Tests praliciguat in people with a kidney disease called focal segmental glomerulosclerosis
Tests praliciguat or a placebo in adults with a kidney scarring disease called FSGS.
Plain-language title generated from the registry record
Registry title: A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
Key facts
- Where
- Arlington, Arvada, Augusta, Bethlehem, Boca Raton, Bridgeville, Butler, Catonsville, Chattanooga, Chicago, Chula Vista, Cleveland, Coral Springs, Dallas, Garden Grove, Goose Creek, Hialeah, Houston, Lawrenceville, Livonia, Los Angeles, Louisville, Miami, New Bern, Orlando, Pontiac, Roanoke, San Dimas, Shelby, Valhalla, and Worcester, United StatesSee the 32 sites
- Phase
- Phase 2
Where in United States
- ArlingtonArlington, United StatesTaking people
- ArvadaArvada, United StatesTaking people
- AugustaAugusta, United StatesTaking people
- BethlehemBethlehem, United StatesTaking people
- Boca RatonBoca Raton, United StatesTaking people
- BridgevilleBridgeville, United StatesTaking people
- ButlerButler, United StatesTaking people
- CatonsvilleCatonsville, United StatesTaking people
- ChattanoogaChattanooga, United StatesTaking people
- ChicagoChicago, United StatesNo longer taking part
- Chula VistaChula Vista, United StatesTaking people
- ClevelandCleveland, United StatesTaking people
- Coral SpringsCoral Springs, United StatesTaking people
- DallasDallas, United StatesTaking people
- DallasDallas, United StatesTaking people
- Garden GroveGarden Grove, United StatesTaking people
- Goose CreekGoose Creek, United StatesTaking people
- HialeahHialeah, United StatesTaking people
- HoustonHouston, United StatesTaking people
- LawrencevilleLawrenceville, United StatesTaking people
- LivoniaLivonia, United StatesTaking people
- Los AngelesLos Angeles, United StatesTaking people
- LouisvilleLouisville, United StatesTaking people
- MiamiMiami, United StatesTaking people
- New BernNew Bern, United StatesTaking people
- OrlandoOrlando, United StatesTaking people
- PontiacPontiac, United StatesTaking people
- RoanokeRoanoke, United StatesTaking people
- San DimasSan Dimas, United StatesTaking people
- ShelbyShelby, United StatesTaking people
- ValhallaValhalla, United StatesTaking people
- WorcesterWorcester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Akebia Therapeutics
- Trial code
- NCT07268638
- Record updated
- 9 November 2026
- Original description
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 period for an additional 24 weeks. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.Read full original descriptionShow less
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Praliciguat in Patients With Biopsy-Confirmed Focal Segmental Glomerulosclerosis
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 period for an additional 24 weeks. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.
Inclusion: 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; Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.
Exclusion: Sickle cell disease; Uncontrolled hypertension (≥160/100 millimeters of mercury); HbA1c >8%; Collapsing FSGS in the kidney biopsy report.