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Clinical trial

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

ID
Name
17-2336
Description
This study will evaluate the use of Acthar in patients to undergo renal transplantation and will measure the rate of FSGS recurrence.
Trial arms
Trial start
2019-02-01
Estimated PCD
2024-06-01
Trial end
2024-06-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Acthar
patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS
Arms:
One arm
Size
20
Primary endpoint
Rate of recurrence of FSGS as seen in renal transplant biopsies proteinuria
2 years
Rate of recurrence of proteinuria
2 years
Eligibility criteria
Inclusion Criteria: * FSGS * To receive either a live donor or deceased donor kidney transplant Exclusion Criteria: * Not having FSGS
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2024-04-08

1 organization

1 product

1 indication

Organization
University of Colorado Denver
Product
Acthar
Indication
Focal Segmental Glomerulosclerosis