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Trial registered on ANZCTR


Registration number
ACTRN12610000015044
Ethics application status
Approved
Date submitted
22/12/2009
Date registered
21/06/2005
Date last updated
4/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preemptive therapy vs valacyclovir prophylaxis for cytomegalovirus (CMV) disease after renal transplantation
Scientific title
A randomised study comparing universal valacyclovir prophylaxis with quantitative polymerase chain reaction (PCR) based preemptive therapy for cytomegalovirus (CMV) disease in renal transplant recipients.
Secondary ID [1] 973 0
CRG050600003
Cochrane Renal Group
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cytomegalovirus disease in renal transplant recipients 243634 0
Condition category
Condition code
Infection 256606 256606 0 0
Studies of infection and infectious agents
Renal and Urogenital 256643 256643 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Preemptive therapy in the case of significant positivity of PCR for CMV deoxyribonucleic acid (DNA) (>2000 copies/ml) - oral valganciclovir (Valcyte, Hoffman-La Roche, Germany) 900mg twice per day until clearance of CMV viremia (negative result of PCR for CMV DNA) or for a minimum of 14 days commenced during first year post-transplant.
Intervention code [1] 255732 0
Prevention
Intervention code [2] 255773 0
Treatment: Drugs
Comparator / control treatment
Universal prophylaxis (to all patients in comparator group): oral valacyclovir (Valtrex, Glaxo Wellcome, UK) 2g four times per day for 3 months started within 1 week post-transplant (= the control group)
Control group
Active

Outcomes
Primary outcome [1] 240712 0
Cumulative incidence of CMV disease (defined by clinical symptoms + presence of CMV viremia by quantitative PCR CMV DNA test)
Timepoint [1] 240712 0
12 months post transplant
Primary outcome [2] 257498 0
acute rejection (clinical + subclinical) diagnosed by renal allograft biopsy
Timepoint [2] 257498 0
12 months post transplant
Primary outcome [3] 257499 0
Histologically proven interstitial fibrosis/tubular atrophy of the allograft, expression of messenger ribonucleic acid (mRNA) cytokines intragraft included
Timepoint [3] 257499 0
36 months post transplant
Secondary outcome [1] 257368 0
Cumulative incidence of CMV infection (viremia), intragraft CMV included (defined by positive PCR for CMV DNA in blood or renal allograft biopsy specimen)
Timepoint [1] 257368 0
12 months post transplant
Secondary outcome [2] 262701 0
other infections assessed by clinical symptoms, microbiological cultures, blood tests
Timepoint [2] 262701 0
12 months post transplant
Secondary outcome [3] 262702 0
Cumulative patient and graft survival based on prospective observation
Timepoint [3] 262702 0
12 moths post transplant
Secondary outcome [4] 262703 0
adverse events based on prospective observation (examples od side effects - heamatological - leukopenia, trombocytopenia, anemia, psychiatric - hallucinations+confusion, liver enzyme abnormalities, de novo post transplant diabetes, de novo malignancy, etc.)
Timepoint [4] 262703 0
12 months post transplant
Secondary outcome [5] 262704 0
renal function assessed by serum creatinine and estimated glomerular filtration rate
Timepoint [5] 262704 0
12 months post transplant
Secondary outcome [6] 262705 0
delayed graft function (defined by the need of dialysis within first week post transplant)
Timepoint [6] 262705 0
1 week post transplant
Secondary outcome [7] 262706 0
renal function assessed by serum creatinine and estimated glomerular filtration rate
Timepoint [7] 262706 0
36 months post transplant
Secondary outcome [8] 262707 0
Cumulative patient and graft survival based on prospective observation
Timepoint [8] 262707 0
36 months post transplant
Secondary outcome [9] 262708 0
chronic rejection (humoral/cellular) diagnosed by renal allograft biopsy
Timepoint [9] 262708 0
36 months post transplant
Secondary outcome [10] 262709 0
other infections assessed by clinical symptoms, microbiological cultures, blood tests
Timepoint [10] 262709 0
36 months post transplant
Secondary outcome [11] 262772 0
Late onset CMV disease (defined by clinical symptoms + presence of CMV viremia by quantitative PCR CMV DNA test)
Timepoint [11] 262772 0
36 months post transplant

Eligibility
Key inclusion criteria
adult (>18 years) renal transplant recipient, donor (D) and recipient (R) pretransplant CMV serological status: D+/R-, D+/R+, D-/R+, deceased (including non-heart-beating) or living donor, informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unknown or D-/R- CMV serostatus pretransplant, allergy to acyclovir, valacyclovir, ganciclovir, and/or valganciclovir, active viral infection at the time of transplantation (including active hepatitis B infection), therapy with systemic antiviral agents <2 weeks prior to transplantation, white blood cell (WBC) count <3.5 x 10exp9/L, platelet count <100 x 10exp9/L, inability to sign informed consent, concomitant inclusion to another clinical trial

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All subjects indicated to kidney transplantation were considered for inclusion to the trial prior to transplantation. If the patient met inclusion criteria and signed informed consent randomization occurred. Hidden numbered envelops containing the treatment arm were used. Thus the treatment arm was consealed to the researcher until the patient had been included to the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random-number table, 1:1 ratio
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/10/2003
Actual
22/10/2003
Date of last participant enrolment
Anticipated
1/05/2006
Actual
11/08/2006
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 1985 0
Czech Republic
State/province [1] 1985 0

Funding & Sponsors
Funding source category [1] 243581 0
Government body
Name [1] 243581 0
Supported by Research Project No. MSM0021620819 'Replacement of and Support to Some Vital Organs' awarded by the Ministry of Education, Youth, and Physical Training of the Czech Republic
Country [1] 243581 0
Czech Republic
Primary sponsor type
Individual
Name
Tomas Reischig, M.D., Ph.D.
Address
Head of Division of Nephrology,
Department of Internal Medicine I
Charles University Medical School and Teaching Hospital,
alej Svobody 80,
30460 Pilsen
Czech Republic
Country
Czech Republic
Secondary sponsor category [1] 251548 0
None
Name [1] 251548 0
Address [1] 251548 0
Country [1] 251548 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258309 0
Local Ethics Committee of Charles University Medical School and Teaching Hospital in Pilsen
Ethics committee address [1] 258309 0
Local Ethics Committee (director: Prof. J. Finek, M.D., Ph.D.), Charles University Medical School and Teaching Hospital, alej Svobody 80, 304 60 Pilsen, Czech Republic
Ethics committee country [1] 258309 0
Czech Republic
Date submitted for ethics approval [1] 258309 0
23/06/2003
Approval date [1] 258309 0
20/07/2003
Ethics approval number [1] 258309 0

Summary
Brief summary
The aim of the study is to compare the efficacy, safety and cost of preemptive therapy with vaganciclovir (based on quantitative PCR monitoring) versus universal 3-month prophylaxis with valacyclovir (control group, current standard in our transplant centre).
Trial website
not available
Trial related presentations / publications
Reischig T, Jindra P, Hes O, Svecova M, Klaboch J, Treska V. Valacyclovir prophylaxis versus preemptive valganciclovir therapy to prevent cytomegalovirus disease after renal transplantation. American Journal of Transplantation 2008 Jan;8(1):69-77.

Reischig T, Hribova P, Jindra P, Hes O, Bouda M, Treska V, Viklicky O. Pre-emptive valganciclovir therapy compared with valacyclovir prophylaxis for prevention of cytomegalovirus: 4-year results of a randomized trial in renal transplant recipients. J Am Soc Nephrol 2012, 23(9): 1588-97.
Public notes

Contacts
Principal investigator
Name 30122 0
A/Prof Tomas Reischig
Address 30122 0
Transplant nephrologist, Internal Medicine I, Charles University Hospital, Alej Svobody 80, 30460 Pilsen, Czech Republic
Country 30122 0
Czech Republic
Phone 30122 0
+420377103650
Fax 30122 0
Email 30122 0
[email protected]
Contact person for public queries
Name 13369 0
Tomas Reischig, M.D., Ph.D.
Address 13369 0
Transplant nephrologist, Internal Medicine I, Charles University Hospital, Alej Svobody 80, 30460 Pilsen, Czech Republic
Country 13369 0
Czech Republic
Phone 13369 0
+420 377103650
Fax 13369 0
Email 13369 0
[email protected]
Contact person for scientific queries
Name 4297 0
Tomas Reischig, M.D., Ph.D.
Address 4297 0
Transplant nephrologist, Internal Medicine I, Charles University Hospital, Alej svobody 80, 30460 Pilsen, Czech Republic
Country 4297 0
Czech Republic
Phone 4297 0
+420 377103650
Fax 4297 0
Email 4297 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe impact of viral load and time to onset of cytomegalovirus replication on long-term graft survival after kidney transplantation.2017https://dx.doi.org/10.3851/IMP3129
EmbaseCytomegalovirus prevention strategies and the risk of BK polyomavirus viremia and nephropathy.2019https://dx.doi.org/10.1111/ajt.15507
N.B. These documents automatically identified may not have been verified by the study sponsor.