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| autoid | 4 |
| crg_id | CRG050600003 |
| titleoftrial | A randomised study comparing universal valacyclovir prophylaxis with quantitative PCR based preemptive therapy for cytomegalovirus (CMV) disease in renal transplant recipients. |
| acronymnoftrial | Preemptive therapy versus prophylaxis for CMV |
| website | http:// |
| identificationno | CMV22102003 |
| leadprefix | Dr |
| leadsurname | Reischig |
| leadgivennames | Tomas |
| leadposition | Transplant nephrologist |
| leaddepartment | Internal Medicine I |
| leadorganisation | Charles University Hospital |
| leadaddress | Alej Svobody 80, 30460 Pilsen, Czech Republic |
| leademail | reischig@fnplzen.cz |
| leadphone | +420-377103650 |
| leadfax | +420-377103506 |
| leadsuffix | |
| contactprefix | Dr |
| contactsurname | Reischig |
| contactgivennames | Tomas |
| contactposition | Transplant nephrologist |
| contactdepartment | Internal Medicine I |
| contactorganisation | Charles University Hospital |
| contactaddress | Alej svobody 80, 30460 Pilsen, Czech Republic |
| contactemail | reischig@fnplzen.cz |
| contactphone | +420-377103650 |
| contactfax | +420-377103506 |
| funding | govt |
| otherfunding | |
| fundingnameofsponsors | 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 |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | |
| actualstart | 22/10/2003 |
| proposedcompletiondate | 7/2009 |
| actualcompletiondate | |
| multi_center_study | no |
| numberofcentres | |
| multi_national_study | no |
| countrycentres | Czech Republic |
| researchquestion | 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). |
| study_status_recruitment | Recruitment completed |
| study_status_recruitment_follow | ongoing |
| healthcarecondition | Cytomegalovirus disease in renal transplant recipients |
| intervention1 | Preemptive therapy in the case of significant positivity of PCR for CMV DNA (>2000 copies/ml) - valganciclovir (Valcyte, Hoffman-La Roche, Germany) 900mg b.i.d. for a minimum of 14 days. |
| intervention2 | Universal prophylaxis (to all patients): Valacyclovir (Valtrex, Glaxo Wellcome, UK) 2g q.i.d. for 3 months.(= the control group) |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | >18 years, no upper limit |
| totalrecruitment | 60 |
| inclusion | 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 |
| exclusion | 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, WBC count <3.5 x 10exp9/L, platelet count <100 x 10exp9/L, inability to sign informed consent |
| primaryoutcomes | At 1 year: CMV disease, acute rejection (clinical + subclinical), costs directly related to CMV management, adverse events.^M At 3 years: Late CMV disease, chronic allograft nephropathy. |
| secondaryoutcomes | At 1 year: CMV infection (viremia), other infections, patient and graft survival, renal function, delayed graft function.^M At 3 years: renal function, patient and graft survival, other infections. |
| reference | 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. |