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ACTHAR Gel for Drug REsistant Nephrotic Syndrome in Children

NCT03408405 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-04-23

No results posted yet for this study

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.

Conditions

  • Steroid-Resistant Nephrotic Syndrome

Interventions

DRUG

Acthar Gel 80 UNT/ML Injectable Solution

Participant will self inject 'Acthar Gel 80 UNT/ML Injectable Solution' 2 x per week for six months.

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • University of Minnesota

    collaborator OTHER

  • Medalytics

    collaborator UNKNOWN

  • Rhode Island Hospital

    lead OTHER

Principal Investigators

  • Mohammed K Faizan, MD · Rhode Island Hospital

Study Design

Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2021-01-31
Completion
2021-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03408405 on ClinicalTrials.gov