ACTHAR Gel for Drug REsistant Nephrotic Syndrome in Children
Status:
Withdrawn
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
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 enroll 25 children between the ages of 2 to 21 years.
Children fulfilling strict inclusion criteria, whose parents agree to written informed
consent after institutional IRB approval for the study, will be enrolled. Purified porcine
Acthar Gel will be administered SQ to all children using a defined treatment protocol for a
period of six months. Renal function, urine protein excretion, serum albumin levels, blood
pressure and growth parameters will be monitored closely on all patients. Baseline urine
protein excretion will be compared to end of treatment levels to determine successful
response to therapy. There will be an 18 month enrollment period, 6 month treatment period
and a 12 month follow-up period.
Phase:
Phase 4
Details
Lead Sponsor:
Rhode Island Hospital
Collaborators:
Mallinckrodt Medalytics University of Minnesota University of Minnesota, MN