FSGS Therapy Using Sparsentan – Phase III

The Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis

Protocol Description

In this multi-center international study, researchers are evaluating the drug sparsentan to see if it is effective in lowering the amount of protein in urine caused by primary focal segmental glomerulosclerosis (FSGS), a rare disease affecting the kidneys. FSGS causes scarring in parts of the kidney that filter waste materials from blood, allowing protein to leak into the urine, a condition called proteinuria. If the protein leaks for too long, it can lead to kidney failure. The study compares the effects of sparsentan to irbesartan, a drug that is used to treat adults with proteinuria.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is accepting participants, ages 8 and older, who have FSGS.
Males and Females: Ages 8 through adult


Following a screening period of up to 6 weeks, participants will be randomly assigned to take either sparsentan or irbesartan in capsule form. The treatment period is 108 weeks during which time they will return to the study center for 14 visits for examinations, blood and urine sampling, and to complete quality of life questionnaires. There will be additional visits at the end of treatment and for follow-up.
Visits: Up to 17
Duration: 2 years, 6 months

Status: Open to Enrollment

Source(s) of Support


Primary Investigator

Michael Moritz, MD

Contact Information

For more information about the study or enrollment, please contact:
Vibha Chauhan, PhD, CCRP, CCRC