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 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT02132195
Eligibility Criteria:
Inclusion Criteria:
1. Age \>1 year at onset of nephrotic syndrome
2. Age 2-20 years at time of randomization
3. Estimated glomerular filtration rate (GFR) \> 50 ml/min/1.73 m2 at most recent measure prior to randomization (Schwartz formula)
4. Steroid responsive nephrotic syndrome throughout clinical course (never required a second agent to attain remission of a relapse of nephrotic syndrome)
5. History of frequently relapsing or steroid dependent nephrotic syndrome (defined as 2 or more relapses within 6 months after initial therapy or 4 or more relapses in any 12 month period OR relapse during taper or within 2 weeks of discontinuing prednisone).
6. Patient is currently in relapse of nephrotic syndrome or had a relapse within the last 4 months (defined as an increase in the first morning urine protein to creatinine ratio ≥2 or Albustix reading of ≥2 for 3 or 5 consecutive days).
Exclusion Criteria:
1. Prior treatment with ACTH.
2. Cyclophosphamide or rituximab within the last 4 months.
3. Lactation, pregnancy, or refusal of birth control in females with child-bearing potential
4. Planned treatment with live or live-attenuated vaccines once enrolled in the study.
5. Participation in another therapeutic trial concurrently or 30 days prior to randomization
6. Active/serious infection (including, but not limited to Hepatitis B or C, HIV)
7. Malignancy concurrently or within the last 2 years.
8. Blood pressure \>95% for age/height while receiving maximal doses of 3 or more medications.
9. Prior diagnosis of diabetes mellitus (Type I or II) or fasting glucose \>200mg/dL
10. Organ transplantation
11. Contraindications to Acthar: scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, or adrenal cortical hyperfunction
12. Secondary cause of nephrotic syndrome (e.g., SLE)
13. Biopsy demonstrating a diagnosis other than minimal change, focal segmental glomerulosclerosis (FSGS) or a variant (mesangial proliferation, Immunoglobulin M nephropathy)
14. Inability to consent/assent -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
20 Years
Study:
NCT02132195
Study Brief:
Protocol Section:
NCT02132195