Trial · Interventional
WithdrawnPhase 4Registry dataActhar for Treatment of Post-transplant FSGS
This trial was withdrawn before it enrolled anyone.
Reason given at the registry: Funding terminated prematurely
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- Withdrawn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
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.
number of patients with proteinuria
Time frame · 24 and 52 weeks
Registry description
partial and complete remission of proteinuria
Secondary outcomes(2)
Graft loss
Time frame · during study period
Registry description
graft loss defined by return to dialysis, re-transplant or death during study period
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
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