Acthar for Treatment of Post-transplant FSGS

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02399462

Collaborator

Mallinckrodt (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
FSGS Renal Transplantation Kidney Transplantation	Drug: Acthar	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Acthar for Treatment of Post-transplant FSGS

Anticipated Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Jul 31, 2021

Actual Study Completion Date :

Jul 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Drug Arm Acthar SC injections	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). Other Names: ACTH (adrenocorticotropic hormone ), corticotropin

Arm

Intervention/Treatment

Experimental: Study Drug Arm

Acthar SC injections

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).

Other Names:

ACTH (adrenocorticotropic hormone ), corticotropin

Outcome Measures

Primary Outcome Measures

number of patients with proteinuria [24 and 52 weeks]
partial and complete remission of proteinuria

Secondary Outcome Measures

Graft loss [during study period]
graft loss defined by return to dialysis, re-transplant or death during study period
eGFR change [weeks 4,8,12,16,20 and 24]
estimated Glomerular filtration rate (eGFR MDRD formula) change from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

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®

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

University of North Carolina, Chapel Hill
Mallinckrodt

Investigators

Principal Investigator: Karin True, MD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT02399462

Other Study ID Numbers:

15-0999
ACTH-101

First Posted:

Mar 26, 2015

Last Update Posted:

Aug 30, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adrenocorticotropic Hormone

Melanocyte-Stimulating Hormones

beta-Endorphin

Study Results

No Results Posted as of Aug 30, 2021