Acthar for Treatment of Post-transplant FSGS

NCT ID: NCT02399462

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2021-07-31

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.

Conditions

FSGS; Renal Transplantation; Kidney Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Drug Arm

Acthar SC injections

Group Type: EXPERIMENTAL

Acthar

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

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®

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karin True, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

ACTH-101

Identifier Type: OTHER

Identifier Source: secondary_id

15-0999

Identifier Type: -

Identifier Source: org_study_id