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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02683889
Recruitment Status : Recruiting
First Posted : February 17, 2016
Last Update Posted : November 4, 2016
Information provided by (Responsible Party):
Georgetown University

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

Condition or disease Intervention/treatment Phase
FSGS Drug: Acthar Phase 3

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Study Start Date : August 2016
Estimated Primary Completion Date : August 2020

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

Primary Outcome Measures :
  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 Outcome Measures :
  1. renal function after transplantation [ Time Frame: 1 year ]
    By measurement of the estimated glomerular filtration rate with patient's creatinine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Not having FSGS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02683889

Contact: Monica Grafals, MD, MPH 2024443700

United States, District of Columbia
Medstar Georgetown Transplant Institute Recruiting
Washington, District of Columbia, United States, 20005
Contact: Monica Grafals, MD, MPH    202-444-3700      
Sponsors and Collaborators
Georgetown University

Responsible Party: Georgetown University Identifier: NCT02683889     History of Changes
Other Study ID Numbers: 2015-0797
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Kidney Diseases
Urologic Diseases
Adrenocorticotropic Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs