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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT00493194
Eligibility Criteria:
Inclusion Criteria:
1. Recipients of a renal allograft, with a minimum age of 18 years.
2. Male or female recipients. Women of child-bearing age must practice adequate contraception
3. For renal allografts from living donors, at least one HLA-mismatch is required.
4. Written informed consent, compliant with local regulations.
Exclusion Criteria:
1. Recipients of a second or third renal allograft, with a past history of graft failure due to rejection.
2. Recipients of a renal allograft from a haplotype-identical living donor or a non-heart beating donor.
3. Cold ischemia time \> 24 hours
4. Recipients of a kidney from donors ≥ 65 years of age
5. Recipients of multiple organs.
6. Pregnant women.
7. Immunological high-risk recipients, defined as current or historical PRA \> 50 %
8. Recipients with focal segmental sclerosis as primary renal disease.
9. Recipients with leucopenia (WBC \< 3000/mm³), thrombocytopenia (Thr \< 100.000/mm³),or hyperlipidemia (Tot Chol \> 300 mg/dl or Triglycerides \> 300 mg/dl)
10. Previous history of malignancy, except completely excised basocellular skin tumor
11. Chronic active infection.
12. Inadequate compliance to treatment.
13. Use of specific drugs: Terfenadine, pimozide, astemizole, fluconazole, ketoconazole and cimetidine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00493194
Study Brief:
Protocol Section:
NCT00493194