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Recruiting Phase 2 NCT07355296

PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease

Phase 2 – studying effectiveness and dosage
Conditions: Proteinuric Kidney Diseases

Sponsor: Boehringer Ingelheim

trial.available_in: БГ
Overview
This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions. Participants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group. Participants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Who can participate
Inclusion Criteria: * Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent/assent (Visit 1) * Body Mass Index (BMI) of ≤40 kg/m2 at screening visit (Visit 1) * Weight of ≥40 kg at screening * Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit * For adult participants (≥18); ≥25 mL/min/1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit * For adolescent participants (\<18); ≥25 mL/min/1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening visit * Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants \<18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and "true" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants \<18) * Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator * If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20) * Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil/-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period * Patients treated/to be treated with oral glucocorticoids have to be at a dose ≤10 mg/d prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period. Further inclusion criteria apply. Exclusion Criteria: * A history of organ transplantation or planned transplantation during the course of the study * Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1) * Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial * Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit * Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (CYP3A4/5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2) * Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \>3X the upper limit of normal (ULN) at screening visit (Visit 1) * Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) 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 (Visit 1) Further exclusion criteria apply.
Locations 29
Argentina (1)
Centro Medico Dra Laura Maffei
Ciudad Autonoma Buenos Aires
NOT_YET_RECRUITING
Australia (1)
Nepean Hospital
Kingswood , New South Wales
NOT_YET_RECRUITING
Belgium (1)
AZORG Ziekenhuis
Aalst
NOT_YET_RECRUITING
Brazil (1)
Universidade Federal do Ceará
Fortaleza
NOT_YET_RECRUITING
Canada (1)
CaRe Clinic (Calgary)
Calgary , Alberta
NOT_YET_RECRUITING
China (1)
Peking University First Hospital
Beijing
NOT_YET_RECRUITING
Croatia (1)
Specialty Hospital Medico
Rijeka
NOT_YET_RECRUITING
Denmark (1)
Zealand University Hospita; Roskilde
Roskilde
NOT_YET_RECRUITING
Estonia (1)
Tartu University Hospital
Tartu
NOT_YET_RECRUITING
France (1)
CHU Amiens-Picardie
Amiens
NOT_YET_RECRUITING
Greece (1)
University General Hospital of Heraklion
Heraklion
NOT_YET_RECRUITING
India (1)
Aartham Multi Super Speciality Hospital
Ahmedabad
NOT_YET_RECRUITING
Italy (1)
Azienda Ospedaliero Universitaria delle Marche
Ancona
NOT_YET_RECRUITING
Japan (1)
Kasugai Municipal Hospital
Aichi, Kasugai
NOT_YET_RECRUITING
Malaysia (1)
Hospital Selayang
Batu Caves
NOT_YET_RECRUITING
Netherlands (1)
Amsterdam UMC Locatie AMC
Amsterdam
NOT_YET_RECRUITING
New Zealand (1)
Pacific Clinical Research Network - Auckland
Auckland
NOT_YET_RECRUITING
Norway (1)
Akershus Universitetssykehus HF
Lørenskog
NOT_YET_RECRUITING
Poland (1)
Central Clinical Hospital of the Medical University of Lodz
Lodz
NOT_YET_RECRUITING
Romania (1)
Institutul Clinic Fundeni
Bucharest
NOT_YET_RECRUITING
Singapore (1)
Singapore General Hospital
Singapore
NOT_YET_RECRUITING
Slovakia (1)
F D Roosevelt University General Hospital Of Banska Bystrica
Banská Bystrica
NOT_YET_RECRUITING
South Korea (1)
Kyung Hee University Hospital at Gangdong
Seoul
NOT_YET_RECRUITING
Spain (1)
Hospital Universitari Vall d'Hebron
Barcelona
NOT_YET_RECRUITING
Sweden (1)
Danderyds Sjukhus
Danderyd
NOT_YET_RECRUITING
Taiwan (1)
Taipei Medical University-Shuang Ho Hospital
New Taipei City
Turkey (1)
Adana City Hospital
Adana
NOT_YET_RECRUITING
United Kingdom (1)
Bradford Institute for Health Research
Bradford
NOT_YET_RECRUITING
United States (1)
Nephrology Consultants, LLC
Huntsville , Alabama
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Healthy volunteers
No
Start date
23.03.2026
Completion date
21.01.2028
Registry ID
NCT07355296
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.