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Trial record 1 of 1 for:    NCT02683889
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Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation

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ClinicalTrials.gov Identifier: NCT02683889
Recruitment Status : Recruiting
First Posted : February 17, 2016
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
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
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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



Information from the National Library of Medicine

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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02683889


Contacts
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Contact: Monica Grafals, MD, MPH 720 848 2237 MONICA.GRAFALS@CUANSCHUTZ.EDU

Locations
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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
University of Colorado, Denver
Investigators
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Principal Investigator: Monica B Grafals, MD, MPH University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02683889    
Other Study ID Numbers: 17-2336
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Kidney transplant