A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
ConditionFocal Segmental Glomerulosclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAkebia Therapeutics
About this trial
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of praliciguat in adults with biopsy-confirmed focal segmental glomerulosclerosis (FSGS). Participants will be randomized 1:1 to receive praliciguat or placebo for initial 24 week treatment period. Following this double-blind period, all participants will receive praliciguat in an open-label extension for an additional 24 weeks.
Eligibility criteria
Qualifiers
UPCR ≥1 (g/g) during screening.
On maximally tolerated ACEi or ARB per principal investigator discretion within 1 month of informed consent.
Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
Kidney biopsy collected within 5 years of screening consistent with FSGS or kidney biopsy collected ≥5 years prior to screening consistent with FSGS plus the presence of a pathogenic gene mutation known to be associated with FSGS.
Disqualifiers
Collapsing FSGS in the kidney biopsy report.
Sickle cell disease.
HbA1c >8%.
Uncontrolled hypertension (≥160/100 millimeters of mercury).
Trial design
Treatments tested in this trial
- Praliciguat
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov