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 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT00596557
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 year
* Signed informed consent
* 6 months to 15 year after heart transplantation
* Stable heart allograft function without rejection for at least 12 months
* Same immunusuppressive drugs for at least 3 months
* CNI based immunusuppression, with Cyclosporin levels C0 100-200 ng/ml FK levels of 5-10 ng/ml for preserved CNI levels.
* Poor renal function: creatinine \> 1.5 mg%.
Exclusion Criteria:
* Suspected non-compliance
* Intolerance to Everolimus
* Life expectancy \< 1year
* Proteinuria \> 1.5 g/24u/1.73m2
* Previous sirolimus treatment
* Patients who received any other investigational drug
* Patients with platelet count \<50,000/mm³ before baseline.
* Presence of severe hypercholesterolemia (≥350 mg/dL; ≥9 mmol/L) or hypertriglyceridemia (≥750 mg/dL; ≥8.5 mmol/L)
* Patients with an absolute neutrophil count of ≤ 1,500/mm3 or white blood cell count of ≤ 4000/mm³ at baseline
* Patients with a known hypersensitivity to similar drugs and to the components of the formulations
* Patients being treated with terfenadine, astemizole, or cisapride.
* Patients who are treated with drugs strong inducers or inhibitors of cytochrome P450 3A4.
* Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma)
* Patients with clinically significant systemic infection.
* Existence of any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication, and/or the presence of severe diarrhea or active peptic ulcer.
* Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00596557
Study Brief:
Protocol Section:
NCT00596557