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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT03408405
Eligibility Criteria:
Inclusion Criteria:
1. Patients between the ages of 2-21 years who fail a minimum of 12 weeks of cumulative therapy with prednisone OR one other alternate immunosuppressive agent for treatment of nephrotic syndrome, will be eligible for inclusion. Nephrotic syndrome is defined as: Presence of edema, Edema, UP/C ≥2, ≥300mg/dl or 3+ protein on Albustix, and hypoalbuminemia ≤2.5 g/dL
2. Calculated GFR (eGFR) using modified Schwartz formula of \> 50 mls/min/m2. (Modified Schwartz formula = 0.413 x height (cms) ÷ serum creatinine mg/dL)
3. A clinical or biopsy diagnosis of nephrotic syndrome within the last 3 years prior to enrollment in the study.
4. Renal biopsy (if available) consistent with a diagnosis of Minimal Change Disease, IgM nephropathy, Mesangioproliferative Glomerulonephritis, Primary Focal Segmental Glomerulosclerosis or C1q Nephropathy
Exclusion Criteria:
1. Patients with an inherited or genetic disorder presenting with nephrotic syndrome (eg: NPHS 1 \& 2 defects, WT-1 mutations, α actinin 4 mutation, TRP-6 mutation).
2. Presence of diabetes or severe (stage 2) uncontrolled hypertension.
3. Any metabolic condition that specifically precludes the use of Acthar Gel for treatment.
4. Pregnancy or unwilling to agree to contraception which may include abstinence.
5. eGFR \<50 mls/min/m2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
21 Years
Study:
NCT03408405
Study Brief:
Protocol Section:
NCT03408405