Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT00828503
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00828503
Study Brief:
Protocol Section:
NCT00828503