Acthar for Treatment of Post-transplant FSGS | NCT02399462

Studies
Acthar for Treatment of Post-transplant FSGS

NCT02399462

Sponsor

University of North Carolina, Chapel Hill

Status

Withdrawn

Last Update Posted

Aug 30, 2021Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

FSGS
Renal Transplantation
Kidney Transplantation

Interventions

Acthar

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ACTH-101	Other Identifier	UNC

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding terminated prematurely

Expanded Access Info

Start Date

Mar 2021Estimated

Primary Completion Date

Jul 31, 2021Actual

Completion Date

Jul 31, 2021Actual

First Submitted Date

Jan 8, 2015

First Submission Date that Met QC Criteria

Mar 20, 2015

First Posted Date

Mar 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2021

Last Update Posted Date

Aug 30, 2021Actual

Name	Class
Mallinckrodt	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Drug Arm	Experimental	Acthar SC injections	Drug: Acthar

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of patients with proteinuria	partial and complete remission of proteinuria	24 and 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Graft loss	graft loss defined by return to dialysis, re-transplant or death during study period	during study period
eGFR change	estimated Glomerular filtration rate (eGFR MDRD formula) change from baseline

Other Outcomes

Not provided

Eligibility Module

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®

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D053486	Melanocortins
D011333	Pro-Opiomelanocortin
D007028	Hypothalamic Hormones
D036361	Peptide Hormones