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 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT00154232
Eligibility Criteria:
Inclusion Criteria:
\- Age 18-70 years old
* Patients receiving a primary or secondary cadaveric or living donor kidney
* Patients who have given written informed consent for study participation
* Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice birth control for the duration of the study and at least for four months following the last dose of basiliximab.
Exclusion Criteria:
* Recipient of multi-organ transplants or previously transplanted organs other than kidney
* Recipient of dual kidney transplants
* Recipient of a transplanted kidney from a Non-Heart Beating Donor (NHBD)
* Recipient of a HLA identical living-donor kidney
* Patients with a PRA level (past or current level) greater than 20%
* Patients anticipated by investigators to require induction therapy with OKT3, ATGAM, or Thymoglobulin for any reason
* Patients with any medical condition which, in the opinion of the investigator, would preclude the patient from participating in the study
* Cold ischemia time larger than 36 hours.
* Patients who have received an investigational drug or therapy within one month prior to study entry or if such therapy is to be instituted post-transplantation.
* Female transplant candidates who are pregnant, lactating, or of childbearing potential and not willing to practice an acceptable method of contraception
* Patients with a known hypersensitivity to cyclosporine
* Patients with a known malignancy or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin
* Known HIV positive antibody status
* Evidence of any clinically relevant (per investigator determination) active infection
* Patients unable to participate in the study for the full 3-month study period
* Other protocol-defined exclusion criteria may apply.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00154232
Study Brief:
Protocol Section:
NCT00154232