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:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-26 @ 5:20 PM
NCT ID:
NCT01092806
Eligibility Criteria:
Inclusion Criteria:
* Renal transplant recipients on stable Tac based immunosuppressive therapy.
* 18 years of age or older.
* Stable prednisolone dose of 5 mg/day or less.
* S-creatinine below 150 umol/L.
* Signed informed consent.
Exclusion Criteria:
* Acute rejection episodes within the last 2 weeks prior to inclusion.
* Changes in Tac dosing within the last 2 weeks prior to inclusion.
* Diabetes mellitus (WHO criteria).
* Pregnant or nursing mothers or women of childbearing potential without acceptable contraception strategy.
* Concomitant treatment with: diltiazem, verapamil, fenytoin, carbamazepine, fluconazole, ketoconazole, voriconazole, erythromycin, clarithromycin.
* Patients treated with investigational drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01092806
Study Brief:
Protocol Section:
NCT01092806