Focal Segmental Glomerulosclerosis study: Praliciguat
Official title A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
ClinicalTrials.gov ID: NCT07268638
What this study is testing
What is Praliciguat?
An investigational oral tablet being studied as a potential treatment for focal segmental glomerulosclerosis (FSGS). It is designed to stimulate soluble guanylate cyclase, which may help improve kidney function.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether praliciguat can improve kidney function and safety in adults with FSGS. It compares the drug to a pretend treatment and then gives everyone the drug afterward.
- Who it's for
- You may be able to join if you are an adult with biopsy-confirmed FSGS and meet the study’s health criteria.
- What's involved
- You will take a pill every day for 24 weeks, then all participants will take the same pill for another 24 weeks. You will have regular check‑ins and tests to track your kidney health.
- Time commitment
- The study lasts about 48 weeks, with visits every few weeks to monitor your health and take tests.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)...
- Kidney biopsy collected within 5 years of screening consistent with FSGS or kidney biopsy collected ≥5 years prior to screening consistent with FSGS...
You likely can't join if
- Collapsing FSGS in the kidney biopsy report.
- Sickle cell disease.
- HbA1c \>8%.
- Uncontrolled hypertension (≥160/100 millimeters of mercury). Inclusion Criteria (Part B): 1\.
The study team makes the final eligibility decision.
Where it is enrolling
- Chula Vista, California, United States
- Garden Grove, California, United States
- Los Angeles, California, United States
- San Dimas, California, United States
- Arvada, Colorado, United States
- Boca Raton, Florida, United States
- Coral Springs, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Augusta, Georgia, United States
- Lawrenceville, Georgia, United States
- Louisville, Kentucky, United States
- Catonsville, Maryland, United States
- Worcester, Massachusetts, United States
- Livonia, Michigan, United States
- Pontiac, Michigan, United States
- Valhalla, New York, United States
- New Bern, North Carolina, United States
- Shelby, North Carolina, United States
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chula Vista, California, United States; Garden Grove, California, United States; Los Angeles, California, United States; San Dimas, California, United States; Arvada, Colorado, United States; Boca Raton, Florida, United States and 24 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.