Status:
UNKNOWN
Certican® (Everolimus) Against Cytomegalovirus Disease in Renal Transplant Patients
Lead Sponsor:
Marcus Saemann
Conditions:
Cytomegalovirus Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Certi...
Detailed Description
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 stratifi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00828503
Start Date
December 1 2008
End Date
June 1 2014
Last Update
September 3 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Vienna
Vienna, Austria, Austria, 1090