Acthar for Treatment of Post-transplant FSGS

Acthar for Treatment of Post-transplant FSGS

Sponsors

Lead Sponsor: University of North Carolina, Chapel Hill

Collaborator: Mallinckrodt

Source University of North Carolina, Chapel Hill
Brief 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.

Overall Status Not yet recruiting
Start Date November 2020
Completion Date June 2023
Primary Completion Date June 2022
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
number of patients with proteinuria 24 and 52 weeks
Secondary Outcome
Measure Time Frame
Graft loss during study period
eGFR change weeks 4,8,12,16,20 and 24
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: Acthar

Description: 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).

Arm Group Label: Study Drug Arm

Other Name: ACTH (adrenocorticotropic hormone ), corticotropin

Eligibility

Criteria:

Inclusion Criteria: - Age > 18 years - Proteinuria > 1 g/d by urine protein/creatinine ratio (UP/C) or 24 hour urine collection - If treated with an angiotensin-converting-enzyme inhibitor (ACEi) or Angiotensin II receptor blockers (ARB), must be on a stable dose for at least 2 weeks prior to enrollment - Newly diagnosed recurrent focal and segmental glomerulosclerosis (FSGS), or current/previous treatment of recurrent FSGS with no evidence of at least a partial response as defined by one or more of the following: 1. Recurrent FSGS confirmed by renal transplant biopsy (FSGS on light microscopy and/or foot process effacement on electron microscopy), with FSGS as the primary disease confirmed by native renal biopsy prior to transplant 2. FSGS confirmed by renal transplant biopsy (FSGS on light microscopy and/or foot process effacement on electron microscopy), within 18 months post transplant 3. Patients at any time period post transplant with an established diagnosis of recurrent FSGS in the first 18 months post transplant who did not respond to conventional therapy as defined by persistent proteinuria of > 3 g/d by UP/C or 24 hour urine collection Exclusion Criteria: - Lactation, pregnancy or refusal of birth control in women of childbearing potential - Infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or parvovirus B-19 - Malignancy (with the exception of treated and cured basal cell or squamous cell carcinoma) - Evidence of diabetic nephropathy, transplant glomerulopathy or other pathologies that could be associated with secondary FSGS on renal transplant biopsy - Non-renal organ transplant (with the exception of pancreas transplant) - Contraindication to receiving Acthar®

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Karin True, MD Principal Investigator University of North Carolina, Chapel Hill
Overall Contact

Last Name: Karin True, MD

Phone: 919-445-2687

Email: [email protected]

Location
Facility: University of North Carolina at Chapel Hill
Location Countries

United States

Verification Date

September 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Study Drug Arm

Type: Experimental

Description: Acthar SC injections

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov