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:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT02671318
Eligibility Criteria:
Inclusion Criteria:
* Adult kidney transplant recipients \> 18 y.o.
* Kidney Transplant recipients, after the first episode of cytomegalovirus infection, using the current immunosuppressive regimen: azathioprine or mycophenolate, tacrolimus and prednisone.
Exclusion Criteria:
* Re-transplant;
* Patients with any panel reactive antibody (PRA) equal to or above 50%, class I or class II;
* Acute rejection episode in the last 30 days, or episode \> 2A in the Banff criteria;
* GFR (MDRD) \< 40 ml/min;
* Proteinuria \> 0,5 g/l;
* Hemoglobin \< 10 g/l and/or leucocytes \< 4000 cels/mm3 and/or platelets \< 150.000 cels/mm3;
* Triglycerides \> 500 mg/dl with or without use of fibrate;
* Cholesterol total \> 300 mg/dl with or without use of statin;
* Hepatic abnormalities;
* Significant periphery edema;
* Pulmonary abnormalities or breast x-ray abnormalities;
* Hyper sensibility to sirolimus formula;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02671318
Study Brief:
Protocol Section:
NCT02671318