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Completed

NCT Number: NCT02683889

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

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

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Key information

Conditions

FSGS

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medstar Georgetown Transplant Institute

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not having FSGS

Treatment and study plan

ACTHar

Drug

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

Primary outcomes

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

    Time frame: 2 years

    This will be studied in the renal transplant biopsies

  2. Rate of Recurrence of Proteinuria

    Time frame: 2 years

    By measurement of urine protein and urine creatinine ratio

Secondary outcomes

  1. Renal Function After Transplantation

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 17, 2016
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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