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:
NCT00659620
Eligibility Criteria:
Inclusion Criteria:
* Recipients of a renal allograft, Male and female patients age 18 to 60 years of age.
* Ability to provide written informed consent.
* The serum creatinine form 176umol/L(2mg/ml) to 440umol/L(5mg/ml)
* Renal biopsy Criteria: chronic allograft nephropathy (Banff I-II).
* Immunosuppressant:CNI and MMF and Sirolimus
* Written informed consent, compliant with local regulations.
Exclusion Criteria:
* Recipients with leucopenia (WBC \< 3000/mm³), thrombocytopenia (Thr \< 100.000/mm³),or hyperlipidemia (Tot Chol \> 300 mg/dl or Triglycerides \> 300 mg/dl).
* Recipients of multiple organs.
* Pregnant women.
* Previous history of malignancy
* Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
* Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
* Inadequate compliance to treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00659620
Study Brief:
Protocol Section:
NCT00659620