)

Percentage of Participants With CMV Syndrome Within 12 Months
CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN).
Measured: Up to 12 months
Percentage of Participants With CMV Tissue Invasive Disease Within 12 Months
CMV tissue invasive disease was defined as viremia: PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Measured: Up to 12 months
Time to Occurrence of First Viremia Within 12 Months
Viremia was defined as plasma PCR ≥ 400 copies/ml.
Measured: Up to 12 months
Viral Burden at Viremia
Time-weighted area under the curve (AUC) of the polymerase chain reaction (PCR). Viremia was defined as plasma PCR ≥ 400 copies/ml.
Measured: Up to 12 months
Creatinine Clearance at Month 12
Creatinine clearance was estimated using the Cockcroft-Gault formula.
Measured: Up to 12 months
Percentage of Participants With at Least One Treated and Biopsy-Proven Acute Rejection Episode Within 12 Months
Measured: Up to 12 months
Days of Hospitalization
Measured: Up to 12 months
Relationship Between Proteomics Pattern and Graft Survival
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CKD273, CMV, and nephropathy was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Measured: Up to 12 months
Relationship Between Proteomics Pattern and Participant Survival
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CKD273, CMV, and nephropathy was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Measured: Up to 12 months
Proteomics Parameter: CKD273
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CKD273 was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Measured: Up to 12 months
Proteomics Parameter: CMV
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CMV was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Measured: Up to 12 months
Proteomics Parameter: Nephropathy
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of nephropathy was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Measured: Up to 12 months
Percentage of Participants Surviving at Month 12
Measured: Up to 12 months
Percentage of Participants With Graft Survival at Month 12
Measured: Up to 12 months
Percentage of Participants With Leukopenia Within 12 Months
Leukopenia: white blood cell (WBC) of < 3,500/microlitre (μL) and < 1,000/μL
Measured: Up to 12 months
Percentage of Participants With Neutropenia Within 12 Months
Neutropenia: absolute neutrophil count (ANC) < 750/μL within 12 months.
Measured: Up to 12 months
Percentage of Participants With Any Opportunistic Infection Within 12 Months
Measured: Up to 12 months
Percentage of Participants With Post-Transplant Diabetes Mellitus
Measured: Up to 12 months
Percentage of Participants With Active CMV Infections Not Responding to Valganciclovir or IV Ganciclovir Treatment
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Measured: Up to 12 months
Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84
Viremia (active CMV Infection) was defined as PCR ≥ 400 copies/ml.
Measured: From Month 24 to Month 84
Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84
CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Measured: From Month 24 to Month 84
Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84
CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN).
Measured: From Month 24 to Month 84
Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84
CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Measured: From Month 24 to Month 84
Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Measured: From Month 24 to Month 84
Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84
CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Measured: From Month 24 to Month 84
Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84
Measured: From Month 24 to Month 84
Number of Participants Who Died From Months 24 to Month 84
Measured: From Month 24 to Month 84
Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84
Measured: From Month 24 to Month 84
Number of Participants Who Had Lost Their Transplant up to Month 84
Measured: From Month 24 to Month 84
Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84
Measured: From Month 24 to Month 84
Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84
Measured: From Month 24 to Month 84
Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Valganciclovir CMV Prophylaxis With First Occurrence of Graft Loss at Month 84
An analysis for the time to first occurrence of graft loss within month 84 (by means of Kaplan-Meier analysis) was done for all patients who suffered at least once from acute CMV infection (CMV viremia) during this study versus all patients who did not suffer from acute CMV infection (CMV viremia) during the study. Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Measured: Up to 84 months
Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Pre-emptive CMV Therapy With First Occurrence of Graft Loss at Month 84
An analysis for the time to first occurrence of graft loss within month 84 (by means of Kaplan-Meier analysis) was done for all patients who suffered at least once from acute CMV infection (CMV viremia) during this study versus all patients who did not suffer from acute CMV infection (CMV viremia) during the study. Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Measured: Up to 84 months
Number of Participants Who Had Lost Their Transplant or Died up to Month 84
Measured: From Month 24 to Month 84
Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84
Measured: From Month 24 to Month 84
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
Measured: From Month 24 to Month 84
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
Measured: From Month 24 to Month 84
Creatinine Clearance at Month 24 and Every 12 Months up to Month 84
Creatinine Clearance estimated by Cockcroft-Gault formula.
Measured: From Month 24 to Month 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2006Oct 2015

First posted6 Sep 2006 (estimated)
Study startMay 2006
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 299 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00372229
Sponsor's protocol ID: ML19313
Status last verified: Feb 2020
First submitted: 5 Sep 2006
Last updated: 11 Mar 2020
Results posted: Yes, on ClinicalTrials.gov

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 39807668
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.
PubMed 38700045
Mazzola P, Schaeffeler E, Witzke O, Nitschke M, Kliem V, Zortel M, Wagner EM, Schwab M, Hauser IA. No association of genetic variants in TLR4, TNF-alpha, IL10, IFN-gamma, and IL37 in cytomegalovirus-positive renal allograft recipients with active CMV infection-Subanalysis of the prospective randomised VIPP study. PLoS One. 2021 Apr 16;16(4):e0246118. doi: 10.1371/journal.pone.0246118. eCollection 2021.
PubMed 33861738
Witzke O, Nitschke M, Bartels M, Wolters H, Wolf G, Reinke P, Hauser IA, Alshuth U, Kliem V. Valganciclovir Prophylaxis Versus Preemptive Therapy in Cytomegalovirus-Positive Renal Allograft Recipients: Long-term Results After 7 Years of a Randomized Clinical Trial. Transplantation. 2018 May;102(5):876-882. doi: 10.1097/TP.0000000000002024.
PubMed 29166336

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 2
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All Cytomegalovirus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial Comparing Valcyte CMV Prophylaxis Versus Pre-emptive Therapy After Renal Transplantation Using Proteomics for Monitoring of Graft Alteration
ClinicalTrials.gov ID: NCT00372229
Acronym / sponsor ID: ML19313
Conditions: Cytomegalovirus Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 299 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 6 Sep 2006 (estimated)
Results: Posted 11 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Valganciclovir Cytomegalovirus (CMV) Prophylaxis	Experimental	Drug: Valganciclovir CMV Prophylaxis
Pre-emptive CMV Therapy	Active comparator	Drug: Valganciclovir (Pre-emptive CMV Therapy), Drug: Ganciclovir

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

primary or secondary renal allograft within preceding 14 days;
IgG seropositive for CMV;
receiving immunosuppressive therapy.

Key exclusion criteria (3 listed)

active CMV infection;
current/history of malignancy;
acute steroid resistant rejection episode since transplantation.

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
Valganciclovir CMV ProphylaxisAlso: Valcyte900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.	Drug	Valganciclovir Cytomegalovirus (CMV) Prophylaxis
Valganciclovir (Pre-emptive CMV Therapy)Also: ValcyteIf plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function. If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.	Drug	Pre-emptive CMV Therapy
GanciclovirIf CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.	Drug	Pre-emptive CMV Therapy

Primary outcome

Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months
Time frame: Up to 12 months
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Percentage of Participants With CMV Disease Within 12 Months Including CMV Syndrome and Tissue Invasive Disease
Time frame: Up to 12 months
CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Urine Proteomic Pattern at Month 12
Time frame: Up to 12 months
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. Urine proteomic pattern was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Percentage of Participants With Graft Loss at Month 84
Time frame: Up to 84 months

38 secondary outcomes

Percentage of Participants With CMV Syndrome Within 12 Months
Time frame: Up to 12 months
Percentage of Participants With CMV Tissue Invasive Disease Within 12 Months
Time frame: Up to 12 months
Time to Occurrence of First Viremia Within 12 Months
Time frame: Up to 12 months
Viral Burden at Viremia
Time frame: Up to 12 months
Creatinine Clearance at Month 12
Time frame: Up to 12 months
Percentage of Participants With at Least One Treated and Biopsy-Proven Acute Rejection Episode Within 12 Months
Time frame: Up to 12 months
Days of Hospitalization
Time frame: Up to 12 months
Relationship Between Proteomics Pattern and Graft Survival
Time frame: Up to 12 months
Relationship Between Proteomics Pattern and Participant Survival
Time frame: Up to 12 months
Proteomics Parameter: CKD273
Time frame: Up to 12 months
Proteomics Parameter: CMV
Time frame: Up to 12 months
Proteomics Parameter: Nephropathy
Time frame: Up to 12 months
Percentage of Participants Surviving at Month 12
Time frame: Up to 12 months
Percentage of Participants With Graft Survival at Month 12
Time frame: Up to 12 months
Percentage of Participants With Leukopenia Within 12 Months
Time frame: Up to 12 months
Percentage of Participants With Neutropenia Within 12 Months
Time frame: Up to 12 months
Percentage of Participants With Any Opportunistic Infection Within 12 Months
Time frame: Up to 12 months
Percentage of Participants With Post-Transplant Diabetes Mellitus
Time frame: Up to 12 months
Percentage of Participants With Active CMV Infections Not Responding to Valganciclovir or IV Ganciclovir Treatment
Time frame: Up to 12 months
Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84
Time frame: From Month 24 to Month 84
Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84
Time frame: From Month 24 to Month 84
Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84
Time frame: From Month 24 to Month 84
Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84
Time frame: From Month 24 to Month 84
Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84
Time frame: From Month 24 to Month 84
Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84
Time frame: From Month 24 to Month 84
Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84
Time frame: From Month 24 to Month 84
Number of Participants Who Died From Months 24 to Month 84
Time frame: From Month 24 to Month 84
Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84
Time frame: From Month 24 to Month 84
Number of Participants Who Had Lost Their Transplant up to Month 84
Time frame: From Month 24 to Month 84
Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84
Time frame: From Month 24 to Month 84
Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84
Time frame: From Month 24 to Month 84
Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Valganciclovir CMV Prophylaxis With First Occurrence of Graft Loss at Month 84
Time frame: Up to 84 months
Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Pre-emptive CMV Therapy With First Occurrence of Graft Loss at Month 84
Time frame: Up to 84 months
Number of Participants Who Had Lost Their Transplant or Died up to Month 84
Time frame: From Month 24 to Month 84
Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84
Time frame: From Month 24 to Month 84
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
Time frame: From Month 24 to Month 84
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
Time frame: From Month 24 to Month 84
Creatinine Clearance at Month 24 and Every 12 Months up to Month 84
Time frame: From Month 24 to Month 84

Results and safety

Results posted to the registry on 11 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Valganciclovir Cytomegalovirus (CMV) Prophylaxis	148	117
Pre-emptive CMV Therapy	151	122

Primary outcome: Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months

Time frame: Up to 12 months. Number (96% Confidence Interval). Unit: percentage of participants

Measure	Valganciclovir CMV Prophylaxis n = 148	Pre-emptive CMV Therapy n = 151
Value	14.1 (7.0 to 21.1)	42.6 (33.9 to 51.3)

Valganciclovir CMV Prophylaxis vs Pre-emptive CMV Therapy: Difference: -28.5 (96% CI -39.7 to -17.3)

Population analysed: The intent-to-treat (ITT) population included all randomized participants.

Primary outcome: Percentage of Participants With CMV Disease Within 12 Months Including CMV Syndrome and Tissue Invasive Disease

Time frame: Up to 12 months. Number (96% Confidence Interval). Unit: percentage of participants

Measure	Valganciclovir CMV Prophylaxis n = 148	Pre-emptive CMV Therapy n = 151
Value	5.6 (1.4 to 9.8)	16.9 (10.3 to 23.6)

Valganciclovir CMV Prophylaxis vs Pre-emptive CMV Therapy: Difference: -11.3 (96% CI -19.2 to -3.4)

Population analysed: The intent-to-treat (ITT) population included all randomized participants.

Primary outcome: Urine Proteomic Pattern at Month 12

Time frame: Up to 12 months. Least squares mean (Standard Error). Unit: units on a scale

Measure	Valganciclovir CMV Prophylaxis n = 148	Pre-emptive CMV Therapy n = 151
Value	-0.1057 (0.1538)	0.1452 (0.1006)

Valganciclovir CMV Prophylaxis vs Pre-emptive CMV Therapy: Mean Difference (Final Values): 0.2509 (99% CI -0.2271 to 0.7289), p = 0.1739, F-test

Population analysed: The intent-to-treat (ITT) population included all randomized participants.

Primary outcome: Percentage of Participants With Graft Loss at Month 84

Time frame: Up to 84 months. Number. Unit: percentage of participants

Measure	Valganciclovir CMV Prophylaxis n = 148	Pre-emptive CMV Therapy n = 151
Value	7.43	8.61

Population analysed: The intent-to-treat (ITT) population included all randomized participants. Descriptive analysis only.

38 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 7 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Valganciclovir CMV Prophylaxis	94 of 148 (63.5%)	139 of 148 (93.9%)	Not reported
Pre-emptive CMV Therapy	96 of 151 (63.6%)	140 of 151 (92.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Derived from this study: PubMed 33861738Mazzola P, Schaeffeler E, Witzke O, Nitschke M, Kliem V, Zortel M, Wagner EM, Schwab M, Hauser IA. No association of genetic variants in TLR4, TNF-alpha, IL10, IFN-gamma, and IL37 in cytomegalovirus-positive renal allograft recipients with active CMV infection-Subanalysis of the prospective randomised VIPP study. PLoS One. 2021 Apr 16;16(4):e0246118. doi: 10.1371/journal.pone.0246118. eCollection 2021.
Derived from this study: PubMed 29166336Witzke O, Nitschke M, Bartels M, Wolters H, Wolf G, Reinke P, Hauser IA, Alshuth U, Kliem V. Valganciclovir Prophylaxis Versus Preemptive Therapy in Cytomegalovirus-Positive Renal Allograft Recipients: Long-term Results After 7 Years of a Randomized Clinical Trial. Transplantation. 2018 May;102(5):876-882. doi: 10.1097/TP.0000000000002024.

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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.

Clinical Trials study director

Hoffmann-La Roche

24 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 3 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 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months (time frame: Up to 12 months). The study lists 4 primary outcomes in all. 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 NCT00372229, which also lists 4 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 11 Mar 2020.