A study to test BI 764198 in people with a type of kidney disease called focal segmental glomerulosclerosis

Phase 2

Completed

• Conditions: Focal segmental glomerulosclerosis

• Registration Number: 2024-511706-23-00
• Lead Sponsor: Boehringer Ingelheim International GmbH

Brief Summary

To explore the efficacy of BI 764198 in lowering proteinuria

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-05-21
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: Ended
• Sex: Not specified
• Target Recruitment: 31

Inclusion Criteria

Signed and dated informed consent in accordance with ICH-GCP and local legislation prior to admission to the study.

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).

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, IgA-nephropathy, lupus nephritis, or monoclonal gammopathy (e.g., multiple myeloma).

Genito-urinary malformations with vesicoureteral reflux or renal dysplasia.

A history of organ transplantation or planned transplantation during the course of the study.

Uncontrolled hypertension defined as an average resting systolic blood pressure >160 mmHg calculated from the last two of the triplicate sitting blood pressure measurements at screening visit. Patients with a documented history of white coat hypertension may be included.

Concomitant use of calcineurin inhibitors within 5 half-lives before screening visit.

Concomitant treatment with cytotoxic agents (cyclophosphamide, chlorambucil), or CD20 monoclonal antibody, e.g., rituximab, within 5 half-lives before screening visit.

Treatment with metformin or dofetilide (multidrug and toxin extrusion 1 (MATE1) or organic cation transporter 2 (OCT2) substrates); dabigatran or digoxin (P-gp substrates with narrow therapeutic window) within 5 half-lives before screening visit.

Further exclusion criteria apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients achieving at least 25% reduction in 24-hour urine protein-creatinine ratio (UPCR) relative to baseline at week 12		Number of patients achieving at least 25% reduction in 24-hour urine protein-creatinine ratio (UPCR) relative to baseline at week 12

Secondary Outcome Measures

Name	Time	Method
Change in 24-hour UPCR relative to visit 3 at week 12		Change in 24-hour UPCR relative to visit 3 at week 12
Change in 24-hour UPCR relative to baseline at week 13		Change in 24-hour UPCR relative to baseline at week 13
Change in 24-hour urinary protein excretion relative to baseline at week 12		Change in 24-hour urinary protein excretion relative to baseline at week 12
Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 4		Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 4
Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 12		Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 12

Trial Locations

Locations (20)

Hospital Del Mar; 🇪🇸 Barcelona, Spain

Fundacio Puigvert; 🇪🇸 Barcelona, Spain

Hospital Clinic De Barcelona; 🇪🇸 Barcelona, Spain

Hospital Germans Trias I Pujol; 🇪🇸 Badalona, Spain

Hospital Universitario 12 De Octubre; 🇪🇸 Madrid, Spain

Hospital Universitari Vall D Hebron; 🇪🇸 Barcelona, Spain

Klinikum der Universitaet Muenchen AöR; 🇩🇪 Munich, Germany

Universitaetsklinikum Heidelberg AöR; 🇩🇪 Heidelberg, Germany

University Hospital Cologne AöR; 🇩🇪 Cologne, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hanover, Germany

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Hospital Del Mar

🇪🇸Barcelona, Spain

Eva Márquez

Site contact

+34932483000

eva.marquez.mosquera@psmar.cat