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New drug aims to plug kidney leaks in multiple diseases

NCT ID NCT04573920

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tests the drug atrasentan in 103 adults with various kidney diseases that cause protein leakage, including IgA nephropathy and FSGS. Participants take a daily tablet to see if it reduces protein in urine, a sign of kidney damage. The goal is to find a new way to slow disease progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atrasentan
What this could lead to
If successful, this could point toward a new treatment option to slow kidney damage in several proteinuric glomerular diseases.
What could go wrong
This is an early-phase, open-label study with no placebo group, so results may not be definitive. The drug may not work for all conditions tested or could have side effects.

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

103 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Oct 2026

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: * Age 18 years and older for patients in the IgAN, FSGS, and Alport Syndrome cohorts * Age 18-70 years for patients in the DKD cohort * Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks. * For patients enrolling in IgAN Cohort: 1. Biopsy-proven IgA nephropathy 2. UPCR between 0.5 to less than 1.0 g/g 3. Screening eGFR ≥ 30 mL/min/1.73 m2 * For patients enrolling in FSGS Cohort: 1. Biopsy-proven FSGS or documented genetic mutation in a podocyte protein associated with FSGS 2. UPCR \> 1.0 g/g 3. Screening eGFR ≥ 30 mL/min/1.73 m2 4. Subjects receiving systemic corticosteroids or other immunosuppressants must be on a stable dose for at least 12 weeks. 5. BMI ≤ 40 kg/m2 * For patients enrolling in Alport syndrome Cohort: 1. Diagnosis of Alport syndrome by genetic testing 2. UPCR \> 0.5 g/g 3. Screening eGFR ≥ 30 mL/min/1.73 m2 * For patients enrolling in DKD Cohort: 1. Diagnosis of type 2 diabetes mellitus 2. UACR ≥ 0.5 g/g 3. Screening eGFR ≥ 45 mL/min/1.73 m2 4. Receiving a stable dose of SGLT2 inhibitor for at least 12 weeks * Willing and able to provide informed consent and comply with all study requirements Exclusion Criteria: * Current diagnosis of another cause of chronic kidney disease or another primary glomerulopathy. * History of kidney transplantation or other organ transplantation. * Except for FSGS patients, use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months. * Blood pressure above 150 mmHg systolic or 95 mmHg diastolic as evaluated by the Investigator. * History of heart failure or a previous hospital admission for fluid overload. * Clinically significant history of liver disease as assessed by the Investigator. * Hemoglobin below 9 g/dL as measured by the Investigator or blood transfusion for anemia within the past 3 months. * Clinical diagnosis of nephrotic syndrome * Malignancy within the past 5 years. Exception to the criteria include nonmelanoma skin cancer and curatively treated cervical carcinoma in situ. * For women, pregnant, breastfeeding, or intent to become pregnant during the study. * For men, intent to father a child or donate sperm during the study. * Recently received an investigational agent. * Clinically significant unstable or uncontrolled medical condition as assessed by the Investigator.

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Conditions

The condition(s) this trial relates to.

Alport syndrome diabetic kidney disease focal segmental glomerulosclerosis hereditary nephritis IgA glomerulonephritis

As listed by the trial registrant

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

Alport syndrome Diabetic kidney disease Diabetic nephropathy type 2 Focal segmental glomerulosclerosis IgA nephropathy Immunoglobulin A nephropathy

Contacts and locations

Locations

  • Academic Medical Research Institute

    Los Angeles, California, 90022, United States

  • Baylor Scott and White

    Dallas, Texas, 75246, United States

  • Brookview Hills Research Assoc

    Winston-Salem, North Carolina, 27103, United States

  • Colorado Kidney Care Nephrology

    Denver, Colorado, 80230, United States

  • DaVita Clinical Research

    Las Vegas, Nevada, 89146, United States

  • Kidney Disease Medical Group

    Glendale, California, 91206, United States

  • Milwaukee Nephrologists SC

    Wauwatosa, Wisconsin, 53226, United States

  • Mountain Kidney And Hyper Associa

    Asheville, North Carolina, 28801, United States

  • North America Research Institute

    San Dimas, California, 91773, United States

  • Northwest Louisiana Nephrology Research

    Shreveport, Louisiana, 71101-4440, United States

  • Novartis Investigative Site

    Gosford, New South Wales, 2250, Australia

  • Novartis Investigative Site

    Herston, Queensland, 4029, Australia

  • Novartis Investigative Site

    Clayton, Victoria, 3168, Australia

  • Novartis Investigative Site

    Reservoir, Victoria, 3073, Australia

  • Novartis Investigative Site

    St Albans, Victoria, 3021, Australia

  • Novartis Investigative Site

    St Leonards, 2065, Australia

  • Novartis Investigative Site

    Roma, RM, 00165, Italy

  • Novartis Investigative Site

    Cheonan, Chungcheongnam-do, 330-721, South Korea

  • Novartis Investigative Site

    Anyang-si, Gyeonggi-do, 14068, South Korea

  • Novartis Investigative Site

    Seoul, Korea, 02841, South Korea

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Seoul, 134 727, South Korea

  • Novartis Investigative Site

    Port de Sagunt, Valencia, 46520, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Lugo, 27004, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Majadahonda, 28222, Spain

  • Novartis Investigative Site

    Sheffield, South Yorkshire, S10 2JF, United Kingdom

  • Novartis Investigative Site

    London, E1 1BB, United Kingdom

  • Prolato Clinical Research Center

    Houston, Texas, 77054, United States

  • Stanford U School Of Medicine

    Stanford, California, 94305, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • Uni of Minnesota Hos and Clinics

    Minneapolis, Minnesota, 55455, United States

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Other studies related to the condition(s) this trial covers.