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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004745-28-AT

Enrollment

Unknown

Registered

2008-08-11

Start date

2008-09-04

Completion date

Unknown

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: Certican® Product Name: Certican® Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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 (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • acute rejection episodes in the first 3 months after renal transplantation • active hepatitis in the month prior • hematocrit 300mg/dL, triglycerides >350mg/dL)) • uncontrolled hypertension • uncontrolled hyperuricemia • pregnancy

Design outcomes

Primary

Measure	Time frame
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. ;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).	—

Measure

Time frame

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. ;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).

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Countries

Austria

Outcome results