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New hope for FSGS: experimental drug enters Mid-Stage trial

NCT ID NCT07268638

Disease control Sponsor: Akebia Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This study tests an experimental drug called praliciguat in 60 adults with a rare kidney disease called FSGS. The goal is to see if it can reduce protein in the urine, a sign of kidney damage. Participants will first receive either the drug or a placebo for 24 weeks, then everyone can take the drug for another 24 weeks.

Why investors are watching

Akebia Therapeutics is running a Phase 2 trial of praliciguat in patients with focal segmental glomerulosclerosis (FSGS), a kidney disease with few treatment options. The trial randomizes 60 adults to receive praliciguat or a placebo for 24 weeks, then all participants receive the drug for another 24 weeks. For a small company, this readout matters because a positive result could validate praliciguat as a new treatment for a disease with high unmet need.

If it works: If the trial shows praliciguat helps patients with FSGS, Akebia could have a new product to bring to market. A positive result might also support further testing in larger trials and attract partners.

If it fails: Phase 2 trials often fail to show a benefit over placebo, and this one has only 60 participants, so the results may be inconclusive. A failure or delay could hurt Akebia's prospects, as the company depends on this drug's success.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic renal failure syndrome focal segmental glomerulosclerosis proteinuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Focal segmental glomerulosclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    24 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Investigator Site # 1

    RECRUITING

    Lawrenceville, Georgia, 30046, United States

  • Investigator Site #10

    RECRUITING

    Pontiac, Michigan, 48341, United States

  • Investigator Site #11

    RECRUITING

    Louisville, Kentucky, 40205, United States

  • Investigator Site #12

    RECRUITING

    San Dimas, California, 91773, United States

  • Investigator Site #13

    RECRUITING

    Arvada, Colorado, 80002, United States

  • Investigator Site #14

    RECRUITING

    Los Angeles, California, 90022, United States

  • Investigator Site #15

    RECRUITING

    Livonia, Michigan, 48152, United States

  • Investigator Site #16

    RECRUITING

    New Bern, North Carolina, 28562, United States

  • Investigator Site #17

    RECRUITING

    Boca Raton, Florida, 33431, United States

  • Investigator Site #18

    RECRUITING

    Houston, Texas, 48152, United States

  • Investigator Site #19

    RECRUITING

    Bridgeville, Pennsylvania, 15017, United States

  • Investigator Site #2

    RECRUITING

    Chula Vista, California, 91910, United States

  • Investigator Site #20

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Investigator Site #21

    RECRUITING

    Dallas, Texas, 75230, United States

  • Investigator Site #22

    RECRUITING

    Butler, Pennsylvania, 16001, United States

  • Investigator Site #23

    RECRUITING

    Goose Creek, South Carolina, 29445, United States

  • Investigator Site #24

    RECRUITING

    Worcester, Massachusetts, 01608, United States

  • Investigator Site #25

    RECRUITING

    Hialeah, Florida, 33010, United States

  • Investigator Site #3

    TERMINATED

    Chicago, Illinois, 60643, United States

  • Investigator Site #4

    RECRUITING

    Chattanooga, Tennessee, 37404, United States

  • Investigator Site #5

    RECRUITING

    Arlington, Texas, 76015, United States

  • Investigator Site #6

    RECRUITING

    Coral Springs, Florida, 33071, United States

  • Investigator Site #7

    RECRUITING

    Miami, Florida, 33172, United States

  • Investigator Site #8

    RECRUITING

    Orlando, Florida, 32806, United States

  • Investigator Site #9

    RECRUITING

    Dallas, Texas, 75231, United States

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