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Acthar for Treatment of Post-transplant FSGS

NCT02399462 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2021-08-30

No results posted yet for this study

Summary

This is an open label safety and feasibility trial using Acthar® in addition to center-specific standard therapy including plasma exchange, for treatment of post transplant recurrent FSGS and post transplant recurrent idiopathic membranous nephropathy. Subjects will receive Acthar® 40 units subcutaneously (SC) twice weekly for two weeks then 80 units SC twice weekly for 24 weeks.

Conditions

  • FSGS
  • Renal Transplantation
  • Kidney Transplantation

Interventions

DRUG

Acthar

Agent Dose Route Schedule H.P. Acthar Gel 40 units SC twice weekly\* Weeks 1 and 2 H.P. Acthar Gel 80 units SC twice weekly\* Weeks 3 through 24 H.P. Acthar Gel 80 units SC once weekly\* Weeks 25 through 26 H.P. Acthar Gel 40 units SC once weekly\* Weeks 27 through 28 \*Injections are to be spaced 72-96 hours apart (+/-6 hours).

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Karin True, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2021-07-31
Completion
2021-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02399462 on ClinicalTrials.gov