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 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT00782561
Eligibility Criteria:
Inclusion Criteria:
1. Age 12-64 years, inclusive, and girls age 10-11 years, inclusive if Tanner stage 3 or greater
2. Biopsy diagnosis of primary FSGS with biopsy confirmed centrally
3. Age less than or equal to 2 years old at onset of proteinuria
4. First morning urine protein/creatinine ratio (U p/c) \>1 gm/gm
5. Estimated glomerular filtration rate greater than or equal to 40 mL/min/1.73 m2
Exclusion Criteria:
1. Non-FSGS renal disease other than benign cyst; or secondary FSGS
2. History of organ transplantation
3. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
4. History of malignancy, cardiovascular disease, diabetes mellitus, sickle cell disease, multiple sclerosis, systemic lupus erythematosus, or active or recurrent serious infections (including but not limited to Hepatitis B, Hepatitis C, or HIV)
5. Participation in studies of investigational drugs within 6 weeks prior to Day 0 or receipt of an investigational drug within 12 weeks prior to Day 0
6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 times the upper limit of normal
7. Hematocrit \< 30%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
64 Years
Study:
NCT00782561
Study Brief:
Protocol Section:
NCT00782561