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New pill shows promise for rare kidney disease in early trial

NCT ID NCT05213624

Disease control Sponsor: Boehringer Ingelheim 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new medicine, BI 764198, in 67 adults with a kidney disease called FSGS. Participants took different doses of the medicine or a placebo daily for 12 weeks. The goal was to see if the medicine could reduce protein in the urine, a sign of better kidney health. The results help researchers understand if this treatment is safe and effective for controlling the disease.

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

67 people

The number who actually took part.

Started

May 2022

Finished

Jan 2025

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 to 75 years

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: * Male and female patients 18 years to 75 years (both inclusive) of age on the day of signing informed consent. * Patients diagnosed with biopsy proven primary Focal Segmental Glomerulosclerosis (FSGS) or documented Transient Receptor Potential Cation subfamily C Member 6 (TRPC6) gene mutation causing FSGS prior to screening visit. * Urine Protein-Creatinine Ratio (UPCR) ≥ 1000 mg/g based on first morning void urine sample during screening. * Patients treated with corticosteroids must be on a stable dose for at least 4 weeks prior to screening visit with no plan to change the dose until end of trial treatment. * Patients treated with Angiotensin Converting Enzyme (ACE) inhibitors, Angiotensin II Receptor Blockers (ARBs), finerenone, aldosterone inhibitors, or Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors should be on a stable dose for at least 4 weeks prior to screening visit with no plan to change the dose until end of trial treatment. * Body Mass Index (BMI) of ≤ 40 kg/m² at screening visit. * Women of childbearing potential (WOCBP) must be willing and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the informed consent form (ICF) and in the study protocol. Further inclusion criteria apply. Exclusion criteria: * Known monogenic (with the exception of TRPC6 gene mutations) or clinical or histologic evidence of secondary FSGS. * Documented Alport syndrome, Nail Patella syndrome, diabetic nephropathy, Immunoglobulin A (IgA)-nephropathy, lupus nephritis, or monoclonal gammopathy (e.g., multiple myeloma). * Concomitant use of calcineurin inhibitors. * Concomitant treatment with cytotoxic agents (cyclophosphamide, chlorambucil), or CD20 monoclonal antibody, e.g., rituximab, within 5 half-lives before screening visit. Note: use of other immunosuppression therapies considered as standard of care may be allowed as long as the patient remains on stable dose throughout the study. * Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m² at screening visit. * Time between start of the Q-wave and end of the T-wave in an electrocardiogram interval corrected for heart rate (QTc) intervals (QT interval corrected for heart rate using the method of Fridericia - QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant electrocardiogram (ECG) findings (at the investigator's discretion) at screening visit. * Detection of graded cataract by Lens Opacities Classification System III (LOCS III) higher than NC1/NO1, C0, P0 in the slit lamp eye examination at screening visit. Planned cataract surgery during participation in the study. Patients with cataract who have undergone lens replacement are not excluded. * Women who are pregnant, nursing, or who plan to become pregnant while in the study. Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome focal segmental glomerulosclerosis

As listed by the trial registrant

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

Kidney disease, chronic

Contacts and locations

Locations

  • A.O. Policlinico Giovanni XXIII di Bari

    Bari, 70124, Italy

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Dallas Nephrology Associates Medical Clinic

    DeSoto, Texas, 75115-2011, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Dunedin Hospital

    Dunedin, 9016, New Zealand

  • Elixia Fort Lauderdale, LLC

    Fort Lauderdale, Florida, 33308, United States

  • Emory Children's Center

    Atlanta, Georgia, 30322, United States

  • Fondazione Salvatore Maugeri

    Pavia, 27100, Italy

  • Fu Yang people's Hospital

    Fuyang, 236000, China

  • Fundació Puigvert

    Barcelona, 08025, Spain

  • Griffith Health

    Southport, Queensland, 4125, Australia

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080, China

  • HOP Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • HOP Hôtel-Dieu

    Nantes, 44093, France

  • HOP Pellegrin

    Bordeaux, 33076, France

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Germans Trias i Pujol

    Badalona, 08916, Spain

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Jacobi Medical Center

    The Bronx, New York, 10461, United States

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • NANI Research, LLC

    Oak Brook, Illinois, 60523, United States

  • Nephrology Consultants, LLC

    Huntsville, Alabama, 35805, United States

  • New Zealand Clinical Research (ChristChurch)

    Christchurch, 8011, New Zealand

  • Policlinico S. Orsola-Malpighi

    Bologna, 40138, Italy

  • Prolato Clinical Research Center-Houston-68087

    Houston, Texas, 77054, United States

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029, Australia

  • Salford Royal

    Salford, M6 8HD, United Kingdom

  • Shanghai Fifth People's Hospital affiliated to Fudan University

    Shanghai, 200240, China

  • South Florida Research Institute

    Lauderdale Lakes, Florida, 33313, United States

  • St Luke's Hospital

    Bradford, BD5 0NA, United Kingdom

  • Sunshine Hospital

    AT Albans, Victoria, 3021, Australia

  • Texas Tech University Health Sciences Center-Amarillo-63885

    Amarillo, Texas, 79106, United States

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006, China

  • The First Afiliated Hospital, Sun Yet-sen University

    Guangzhou, 510080, China

  • The First People's Hospital of Nanning

    Nanning, 530000, China

  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • Tongren hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200051, China

  • Total Research Group, LLC

    Miami, Florida, 33126, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • University of California San Francisco

    San Francisco, California, 94121, United States

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitätsklinikum Köln (AöR)

    Cologne, 50937, Germany

  • Valiance Clinical Research-South Gate-67878

    South Gate, California, 90280-5219, United States

  • Valiance Clinical Research-Tarzana-68237

    Tarzana, California, 91356, United States

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Zhejiang Province People's Hospital

    Hangzhou, 310014, China

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