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
This trial does not accept healthy volunteersQualifiers
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 within 3 years of screening consistent with FSGS or documentation of a genetic mutation in a podocyte protein associated with FSGS.
Disqualifiers
Collapsing FSGS in the kidney biopsy report.
Sickle cell disease.
HbA1c >8% or non-fasting blood glucose >180 milligram/decilitre.
Uncontrolled hypertension (≥160/100 millimeters of mercury)
Trial design
Design model
Parallel
Treatments tested in this trial
Praliciguat
DrugOral Tablet
Placebo
Other interventionOral Tablet
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: PraliciguatExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in urine protein-to-creatinine ratio (UPCR)
Time frame
Baseline (Day 1) and up to Week 24Secondary outcomes
1
Percentage of Participants with Partial Remission at Week 24
Partial remission is defined as 40% UPCR reduction and UPCR\<1.5 gram/gram (g/g).
Time frame
Up to Week 24Sponsors and contacts
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Source ClinicalTrials.gov