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Trial · Interventional

WithdrawnPhase 4Registry data

Acthar for Treatment of Post-transplant FSGS

NCTNCT02399462 (opens ClinicalTrials.gov in a new tab)Other id15-0999Other idACTH-101

Overview

Status
Withdrawn
Phase
Phase 4
Enrollment
0 participants (actual)
Sponsor
University of North Carolina, Chapel Hill · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Mar 2021 (estimated)
Primary completion
31 Jul 2021
Completion
31 Jul 2021
First posted
26 Mar 2015 (estimated)
Last update posted
30 Aug 2021
Conditions
FSGS · Renal Transplantation · Kidney Transplantation

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20212022
  1. Ph 4

    Acthar for Treatment of Post-transplant FSGS

    NCT02399462

    est. Mar 2021 to 31 Jul 2021

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ActharDrug

Arms1

  • Experimental

    Study Drug Arm

    Acthar SC injections

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. number of patients with proteinuria

    Time frame · 24 and 52 weeks

    Registry description

    partial and complete remission of proteinuria

Secondary outcomes(2)
  1. Graft loss

    Time frame · during study period

    Registry description

    graft loss defined by return to dialysis, re-transplant or death during study period

  2. eGFR change

    Time frame · weeks 4,8,12,16,20 and 24

    Registry description

    estimated Glomerular filtration rate (eGFR MDRD formula) change from baseline

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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®

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