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

The Use of Acthar (ACTH) in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Have Developed Chronic Kidney Disease Stage V (CKD) or End Stage Renal Disease (ESRD) and Are Undergoing a Renal Transplant

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

Study Overview

• Status: Completed
• Conditions: FSGS
• Intervention / Treatment: Drug: Acthar

Detailed Description

This is a prospective study enrolling renal transplant recipients with the primary native kidney disease of FSGS.

Primary endpoint is rate of recurrence of FSGS as seen in renal transplant biopsies and in rate of proteinuria. Secondary endpoint is renal function after transplantation The target subject number is 20 patients and the target population is primary FSGS patients. By the current data, FSGS should recur in 23% of patients. Therefore, it would be expected that at least 4 patients will develop recurrent FSGS after renal transplantation.

Screening will be performed by the Principal Investigator during the kidney transplant evaluation clinics and during the wait list kidney transplant evaluation clinic. All patients with FSGS will have maintenance immunosuppression with belatacept (if EBV positive), prograf, cellcept and prednisone. If after one year the patient has been stable and there has not been rejection, will stop the prograf and continue solely with belatacept, cellcept and prednisone.

Dosage and Administration of Acthar The dose of acthar to be given to every enrolled patient will be 80 units twice a week for 6 months.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20005
      • MedStar Georgetown Transplant Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Not having FSGS

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Acthar; patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal Function After Transplantation	By measurement of the estimated glomerular filtration rate with patient's creatinine	1 year

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Sixto Giusti, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): June 6, 2024
• Study Completion (Actual): June 10, 2024

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (Estimated): February 17, 2016

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Kidney transplant
• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Pituitary Hormones; Pituitary Hormones, Anterior; Melanocortins; Pro-Opiomelanocortin; Adrenocorticotropic Hormone
• Other Study ID Numbers: 17-2336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No