Glomerulosclerosis MedDRA version: 21.1 Level: PT Classification code 10067757 Term: Focal segmental glomerulosclerosis System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Sponsors
Boehringer Ingelheim International GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 FSGS or documented TRPC6 gene mutation causing FSGS prior to screening visit. - 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 ACE inhibitors, ARBs, finerenone, aldosterone inhibitors, or 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
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). - 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. 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) 3X the upper limit of normal (ULN) at screening visit. - QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator’s discretion) at screening visit. - Detection of graded cataract by 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 criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A key objective of this trial is to explore the efficacy of 3 doses (20 mg, 40 mg, and 80 mg) of BI 764198 with respect to their effect in lowering proteinuria. The primary endpoint is the proportion of patients achieving at least 25% reduction in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at week 12 in patients with primary FSGS, and patients with monogenic FSGS as a result of TRPC6 mutations causing FSGS. Additional objectives in this study are to investigate the safety, tolerability, and pharmacokinetic and pharmacodynamic profiles of BI 764198 vs placebo.;Secondary Objective: Not applicable;Primary end point(s): 1) Patients achieving at least 25% reduction in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at week 12.;Timepoint(s) of evaluation of this end point: 1) 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change in 24-hour UPCR relative to visit 3 at week 12 2) Change in 24-hour UPCR relative to baseline at week 13 3) Change in 24-hour urinary protein excretion relative to baseline at week 12 4) The following pharmacokinetic parameters of BI 764198 will be determined if feasible: - Steady state trough concentration Cpre,ss on week 4 and week 12;Timepoint(s) of evaluation of this end point: 1) week 12 2) week 13 3) week 12 4) weeks 4 and 12 | — |
Countries
Australia, Belgium, China, France, Germany, Ireland, Italy, New Zealand, Spain, United Kingdom, United States
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed