Status:
WITHDRAWN
ACTHAR Gel for Drug REsistant Nephrotic Syndrome in Children
Lead Sponsor:
Rhode Island Hospital
Collaborating Sponsors:
Mallinckrodt
University of Minnesota
Conditions:
Steroid-Resistant Nephrotic Syndrome
Eligibility:
All Genders
2-21 years
Phase:
PHASE4
Brief Summary
We propose to study the use of purified porcine Acthar Gel (ACTHAR, Mallinckrodt Pharmaceuticals) for treatment of steroid resistance nephrotic syndrome (SRNS) in a prospective pilot study. We plan to...
Detailed Description
Treatment Protocol: Patients who fulfill inclusion criteria and who agree to participate after signing informed consent and assent forms will be treated with the following protocol: Acthar Gel will ...
Eligibility Criteria
Inclusion
- 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
- Calculated GFR (eGFR) using modified Schwartz formula of \> 50 mls/min/m2. (Modified Schwartz formula = 0.413 x height (cms) ÷ serum creatinine mg/dL)
- A clinical or biopsy diagnosis of nephrotic syndrome within the last 3 years prior to enrollment in the study.
- Renal biopsy (if available) consistent with a diagnosis of Minimal Change Disease, IgM nephropathy, Mesangioproliferative Glomerulonephritis, Primary Focal Segmental Glomerulosclerosis or C1q Nephropathy
Exclusion
- 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).
- Presence of diabetes or severe (stage 2) uncontrolled hypertension.
- Any metabolic condition that specifically precludes the use of Acthar Gel for treatment.
- Pregnancy or unwilling to agree to contraception which may include abstinence.
- eGFR \<50 mls/min/m2
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03408405
Start Date
June 1 2018
End Date
July 1 2021
Last Update
April 23 2019
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