NCT02683889

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
3 years until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 23, 2026

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

5.3 years

First QC Date

February 5, 2016

Results QC Date

October 7, 2024

Last Update Submit

March 19, 2026

Conditions

FSGS

Keywords

Kidney transplant

Outcome Measures

Primary Outcomes (2)

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

    This will be studied in the renal transplant biopsies

    2 years

  • Rate of Recurrence of Proteinuria

    By measurement of urine protein and urine creatinine ratio

    2 years

Secondary Outcomes (1)

  • Renal Function After Transplantation

    1 year

Study Arms (1)

One arm

EXPERIMENTAL

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.

Drug: Acthar

Interventions

ActharDRUG

patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS

One arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • FSGS
  • To receive either a live donor or deceased donor kidney transplant

You may not qualify if:

  • Not having FSGS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medstar Georgetown Transplant Institute

Washington D.C., District of Columbia, 20005, United States

Location

MeSH Terms

Interventions

Adrenocorticotropic Hormone

Intervention Hierarchy (Ancestors)

MelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Results Point of Contact

Title
Assistant Director of Transplant Clinical Research
Organization
University of Colorado Denver Anschutz Medical Campus
ivan.2.rodriguez@cuanschutz.edu
3037246446

Study Officials

  • Sixto Giusti, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 17, 2016

Study Start

February 1, 2019

Primary Completion

June 6, 2024

Study Completion

June 10, 2024

Last Updated

March 23, 2026

Results First Posted

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)