Cytomegalovirus Disease Clinical Trial
— Certi-CMVOfficial 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
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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): - body temperature = 38°C - new or increased significant malaise - leucopenia (< 3500/mL) - atypical lymphocytosis = 5% - thrombocytopenia (platelets < 100.000/mL) - no other cause of symptoms/signs identified - informed consent of the patient Exclusion Criteria: - patients with a known hypersensitivity to everolimus, sirolimus or any of the excipients - administration of strong CYP3A4 Inhibitors (e.g. ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin) and inducers (rifampicin), unless the benefit outweighs the risk, according to the judgment of the clinical investigator - acute rejection episodes in the first 3 months after renal transplantation - active hepatitis in the previous month - Significant proteinuria (> 0.8g/24h Urine) - hepatic impairment, according to the criteria defined by Bénichou et al.2: a singular elevation of GPT or conjugated bilirubin to a value twice above the normal level, or a combined elevation of GOT, AP, and total bilirubin, given that at least one parameter is twice above the normal level - hematocrit < 25% - any significant wound healing disorder (anamnestic) - blood white blood cell (WBC) count < 3000/mL - platelets < 50.000/mL - severe dyslipidemia (cholesterol >300mg/dL, triglycerides > 350mg/dL) - uncontrolled hypertension (continuous episodes of hypertension above 140/90 (WHO classification and American Society of Transplantation recommendations 3) despite adequate hypertensive therapy) - uncontrolled hyperuricemia (uric acid > 8mg/dL) - pregnancy - any immunosuppressive protocol which does not allow the addition of Certican®, according to the judgment of the clinical investigator |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Marcus Saemann |
Austria,
Bénichou C. Criteria of drug-induced liver disorders. Report of an international consensus meeting. J Hepatol. 1990 Sep;11(2):272-6. Review. — View Citation
Humar A, Michaels M; AST ID Working Group on Infectious Disease Monitoring. American Society of Transplantation recommendations for screening, monitoring and reporting of infectious complications in immunosuppression trials in recipients of organ transplantation. Am J Transplant. 2006 Feb;6(2):262-74. — View Citation
Kasiske BL, Vazquez MA, Harmon WE, Brown RS, Danovitch GM, Gaston RS, Roth D, Scandling JD, Singer GG. Recommendations for the outpatient surveillance of renal transplant recipients. American Society of Transplantation. J Am Soc Nephrol. 2000 Oct;11 Suppl 15:S1-86. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | relative changes in CMV-load (copies/mL), as determined by qCMV-PCR from whole blood throughout the observational period | 2 years | Yes | |
Secondary | CMV-load (copies/mL) after 1-8 weeks, in months 3, 4, 6 and 12; Time (in weeks) until the CMV-load reaches =600 copies/mL | 2 years | Yes |
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