A Study to Test BI 764198 in People With a Type of Kidney Disease Called Primary Focal Segmental Glomerulosclerosis
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|ClinicalTrials.gov Identifier: NCT05213624|
Recruitment Status : Recruiting
First Posted : January 28, 2022
Last Update Posted : March 21, 2023
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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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Disease, Chronic||Drug: BI 764198 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||March 10, 2022|
|Estimated Primary Completion Date :||January 22, 2025|
|Estimated Study Completion Date :||February 21, 2025|
Experimental: BI 764198 - low dose
BI 764198 - low dose
Drug: BI 764198
Experimental: BI 764198 - medium dose
BI 764198 - medium dose
Drug: BI 764198
Experimental: BI 764198 - high dose
BI 764198 - high dose
Drug: BI 764198
Placebo Comparator: Placebo
Placebo matching BI 764198
- Number of patients achieving at least 25% reduction in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at week 12 [ Time Frame: up to 12 weeks ]
- Change in 24-hour UPCR relative to visit 3 at week 12 [ Time Frame: up to 12 weeks ]
- Change in 24-hour UPCR relative to baseline at week 13 [ Time Frame: up to 13 weeks ]
- Change in 24-hour urinary protein excretion relative to baseline at week 12 [ Time Frame: up to 12 weeks ]
- If feasible: Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 4 [ Time Frame: up to 4 weeks ]
- If feasible: Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 12 [ Time Frame: up to 12 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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 (WOCBP1) 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 protocol. Men must be willing and able to use condom if their partner is a WOCBP.
- 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).
- 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.
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.
- Treatment with metformin or dofetilide (Multidrug and Toxin Extrusion 1 (MATE1) or Organic Cation Transporter 2 (OCT2) substrates); dabigatran or digoxin (Permeability Glycoprotein (P-gp) substrates with narrow therapeutic window) within 5 half-lives before screening visit.
Further exclusion criteria apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05213624
|Contact: Boehringer Ingelheimemail@example.com|
|Responsible Party:||Boehringer Ingelheim|
|Other Study ID Numbers:||
2020-000384-23 ( EudraCT Number )
|First Posted:||January 28, 2022 Key Record Dates|
|Last Update Posted:||March 21, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|Time Frame:||After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.|
|Access Criteria:||For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Glomerulosclerosis, Focal Segmental
Renal Insufficiency, Chronic