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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT00634920
Eligibility Criteria:
Inclusion Criteria:
* First or second single renal transplant from deceased or living donor
Exclusion criteria
* Recipient of organs other than a renal transplant
* Present malignancy (within the last 2 years) other than excised basal cell or squamous cell carcinoma of the skin
* Severe liver disease
* At the time of randomization 7 weeks after transplantation
In addition to the above criteria the following must be met at time of randomization:
Inclusion Criteria:
* Patients maintained on a triple immunosuppressive regime consisting of cyclosporine, Enteric coated mycophenolate, and corticosteroids
* Patients completed the first 7 weeks without experiencing any rejection
Exclusion Criteria:
* Graft loss
* Low hemoglobin value, low number of white blood cells or platelets
* High cholesterol values
* Proteinuria
* Wound healing problems
* Current severe major local or systemic infection
* Renal insufficiency
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00634920
Study Brief:
Protocol Section:
NCT00634920