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

• Status: Unknown status
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marcus Saemann
• Treatments: Everolimus; Ganciclovir; Sirolimus; Valganciclovir

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 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