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Kidney Disease, ChronicPhase 2NCT05213624

A Study to Test BI 764198 in People With a Type of Kidney Disease Called Focal Segmental Glomerulosclerosis

A Phase 2 study testing BI 764198 in people with Kidney Disease, Chronic, run by Boehringer Ingelheim at 54 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is open to adults with a type of kidney disease called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 improves the health of the kidneys in people with FSGS. Three different doses of BI 764198 are tested in this study. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Kidney Disease, Chronic
What is being tested?
BI 764198
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
67 participants
Where
54 sitesin 10 countries
Study dates
3 May 2022to 3 Jan 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

54 sites in 10 countries.

54 sites in 10 countries

United States20 sites

  • Texas Tech University Health Sciences Center-Amarillo-63885

    Amarillo, Texas, 79106

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Emory Children's Center

    Atlanta, Georgia, 30322

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Dallas Nephrology Associates Medical Clinic

    DeSoto, Texas, 75115-2011

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Elixia Fort Lauderdale, LLC

    Fort Lauderdale, Florida, 33308

  • Prolato Clinical Research Center-Houston-68087

    Houston, Texas, 77054

  • Nephrology Consultants, LLC

    Huntsville, Alabama, 35805

  • South Florida Research Institute

    Lauderdale Lakes, Florida, 33313

  • Total Research Group, LLC

    Miami, Florida, 33126

  • NANI Research, LLC

    Oak Brook, Illinois, 60523

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of California San Francisco

    San Francisco, California, 94121

  • Valiance Clinical Research-South Gate-67878

    South Gate, California, 90280-5219

  • Valiance Clinical Research-Tarzana-68237

    Tarzana, California, 91356

  • Jacobi Medical Center

    The Bronx, New York, 10461

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

    Torrance, California, 90502

Other trials in United States

China8 sites

  • Fu Yang people's Hospital

    Fuyang, 236000

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • The First Afiliated Hospital, Sun Yet-sen University

    Guangzhou, 510080

  • Zhejiang Province People's Hospital

    Hangzhou, 310014

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006

  • The First People's Hospital of Nanning

    Nanning, 530000

  • Tongren hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200051

  • Shanghai Fifth People's Hospital affiliated to Fudan University

    Shanghai, 200240

Other trials in China

Spain6 sites

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Fundació Puigvert

    Barcelona, 08025

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

Other trials in Spain

Australia5 sites

  • Sunshine Hospital

    AT Albans, Victoria, 3021

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Griffith Health

    Southport, Queensland, 4125

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

France3 sites

  • HOP Pellegrin

    Bordeaux, 33076

  • HOP Bicêtre

    Le Kremlin-Bicêtre, 94270

  • HOP Hôtel-Dieu

    Nantes, 44093

Other trials in France

Germany3 sites

  • Universitätsklinikum Köln (AöR)

    Cologne, 50937

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

Other trials in Germany

Italy3 sites

  • A.O. Policlinico Giovanni XXIII di Bari

    Bari, 70124

  • Policlinico S. Orsola-Malpighi

    Bologna, 40138

  • Fondazione Salvatore Maugeri

    Pavia, 27100

Other trials in Italy

United Kingdom3 sites

  • St Luke's Hospital

    Bradford, BD5 0NA

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • Salford Royal

    Salford, M6 8HD

Other trials in United Kingdom

New Zealand2 sites

  • New Zealand Clinical Research (ChristChurch)

    Christchurch, 8011

  • Dunedin Hospital

    Dunedin, 9016

Other trials in New Zealand

Belgium1 site

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

About this study

Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Profile of BI 764198 Administered Orally Once Daily for 12 Weeks in Patients With Focal Segmental Glomerulosclerosis

This study is open to adults with a type of kidney disease called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 improves the health of the kidneys in people with FSGS. Three different doses of BI 764198 are tested in this study.

Participants are put into 4 groups randomly, which means by chance. Three of the groups receive different doses of BI 764198 and one group receives placebo. Participants are in the study for about 4 months. For about 3 months, they take BI 764198 or placebo as capsules once a day.

Read more

Placebo capsules look like BI 764198 capsules but do not contain any medicine. Participants visit the study site about 10 times. You can participate in this study from your home. In this case a research nurse will visit you for the study visits.

Kidney health is assessed based on the analysis of urine samples, which participants collect at home. At the end of the study, the results are compared between the different groups. During the study, the doctors also regularly check the general health of the participants.

Being tested
BI 764198, Placebo
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 764198Drug

    One single capsule of 20 milligrams (mg), 40 mg, or 80 mg of BI 764198 orally, once a day.

  • PlaceboDrug

    One single capsule of placebo matching BI 764198 orally, once a day.

Study groups in NCT05213624
Study groupRoleWhat they receive
BI 764198 20 mgExperimentalPatients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 20 milligrams (mg) of BI 764198 orally for 12 weeks.
Receives: Drug: BI 764198
BI 764198 40 mgExperimentalPatients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 40 milligrams (mg) of BI 764198 orally for 12 weeks.
Receives: Drug: BI 764198
BI 764198 80 mgExperimentalPatients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks.
Receives: Drug: BI 764198
PlaceboPlacebo comparatorPatients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Achievement of at Least 25% Reduction in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Baseline at Week 12

    Predicted probability of patients as a percentage - predicted percentage of patients - achieving at least 25% reduction in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at Week 12 (responders) is reported. Baseline was the average of two 24-hour urine samples collected before Visit 2 (Week 0). Patients who either missed their Week 12, 24-hour UPCR assessment or their Week 12, 24-hour UPCR assessment, occurred later than 5 days after the last dose (Residual Effect Period), were considered as non-responders.

    The predicted probability of response was calculated using a logistic regression utilizing corticosteroid use at randomization and baseline 24-hr UPCR as covariates and is presented as a percentage.

    Measured: At baseline and Week 12.

  2. Relative Change From Baseline at Week 12 of 24-hour Urine Protein Creatinine Ratio (UPCR)

    Relative change from baseline at Week 12 in 24-hour urine protein creatinine ratio (UPCR), is reported. Baseline was the average of two 24-hour urine samples collected before Visit 2 (Week 0).

    An analysis of covariance (ANCOVA) model was used to estimate the relative change in UPCR from baseline to Week 12 with corticosteroid use at randomization and baseline 24-hr UPCR as covariates.

    Measured: At baseline and at Week 12.

Secondary outcomes (4)

  1. Change in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Visit 3 at Week 12

    Median change in 24-hour urine protein creatinine ratio (UPCR) relative to Visit 3 (Week 1) at Week 12, is calculated by subtracting the 24-hour UPCR, [Week 12] - [Week 1] values per patient, then by calculating the median of these changes, per treatment group.

    Measured: At Week 1 and Week 12.

  2. Change in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Baseline at Week 13

    Median change in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at Week 13, is calculated by subtracting the 24-hour UPCR, [Week 13] - [baseline] values per patient,then by calculating the median of these changes, per treatment group. Baseline was the average of two, 24-hour urine samples collected before Visit 2 (Week 0).

    Measured: At baseline and at Week 13.

  3. Change in 24-hour Urinary Protein Excretion Relative to Baseline at Week 12

    Median change in 24-hour urinary excretion rate relative to baseline at Week 12, is calculated by subtracting the urinary excretion rate, [Week 12] - [baseline], values per patient, then by calculating the median of these changes, per treatment group. Baseline was the average of two, 24-hour urine samples collected before Visit 2 (Week 0).

    Measured: At baseline and at Week 12.

  4. Pre-dose Plasma Concentration of BI 764198 at Steady-state (Cpre,ss ) at Week 4 and Week 12

    Pre-dose Plasma Concentration of BI 764198 at steady-state (Cpre,ss ) at Week 4 and Week 12 is reported.

    Measured: At 671.917 hours and at 2015.917 hours after first drug administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2022
  2. Study start3 May 2022
  3. Primary completion3 Jan 2025
  4. Study completion3 Jan 2025

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05213624
Sponsor's protocol ID
1434-0004
Other IDs
2020-000384-23, U1111-1292-1333
Status last verified
Dec 2025
First submitted
27 Jan 2022
Last updated
12 Jan 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Publications

  • Trachtman H, Kretzler M, Gesualdo L, Cross N, Workeneh B, Kaufeld J, Meijers B, Ye Z, Chen Q, Derebail VK, Ng MSY, Ji B, Lobmeyer MT, Retlich S, Licariao Rocha FT, Prasad S, Soleymanlou N. TRPC6 inhibition for the treatment of focal segmental glomerulosclerosis: a randomised, placebo-controlled, phase 2 trial of BI 764198. Lancet. 2026 Feb 7;407(10528):587-598. doi: 10.1016/S0140-6736(25)02255-X. Epub 2026 Jan 27.

    PubMed 41616795

  • Wooden B, Beenken A, Martinelli E, Saida K, Knob AL, Ke J, Pisani I, Jin G, Lane B, Mitrotti A, Colby E, Lim TY, Guglielmi F, Osborne AJ, Ahram DF, Wang C, Armand F, Zanoni F, Bomback AS, Delsante M, Appel GB, Ferrari MRA, Martino J, Sahdeo S, Breckenridge D, Petrovski S, Paul DS, Hall G, Magistroni R, Murtas C, Feriozzi S, Rampino T, Esposito P, Helmuth ME, Sampson MG, Kretzler M, Kiryluk K, Shril S, Gesualdo L, Maggiore U, Fiaccadori E, Gbadegesin R, Santoriello D, D'Agati VD, Saleem MA, Gharavi AG, Hildebrandt F, Pollak MR, Goldstein DB, Sanna-Cherchi S. Natural History and Clinicopathological Associations of TRPC6-Associated Podocytopathy. J Am Soc Nephrol. 2025 Feb 1;36(2):274-289. doi: 10.1681/ASN.0000000501. Epub 2024 Oct 1.

    PubMed 39352759

  • Salemkour Y, Yildiz D, Dionet L, 't Hart DC, Verheijden KAT, Saito R, Mahtal N, Delbet JD, Letavernier E, Rabant M, Karras A, van der Vlag J, Nijenhuis T, Tharaux PL, Lenoir O. Podocyte Injury in Diabetic Kidney Disease in Mouse Models Involves TRPC6-mediated Calpain Activation Impairing Autophagy. J Am Soc Nephrol. 2023 Nov 1;34(11):1823-1842. doi: 10.1681/ASN.0000000000000212. Epub 2023 Sep 6.

    PubMed 37678257

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 764198 in people with Kidney Disease, Chronic, run by Boehringer Ingelheim at 54 sites in 10 countries.

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 8 inclusion and 9 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: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, China, Spain, Australia, France and 5 more countries. 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?

Yes. Results are posted in the registry (first posted 12 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achievement of at Least 25% Reduction in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Baseline at Week 12 (time frame: At baseline and Week 12.). 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?

On the ClinicalTrials.gov record for NCT05213624, which also lists 3 linked publications.

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 12 Jan 2026.

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