Recruiting
Phase 2

Praliciguat

Sponsor:

Akebia Therapeutics

Code:

NCT07268638

Conditions

Focal Segmental Glomerulosclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Praliciguat (Part A)

Placebo (Part A)

Praliciguat (Part B)

Study Details

Brief summary:

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.

Conditions

Focal Segmental Glomerulosclerosis

Study ID

NCT07268638

Start date

Dec 3, 2025

Status verified date

Sep, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria (Part A):

1. UPCR ≥1 (g/g) during screening.
2. On maximally tolerated ACEi or ARB per principal investigator discretion within 1 month of informed consent.
3. Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
4. 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.

Exclusion Criteria (Part A):

1. Collapsing FSGS in the kidney biopsy report.
2. Sickle cell disease.
3. HbA1c >8%.
4. Uncontrolled hypertension (≥160/100 millimeters of mercury).

Inclusion Criteria (Part B):

1\. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Praliciguat (Part A)

Praliciguat will be administered daily with dose escalation to a target dose during a 24-week double-blind period, followed by a 24-week open-label treatment period.

placebo comparator: Placebo (Part A)

Matching placebo will be administered daily for 24 weeks

experimental: Experimental: Long-term safety extension praliciguat (Part B)

Praliciguat will be administered daily

Interventions

Praliciguat (Part A)

Oral Tablet

Placebo (Part A)

Oral Tablet

Praliciguat (Part B)

Oral Tablet

Primary outcome measure

  • Change from Baseline in urine protein-to-creatinine ratio (UPCR) (Part A) [ Time Frame: Baseline (Day 1) and up to Week 24 ]
  • Proportion of participants with TEAEs, serious adverse events (SAEs), and treatment-emergent adverse events of special interest (AESIs). (Part A) [ Time Frame: Time Frame: Up to Week 52 ]

Central Contacts and Locations

Central contacts

Akebia Therapeutics

16178446128trials@akebia.com

Locations

Investigator Site #2

Recruiting

Chula Vista, California, United States, 91910

Investigator Site #28

Recruiting

Garden Grove, California, United States, 92844

Investigator Site #14

Recruiting

Los Angeles, California, United States, 90022

Investigator Site #12

Recruiting

San Dimas, California, United States, 91773

Investigator Site #13

Recruiting

Arvada, Colorado, United States, 80002

Investigator Site #17

Recruiting

Boca Raton, Florida, United States, 33431

Investigator Site #6

Recruiting

Coral Springs, Florida, United States, 33071

Investigator Site #25

Recruiting

Hialeah, Florida, United States, 33010

Investigator Site #7

Recruiting

Miami, Florida, United States, 33172

Investigator Site #8

Recruiting

Orlando, Florida, United States, 32806

Investigator Site #29

Recruiting

Augusta, Georgia, United States, 30901

Investigator Site # 1

Recruiting

Lawrenceville, Georgia, United States, 30046

Investigator Site #11

Recruiting

Louisville, Kentucky, United States, 40205

Investigator Site #24

Recruiting

Worcester, Massachusetts, United States, 01608

Investigator Site #15

Recruiting

Livonia, Michigan, United States, 48152

Investigator Site #10

Recruiting

Pontiac, Michigan, United States, 48341

Investigator Site #27

Recruiting

Valhalla, New York, United States, 10595

Investigator Site #16

Recruiting

New Bern, North Carolina, United States, 28562

Investigator Site #20

Recruiting

Cleveland, Ohio, United States, 44106

Investigator Site #30

Recruiting

Bethlehem, Pennsylvania, United States, 18017

Investigator Site #19

Recruiting

Bridgeville, Pennsylvania, United States, 15017

Investigator Site #22

Recruiting

Butler, Pennsylvania, United States, 16001

Investigator Site #23

Recruiting

Goose Creek, South Carolina, United States, 29445

Investigator Site #4

Recruiting

Chattanooga, Tennessee, United States, 37404

Investigator Site #5

Recruiting

Arlington, Texas, United States, 76015

Investigator Site #21

Recruiting

Dallas, Texas, United States, 75230

Investigator Site #9

Recruiting

Dallas, Texas, United States, 75231

Investigator Site #18

Recruiting

Houston, Texas, United States, 48152

Investigator Site #26

Recruiting

Roanoke, Virginia, United States, 24014

More Information

Sponsor

Akebia Therapeutics

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • Glomerular Disease
  • Chronic Kidney Disease
  • Proteinuria
  • Urine protein-to-creatinine ratio

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Akebia Therapeutics on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.