Focal Segmental GlomerulosclerosisPhase 2NCT07268638
A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
A Phase 2 study testing Praliciguat (Part A) and Praliciguat (Part B) in people with Focal Segmental Glomerulosclerosis, run by Akebia Therapeutics at 30 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Segmental Glomerulosclerosis
- What is being tested?
- Praliciguat (Part A) and Praliciguat (Part B)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 30 sitesUnited States
- Study dates
- 3 Dec 2025to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 1. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.
Who cannot join
- Collapsing FSGS in the kidney biopsy report.
- Sickle cell disease.
- HbA1c >8%.
- Uncontrolled hypertension (≥160/100 millimeters of mercury).
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
United States30 sites, 29 recruiting
- Recruiting
Investigator Site #5
Arlington, Texas, 76015
- Recruiting
Investigator Site #13
Arvada, Colorado, 80002
- Recruiting
Investigator Site #29
Augusta, Georgia, 30901
- Recruiting
Investigator Site #30
Bethlehem, Pennsylvania, 18017
- Recruiting
Investigator Site #17
Boca Raton, Florida, 33431
- Recruiting
Investigator Site #19
Bridgeville, Pennsylvania, 15017
- Recruiting
Investigator Site #22
Butler, Pennsylvania, 16001
- Recruiting
Investigator Site #4
Chattanooga, Tennessee, 37404
- Terminated
Investigator Site #3
Chicago, Illinois, 60643
- Recruiting
Investigator Site #2
Chula Vista, California, 91910
- Recruiting
Investigator Site #20
Cleveland, Ohio, 44106
- Recruiting
Investigator Site #6
Coral Springs, Florida, 33071
- Recruiting
Investigator Site #21
Dallas, Texas, 75230
- Recruiting
Investigator Site #9
Dallas, Texas, 75231
- Recruiting
Investigator Site #28
Garden Grove, California, 92844
- Recruiting
Investigator Site #23
Goose Creek, South Carolina, 29445
- Recruiting
Investigator Site #25
Hialeah, Florida, 33010
- Recruiting
Investigator Site #18
Houston, Texas, 48152
- Recruiting
Investigator Site # 1
Lawrenceville, Georgia, 30046
- Recruiting
Investigator Site #15
Livonia, Michigan, 48152
- Recruiting
Investigator Site #14
Los Angeles, California, 90022
- Recruiting
Investigator Site #11
Louisville, Kentucky, 40205
- Recruiting
Investigator Site #7
Miami, Florida, 33172
- Recruiting
Investigator Site #16
New Bern, North Carolina, 28562
- Recruiting
Investigator Site #8
Orlando, Florida, 32806
- Recruiting
Investigator Site #10
Pontiac, Michigan, 48341
- Recruiting
Investigator Site #26
Roanoke, Virginia, 24014
- Recruiting
Investigator Site #12
San Dimas, California, 91773
- Recruiting
Investigator Site #27
Valhalla, New York, 10595
- Recruiting
Investigator Site #24
Worcester, Massachusetts, 01608
About this study
Official title: 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.
- Conditions
- Focal Segmental Glomerulosclerosis
- Being tested
- Praliciguat (Part A), Placebo (Part A), Praliciguat (Part B)
- Keywords
- Glomerular Disease, Chronic Kidney Disease, Proteinuria, Urine protein-to-creatinine ratio
- Medical subject headings
- Glomerulosclerosis, Focal Segmental, Renal Insufficiency, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Praliciguat (Part A)Drug
Oral Tablet
Placebo (Part A)Other
Oral Tablet
Praliciguat (Part B)Drug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Praliciguat (Part A) | Experimental | 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. Receives: Drug: Praliciguat (Part A) |
| Placebo (Part A) | Placebo comparator | Matching placebo will be administered daily for 24 weeks Receives: Other: Placebo (Part A) |
| Experimental: Long-term safety extension praliciguat (Part B) | Experimental | Praliciguat will be administered daily Receives: Drug: Praliciguat (Part B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in urine protein-to-creatinine ratio (UPCR) (Part A)
Measured: 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)
Measured: Time Frame: Up to Week 52
Secondary outcomes (3)
Percentage of Participants with Partial Remission at Week 24 (Part A)
Partial remission is defined as 40% UPCR reduction and UPCR<1.5 gram/gram (g/g).
Measured: Up to Week 24
Plasma concentrations of praliciguat (Part A)
Measured: Week 24, Week 32, and Week 36
Incidence of TEAEs, SAEs, and AESIs in the long-term safety extension (Part B)
Measured: From Week 48 Part A through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start3 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Segmental GlomerulosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akebia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268638
- Sponsor's protocol ID
- AKB-1973-CI-0001
- Status last verified
- Sep 2026
- First submitted
- 26 Nov 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07268638
- Acronym / sponsor ID
- AKB-1973-CI-0001
- Conditions
- Focal Segmental Glomerulosclerosis
- Keywords
- Glomerular Disease, Chronic Kidney Disease, Proteinuria, Urine protein-to-creatinine ratio
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Praliciguat (Part A) | Experimental | Drug: 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 (Part A) | Placebo comparator | Other: Placebo (Part A)Matching placebo will be administered daily for 24 weeks |
| Experimental: Long-term safety extension praliciguat (Part B) | Experimental | Drug: Praliciguat (Part B)Praliciguat will be administered daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 1. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.
Key exclusion criteria (4 listed)
- Collapsing FSGS in the kidney biopsy report.
- Sickle cell disease.
- HbA1c >8%.
- Uncontrolled hypertension (≥160/100 millimeters of mercury).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Praliciguat (Part A)Oral Tablet | Drug | Praliciguat (Part A) |
| Placebo (Part A)Oral Tablet | Other | Placebo (Part A) |
| Praliciguat (Part B)Oral Tablet | Drug | Experimental: Long-term safety extension praliciguat (Part B) |
Primary outcome
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
3 secondary outcomes
Percentage of Participants with Partial Remission at Week 24 (Part A)
Time frame: Up to Week 24
Plasma concentrations of praliciguat (Part A)
Time frame: Week 24, Week 32, and Week 36
Incidence of TEAEs, SAEs, and AESIs in the long-term safety extension (Part B)
Time frame: From Week 48 Part A through study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Praliciguat (Part A) and Praliciguat (Part B) in people with Focal Segmental Glomerulosclerosis, run by Akebia Therapeutics at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akebia Therapeutics (16178446128, trials@akebia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.