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

  • STATUS
    Recruiting
  • End date
    Feb 21, 2024
  • participants needed
    60
  • sponsor
    Boehringer Ingelheim
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Updated on 28 October 2022
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Summary

This study is open to adults with a type of kidney disease called primary 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.

Details
Condition Kidney Disease, Chronic
Treatment Placebo, BI 764198
Clinical Study IdentifierNCT05213624
SponsorBoehringer Ingelheim
Last Modified on28 October 2022

Eligibility

 Yes No Not Sure

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
Average Urine Protein-Creatinine Ratio (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 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 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 International Council on Harmonisation (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. Men must be willing and able to use condom if their partner is a WOCBP
Further inclusion criteria apply

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, 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 therapeutic dose throughout the study
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (Chronic Kidney
Disease-Epidemiology Collaboration (CKD EPI) formula based on serum creatinine and
cystatin C) at screening visit
Time between start of the Q-wave and end of the T-wave in an electrocardiogram (QT)
intervals corrected for heart rate using the method of Fridericia (QTcF) greater than
milliseconds (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 (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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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