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Sponsored by: |
Medical University of Vienna |
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Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00828503 |
TITLE: A prospective, randomized safety and efficacy study of Certican® as add-on therapy against CMV-disease in renal transplant recipients
ACRONYM: Certi-CMV
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
Condition | Intervention | Phase |
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Renal Transplant |
Drug: Certican (everolimus) + valganciclovir Drug: Valganciclovir |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Certican® (Everolimus) Against Cytomegalovirus Disease in Renal Transplant Patients |
Estimated Enrollment: | 40 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 Certican + Valganciclovir: Active Comparator
Valganciclovir will be administered and Certican (everolimus) will be added as immunosuppression
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Drug: Certican (everolimus) + valganciclovir
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 judgement of the clinical investigator - a stable degree of immunosuppression is reached; thereafter Certican® trough levels will be performed at the scheduled appointments) MED 2: Valganciclovir (or ganciclovir) will be administered in addition to Certican (valganciclovir: 450 mg twice daily, ganciclovir 5 mg/kg i.v. twice daily) |
2 Valganciclovir alone: Active Comparator
Valganciclovir will be added alone.
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Drug: Valganciclovir
Valganciclovir (or ganciclovir) will be administered alone (valganciclovir: 450 mg twice daily, ganciclovir 5 mg/kg i.v. twice daily)
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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 judgement 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 judgement 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 analysed by a t-test. All other secondary endpoints and subgroup analysis will be performed in explorative intention (descriptive statistics).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 American Society of Transplantation recommendations for use in clinical trials1):
Exclusion Criteria:
Contact: Marcus D Säemann, MD | +431404005593 | marcus.saemann@meduniwien.ac.at |
Contact: Manfred Hecking, MD | +431404005593 | manfred.hecking@meduniwien.ac.at |
Austria | |
Medical University of Vienna | Recruiting |
Vienna, Austria, 1090 | |
Sub-Investigator: Manfred Hecking, MD |
Study Chair: | Sabine Schmaldienst, MD | Medical University of Vienna |
Responsible Party: | Medical University of Vienna ( Doz. Dr. Marcus Säemann ) |
Study ID Numbers: | EudraCT: 2008-004745-28 |
Study First Received: | January 23, 2009 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00828503 History of Changes |
Health Authority: | Austria: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH Spargelfeldstraße 191 1220 Vienna Austria |
immunosuppressive switch (to Certican) |
Everolimus Anti-Infective Agents Immunologic Factors Valganciclovir Ganciclovir Cytomegalovirus Immunosuppressive Agents |
Antiviral Agents Herpesviridae Infections Virus Diseases Cytomegalic Inclusion Disease Cytomegalovirus Infections DNA Virus Infections |
Everolimus Anti-Infective Agents Immunologic Factors Valganciclovir Physiological Effects of Drugs Ganciclovir Immunosuppressive Agents |
Antiviral Agents Pharmacologic Actions Herpesviridae Infections Virus Diseases Therapeutic Uses Cytomegalovirus Infections DNA Virus Infections |