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

Kidney Disease, Chronic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05213624
• Other study ID #: 1434-0004
• Secondary ID: 2020-000384-23U1
• Status: Recruiting
• Phase: Phase 2
• Start date: March 10, 2022
• Est. completion date: February 21, 2025

Study information

• Verified date: March 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 21, 2025
• Est. primary completion date: January 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 critaria:

• 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.

Related Conditions & MeSH terms

• Glomerulosclerosis, Focal Segmental
• Kidney Disease, Chronic
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• BI 764198
BI 764198
• Placebo
Placebo matching BI 764198

Locations

Country	Name	City	State
Australia	Sunshine Hospital	AT Albans	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Griffith Health	Southport	Queensland
Australia	Westmead Hospital	Westmead	New South Wales
Belgium	UZ Leuven	Leuven
China	Fu Yang people's Hospital	Fuyang
China	Guangdong Provincial People's Hospital	Guangzhou
China	The First Afiliated Hospital, Sun Yet-sen University	Guangzhou
China	Zhejiang Province People's Hospital	Hangzhou
China	The First Affiliated Hospital of Nanchang University	Nanchang
China	The First People's Hospital of Nanning	Nanning
China	Shanghai Fifth People's Hospital affiliated to Fudan University	Shanghai
China	Tongren hospital, Shanghai Jiaotong University School of Medicine	Shanghai
France	HOP Pellegrin	Bordeaux
France	HOP Michallon	La Tronche
France	HOP Bicêtre	Le Kremlin-Bicêtre
France	HOP la Conception	Marseille
France	HOP Hôtel-Dieu	Nantes
Germany	Universitätsklinikum Essen AöR	Essen
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Universitätsklinikum Köln (AöR)	Köln
Germany	Klinikum der Universität München AÖR	München
Ireland	Beaumont Hospital	Dublin
Italy	A.O. Policlinico Giovanni XXIII di Bari	Bari
Italy	Policlinico S. Orsola Malpighi	Bologna
Italy	Fondazione Salvatore Maugeri	Pavia
New Zealand	New Zealand Clinical Research (ChristChurch)	Christchurch
New Zealand	Dunedin Hospital	Dunedin
Spain	Hospital Germans Trias i Pujol	Badalona
Spain	Fundació Puigvert	Barcelona
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
United Kingdom	St Luke's Hospital	Bradford
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Salford Royal Hospital	Salford
United States	Texas Tech University Health Sciences Center	Amarillo	Texas
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Emory Children's Center	Atlanta	Georgia
United States	Jacobi Medical Center	Bronx	New York
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Dallas Nephrology Associates Medical Clinic	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	MedResearch, Inc.	El Paso	Texas
United States	Elixia Fort Lauderdale, LLC	Fort Lauderdale	Florida
United States	Prolato Clinical Research Center	Houston	Texas
United States	Nephrology Consultants, LLC	Huntsville	Alabama
United States	South Florida Research Institute	Lauderdale Lakes	Florida
United States	Marshfield Medical Center	Marshfield	Wisconsin
United States	Total Research Group, LLC	Miami	Florida
United States	NANI Research, LLC	Oak Brook	Illinois
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	St. Clair Nephrology Research, LLC	Roseville	Michigan
United States	Valiance Clinical Research	S. Gate	California
United States	University of California San Francisco	San Francisco	California
United States	Valiance Clinical Research	Tarzana	California
United States	The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  China,  France,  Germany,  Ireland,  Italy,  New Zealand,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients achieving at least 25% reduction in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at week 12		up to 12 weeks
Secondary	Change in 24-hour UPCR relative to visit 3 at week 12		up to 12 weeks
Secondary	Change in 24-hour UPCR relative to baseline at week 13		up to 13 weeks
Secondary	Change in 24-hour urinary protein excretion relative to baseline at week 12		up to 12 weeks
Secondary	If feasible: Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 4		up to 4 weeks
Secondary	If feasible: Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 12		up to 12 weeks

External Links

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