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

Phase 1

• Conditions: Glomerulosclerosis; MedDRA version: 21.1Level: PTClassification code 10067757Term: Focal segmental glomerulosclerosisSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2020-000384-23-ES
• Lead Sponsor: Boehringer Ingelheim España S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-28
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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.
- Average UPCR = 1500 mg/g based on two 24 hour urine samples collected at least 7 days apart at screening.
- Completion of initial corticosteroid therapy course (if applicable) or discontinuation due to intolerance before entry to the trial.
- If applicable, corticosteroid therapy (i.e. prednisone) of =15 mg/day or =30 mg on alternate days with stable dose for at least 2 weeks at randomization, with no plan to change the dose during the study.
- 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 during the study.
- 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). Men must be willing and able to use condom if their partner is a WOCBP.
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

- 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.
- 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 therapeutic dose throughout the study.
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (CKD EPI formula based on serum creatinine and cystatin C) at screening visit.
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >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.

Study & Design

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