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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT02683889

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Feb 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rate of recurrence of FSGS as seen in renal transplant biopsies proteinuria [2 years]
This will be studied in the renal transplant biopsies
Rate of recurrence of proteinuria [2 years]
By measurement of urine protein and urine creatinine ratio

Secondary Outcome Measures

renal function after transplantation [1 year]
By measurement of the estimated glomerular filtration rate with patient's creatinine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Not having FSGS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medstar Georgetown Transplant Institute	Washington	District of Columbia	United States	20005

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator: Monica B Grafals, MD, MPH, University of Colorado, Denver

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Apr 7, 2015

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT02683889

Other Study ID Numbers:

17-2336

First Posted:

Feb 17, 2016

Last Update Posted:

Dec 14, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Colorado, Denver

Kidney transplant

Study Results

No Results Posted as of Dec 14, 2020