Certican (Everolimus®) against Cytomegalovirus Disease in Renal Transplant Patients

Phase 1

Registration Number: EUCTR2008-004745-28-AT

Lead Sponsor: Medizinische Universität Wien, KIM III, Abteilung für Nephrologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•CMV-disease after renal transplantation, i.e.(1.) CMV present in the blood, and (2.) one of the following symptoms (for viral syndrome, from the Amercan Society of Transplantation recommendations for use in clinical trials): body temperature =38°C, new or increased significant malaise, leucopenia (<3500/mL), atypical lymphocytosis =5%, thrombocytopaenia (platelets <100.000/mL)
•informed consent of the patient

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•acute rejection episodes in the first 3 months after renal transplantation
•active hepatitis in the month prior
•hematocrit <25%
•any significant wound healing disorder
•blood white blood cell (WBC) count <3000/mL
•platelets <50.000/mL
•severe dyslipidemia (cholesterol >300mg/dL, triglycerides >350mg/dL))
•uncontrolled hypertension
•uncontrolled hyperuricemia
•pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to demonstrate treatment efficacy of Certican® (everolimus) as add-on therapy against CMV-disease in comparison to either valganciclovir or ganciclovir alone, as measured by qCMV-PCR titers.;Secondary Objective: The secondary objectives are to demonstrate the efficacy of Certican® as add-on therapy against CMV-disease in comparison to either valganciclovir or ganciclovir alone and to assess the safety and the tolerability of Certican® in patients with CMV-disease. Moreover, to study the effects of Certican® treatment on the quality of life.<br><br>;Primary end point(s): The primary endpoint is the lowering of CMV-titers, as determined by qCMV PCR, statistically analyzed by comparing the CMV-titer curves of the Certican® group versus the other (by ANOVA).

Secondary Outcome Measures