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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00441220
Eligibility Criteria:
Inclusion Criteria:
* Patients with lupus nephritis requiring therapy with intravenous cyclophosphamide
* Lupus nephritis is defined according to American College of Rheumatology criteria as the presence of either:
1. histological evidence from renal biopsy;
2. persistent proteinuria of \>0.5 g/day or proteinuria \>3+ on dipstick; or
3. cellular casts of any type. Patients will have had a renal biopsy performed to determine the histological class of lupus nephritis. Therapy with cyclophosphamide is typically used in patients with Class III, IV and severe Class V lupus nephritis.
* Patients ≥ 18 years of age
* Patients must be able to provide informed consent
Exclusion Criteria:
* Those who do not meet inclusion criteria
* Those patients in the retrospective study who have died
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00441220
Study Brief:
Protocol Section:
NCT00441220