Acthar for Treatment of Post-transplant FSGS

NCT02399462 | Withdrawn Phase 4 FDA Drug

• 2 other identifiers: 15-0999ACTH-101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• number of patients with proteinuria

  partial and complete remission of proteinuria

  24 and 52 weeks

Secondary Outcomes (2)

• Graft loss

  during study period

• eGFR change

  weeks 4,8,12,16,20 and 24

Study Arms (1)

Study Drug Arm

EXPERIMENTAL

Acthar SC injections

Drug: Acthar

Interventions

Acthar 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).

Also known as: ACTH (adrenocorticotropic hormone ), corticotropin

Study Drug Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• FSGS confirmed by renal transplant biopsy (FSGS on light microscopy and/or foot process effacement on electron microscopy), within 18 months post transplant
• 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

You may not qualify if:

• 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®

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Mallinckrodt: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

Adrenocorticotropic Hormone

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Karin True, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: March 26, 2015
• Study Start: March 1, 2021
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)