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

FSGS Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02683889
• Other study ID #: 17-2336
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 1, 2019
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• FSGS

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

Exclusion Criteria:

• Not having FSGS

Related Conditions & MeSH terms

• FSGS

Intervention

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

Locations

Country	Name	City	State
United States	Medstar Georgetown Transplant Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recurrence of FSGS as seen in renal transplant biopsies proteinuria	This will be studied in the renal transplant biopsies	2 years
Primary	Rate of recurrence of proteinuria	By measurement of urine protein and urine creatinine ratio	2 years
Secondary	renal function after transplantation	By measurement of the estimated glomerular filtration rate with patient's creatinine	1 year