Cytomegalovirus Disease Clinical Trial
Official title:
Certican® (Everolimus) Against Cytomegalovirus Disease in Renal Transplant Patients
A prospective, randomized safety and efficacy study of Certican® as add-on therapy against
CMV disease in renal transplant recipients
OBJECTIVES:
Primary Objective:
To demonstrate efficacy of Certican® as add-on therapy against CMV disease in comparison to
either valcyte® (valganciclovir) or cymevene® (ganciclovir) alone, evaluated by quantitative
measurement of CMV-DNA with PCR from the blood (qCMV-PCR)
Secondary Objectives:
To assess safety and tolerability of Certican® in patients with CMV- disease To study the
effects of Certican® treatment on quality of life
DESIGN / PHASE Prospective, single-center, randomized, parallel group, controlled, phase II
study.
PATIENTS / GROUPS 40 patients in 2 groups 20 patients per group Randomization ratio 1:1, no
stratification
INVESTIGATIONAL DRUG Oral MED 1: Certican® initial dose: 1,5-3 mg day target trough level:
3-8 ng/mL (first levels will be performed after 3 days and then adjusted until - according
to the judgment of the clinical investigator - a stable degree of immunosuppression is
reached; thereafter Certican® trough levels will be performed at the scheduled appointments)
COMPARATIVE DRUG No therapy (add-on design
CONCOMITANT MEDICATION Allowed The concomitant immunosuppressive medication will be adjusted
to the additional administration of Certican®. For example, if the patient already receives
cyclosporine A or tacrolimus, this will be adjusted, according to the current
recommendations4 at the judgment of the clinical investigator
TOLERABILITY / SAFETY ENDPOINTS:
Rejection Hematocrit Platelet count WBC count Wound healing disorders Blood lipids
(cholesterol, triglycerides) Infections (other than CMV)
PHARMACOKINETIC / PHARMACODYNAMIC ENDPOINTS Certican® (everolimus) trough levels
STATISTICAL METHODOLOGY Primary Endpoint: CMV-load (copies/mL)
Null and alternative hypotheses:
H0 Treatment with Certican® (everolimus) in combination with valcyte® (valganciclovir) or
cymevene® (ganciclovir) is equal to valcyte® (valganciclovir) or cymevene® (ganciclovir)
alone in reducing the CMV-load in renal transplant patients with CMV-disease H1: Treatment
with Certican® (everolimus) in combination with valcyte® (valganciclovir) or cymevene®
(ganciclovir) is superior to valcyte® (valganciclovir) or cymevene® (ganciclovir) in
reducing CMV load (copies/mL) in renal transplant patients with CMV-disease Type-I and -II
errors - power. α=0.05 ß=0.2 (power 0.8) Statistical methodology ANOVA of repeated measures
(CMV-copies/mL), one-sided t-test of CMV load at distinct time-points, one-sided t-test of
the time (in weeks) until CMV-load reaches ≤600 copies/mL Sample size calculation Based on a
one-sided testing and a σ of 0.2 in relative changes of CMV-copies, an α=0.05 And a ß=0.2 a
sample size of 20 patients per group was determined. Main analysis set Per-protocol
(efficacy) and intention to treat (ITT) for safety Other endpoints Bonferroni corrected
t-tests will be performed for CMV-copies/mL at each time point of the follow-up period. The
time to copies ≤ 600 will also be analyzed by a t-test. All other secondary endpoints and
subgroup analysis will be performed in explorative intention (descriptive statistics).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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