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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT00290069
Eligibility Criteria:
Inclusion Criteria:
* Both male and female patients older than 50 years who are primary recipients of a renal allograft from a donor older than 55 years.
* Patients who have given their consent previously to their participation in the study.
Exclusion Criteria:
* Recipients of a multi-organ transplant.
* Recipients of a transplant from a cadaveric donor with a cold ischemic time \> 30 hours.
* Patients with a plasma renin activity (PRA) \> 20% in 6 months previous to the inclusion.
* Breast-feeding, pregnant, or fertile women who do not use a reliable anticonceptive method before starting therapy with the study drug, during the therapy, and during the 4 months after the last dose of the drugs administered in the study.
* Patients with leukocyte count \< 2.5 x 10\^9/L, platelet count \< 100 x 10\^9/L, or haemoglobin \< 6 g/dL in the inclusion time
* Patients with active hepatic illness evidence.
* Patients with active peptic ulcer.
* Patients with serious diarrhoea or any intestinal upset that may interfere in the absorption capability of oral medication, including diabetic patients with previously diagnosticated diabetic gastroenteropathy.
* Patients with evidence of active systemic infection that require the continued use of antibiotics or evidence of HIV infection or hepatitis B presence (positive HBs-Ag) or active chronic hepatitis C.
* Patients with malignancy history (except satisfactorily treated non- melanocytic localized skin cancer and cervix "in situ" carcinoma).
* Patients with history of psychologic disease that may interfere in the patients capability to understand the study requirements.
* Patients who the investigator thinks need a treatment with any medication listed below:
* Azathioprine,
* Methotrexate,
* Cyclofosfamide,
* Polyclonal or monoclonal anti-lymphocitaries antibodies (OKT3, ATG), used for the induction in patients with high immunologic risk,
* Basiliximab, and
* Other research drugs
* Known hypersensibility or complete contraindication of any of the drugs administered in the study context or any other substance present in the study drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00290069
Study Brief:
Protocol Section:
NCT00290069