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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation

NCTNCT02683889 (opens ClinicalTrials.gov in a new tab)Other id17-2336
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names ACTH (corticotropin), does not test it. It appears in the title.

Overview

Status
Completed
Phase
Phase 3
Enrollment
15 participants (actual)
Sponsor
University of Colorado, Denver · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
1 Feb 2019
Primary completion
6 Jun 2024
Completion
10 Jun 2024
First posted
17 Feb 2016 (estimated)
Last update posted
1 Jul 2026
Conditions
FSGS

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022202320242025
  1. Ph 3

    Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation

    NCT02683889

    1 Feb 2019 to 10 Jun 2024

Registry summary

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

This study will evaluate the use of Acthar in patients to undergo renal transplantation and will measure the rate of FSGS recurrence.

Interventions

  • ActharDrug

Arms1

  • Experimental

    One arm

    One arm will receive acthar to measure rate of recurrence of FSGS after transplant. There are no other arms. We do have previous data that FSGS recurs in 23% of kidney transplants.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Rate of Recurrence of FSGS as Seen in Renal Transplant Biopsies Proteinuria

    Time frame · 2 years

    Registry description

    This will be studied in the renal transplant biopsies

  2. Rate of Recurrence of Proteinuria

    Time frame · 2 years

    Registry description

    By measurement of urine protein and urine creatinine ratio

Secondary outcomes(1)

  1. Renal Function After Transplantation

    Time frame · 1 year

    Registry description

    By measurement of the estimated glomerular filtration rate with patient's creatinine

Posted results

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

Primary outcome results

Primary outcomeCount of participants· 2 years

Rate of Recurrence of FSGS as Seen in Renal Transplant Biopsies Proteinuria

GroupValue (Participants)
One Arm14
Primary outcomeCount of participants· 2 years

Rate of Recurrence of Proteinuria

GroupValue (Participants)
One Arm3
Secondary and other outcome results(1)
Secondary outcome· 1 year

Renal Function After Transplantation

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
One ArmOne arm will receive acthar to measure rate of recurrence of FSGS after transplant. There are no other arms. We do have previous data that FSGS recurs in 23% of kidney transplants. Acthar: patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS0 / 151 / 151 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

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 up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * FSGS * To receive either a live donor or deceased donor kidney transplant Exclusion Criteria: * Not having FSGS

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