A study to evaluate the effects of BI 764198 in adults and adolescents with focal segmental glomerulosclerosis (FSGS)

3 1

What is this study about?

This study investigates the effects of a medication called BI 764198 in people with Focal Segmental Glomerulosclerosis, which is a rare kidney disease that damages the small filtering units in the kidneys. The study specifically looks at individuals with primary focal segmental glomerulosclerosis or those with a version of the disease caused by TRPC6 gene mutations, which are changes in the genetic code that affect how the disease behaves. Some participants may also be taking a calcineurin inhibitor, which is a type of medicine used to manage certain immune-related conditions.

The purpose of the study is to determine if BI 764198 is more effective than a placebo at reducing the amount of protein leaked into the urine. During the study, participants will take either the active medication or a placebo in the form of an oral film-coated tablet. The treatment period lasts for 104 weeks, and the process is double-blind, meaning neither the participants nor the researchers know which treatment is being administered during the trial.

Who Can Join the Study?

  • You must be a male or female aged 12 years or older on the day you sign the consent forms.
  • Your weight must be at least 40 kg (about 88 pounds).
  • Your Body Mass Index (BMI), which is a measure of body fat based on your height and weight, must be 40 or less.
  • You must have a confirmed diagnosis of focal segmental glomerulosclerosis (FSGS), which is a rare kidney disease, through either:
    • A biopsy (a procedure where a small piece of kidney tissue is removed to be examined under a microscope).
    • A genetic test showing a specific change, called a gain-of-function mutation, in the TRPC6 gene.
  • Your urinary protein-to-creatinine ratio (UPCR), which is a test that measures the amount of protein in your urine compared to a waste product called creatinine, must be 1500 mg/g or higher.
  • Your estimated glomerular filtration rate (eGFR), which is a calculation used to measure how well your kidneys are filtering waste from your blood, must be 25 mL/min/1.73 m2 or higher.

Who Cannot Join the Study?

  • You have a known genetic condition or a syndrome that causes focal segmental glomerulosclerosis (a type of kidney disease), unless it is specifically caused by a TRPC6 gain-of-function mutation (a specific type of change in a gene that makes it more active than normal).
  • There is evidence from a doctor or a histologic examination (a study of tissue samples under a microscope) that your kidney disease was caused by other factors, such as damage from toxins or other medical conditions.
  • Your kidney disease is classified as FSGS-UC, which means the cause of the disease is currently unknown, and this was diagnosed before your first visit to the study.
  • You have a history of receiving an organ transplant (an operation where a healthy organ is placed into your body to replace a damaged one) or if you are planning to have an organ transplant while participating in this study.
  • You have used intravenous immunosuppressive agents (medicines given directly into a vein to lower the body’s immune system response) such as cyclophosphamide, rituximab, or obinutuzumab within the last 6 months before your first study visit.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy Warsaw Poland

Verified Sites

Other Sites

Site Name City Country Status
Hospital Del Mar Barcelona Spain
Fundeni Clinical Institute Bucharest Romania
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Danderyds Sjukhus AB Danderyd Sweden
Unidade Local De Saude De Loures-Odivelas EPE Loures Portugal
Azorg Aalst Belgium
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari Bari Italy
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie Warsaw Poland
Karolinska University Hospital Solna Sweden
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Usjfrdissknagcbffydok Nefxoregdi Hk Tromsø Norway
Uvxfkbprhra nlyrjuwql Lf Pvvzkmkn Kcynqa Kosice Slovakia
Hcwxkuve Vobl dfhaelja Barcelona Spain
Ujmzwpiuwh Hqmpawbk Chexpqy Cologne Germany
Acibkqsti Uka Amsterdam The Netherlands
Rvdfep Semsm Smtkos Uxdlkaqllcpzqofqkwz Lund Sweden
Aenwlonq Uxiicgydcu Hypgsrun Lorenskog Norway
Hiiaitjr Cqweni Dz Bfffywuju Barcelona Spain
Cfkmtd Hrkyzmrrxp E Ubihhwzqizhzy Dm Cninkbi Edibka Coimbra Portugal
Hzeraoqv Cbltulm Sqq Cjkexv Madrid Spain
Cdcz Dp Nilxs Vandoeuvre Les Nancy France
Glsnecm Uhgfyiuupp Hohqclpg Ov Pqcrtz Patras Greece
Umsbjnssiajirhdmssyjw Hmwiecztdz Avv Heidelberg Germany
Ufphvcmiaqpg Lfpixcr Leipzig Germany
Rcjqkhkuekbovz Copenhagen Denmark
Axwdlcm Urznc Scoluzgia Lqspkl Da Byvgral Bologna Italy
Upfukkuoch Meputrg Cdndks Hrbsuvfawzmorzhse Hamburg Germany
Cnwuvc Hiwnybfodav Uvwvuwyukdxov Dq Nzicg Nimes France
Cjgjar hhaynsmdsnv useoeknhrhlec dw Lnsyo Liege Belgium
Uxgixupneltg Meujvib Cksvkwd Gxlntgzpf Groningen The Netherlands
Htvgdgwv Sjba Jlcn Dl Dfw Bxhnsjmdd Esplugues De Llobregat Spain
Hlmxjfgx Uadfromffgqbt 1r Di Opxrhds Madrid Spain
Hotix Srpjmdnqg Hg Stavanger Norway
Ulqcvhhfpxp Nkifosdsy Mpkpka Martin Slovakia
Cttq Cpzapv Cfolsmn Alnbtqugy Bgdsi Afapolbibe Braga Portugal
Uymvaebbzu Gvatogu Hfksutfp Ob Htjzesvod Heraklion Greece
Hhrtspvs Uaiwpuxbcrjiv Vxkryu Di Lje Nsthhp Granada Spain
Aqrgkfs Sgxdh Siuxwzxcp Twpxjufnxuve Dab Szblq Lnsqf Varese Italy
Ubpcvmvnglvwp Sbcdmow Ksofbzhtc Ni 2 Pvi W Sdfyirhydl Szczecin Poland
Awfyfls Setfhqivasraxz Tpzhtznlopgz Sinxv Prawp E Cqgld Milan Italy
Chzndb Hudwglhlvs di Snclchi Ekeuso Setubal Portugal
Rvgdjy Owmmcwkcrctfmo Linkoping Sweden
Uyvctxjsye Hotqpdih Sjfxk Dql Zagreb Croatia
Afbjdcw Odjfiwvyotl Unjmtixzkifjm Pbyhugpdbxz Powlo Gqcuoegt Palermo Italy
Unmvsdh Luhgt Dp Swpqc Ds Aewxwxh Slxbsp Egaefu Amadora Portugal
Hxltwksw Udnnrfbjcacau Tsreezqpalbqc Almeria Spain
Unkmpuxwpn Hxkjtuiy Bwlrkmdsga Bratislava Slovakia
Rpokvh Szeskxmry Holbæk Denmark
Uekdzaw Uomwixewzx Hrpsfdxd Uppsala Sweden
Utychuvyeeirhqymlcnpd Wnvkiecmj Air Wuerzburg Germany
Ckqjhg Hcplunhjanp Ufvawntglzhpp Acdkgn Pokjwodc Amiens France
Crlkyu Hwycrabela Uxtvxowbmqdyl Dy Sxdfj Acsdvpr Eizuak Porto Portugal
Vmtuizmf Nlqcdrov fljg Gbsmodmpwj Gaeb Berlin Germany
Cjgkcf Hxufwstfdhp Lden Szg Pierre Benite France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
05.12.2025
Croatia Croatia
Recruiting
05.12.2025
Denmark Denmark
Recruiting
05.12.2025
France France
Recruiting
05.12.2025
Germany Germany
Recruiting
05.12.2025
Greece Greece
Recruiting
05.12.2025
Italy Italy
Recruiting
05.12.2025
Norway Norway
Recruiting
05.12.2025
Poland Poland
Recruiting
05.12.2025
Portugal Portugal
Recruiting
05.12.2025
Romania Romania
Recruiting
05.12.2025
Slovakia Slovakia
Recruiting
05.12.2025
Spain Spain
Recruiting
05.12.2025
Sweden Sweden
Recruiting
05.12.2025
The Netherlands The Netherlands
Recruiting
05.12.2025

Trial locations

BI 764198 is an experimental medicine taken by mouth that works by inhibiting a specific protein in the body called TRPC6. This treatment is being studied to see if it can help reduce the amount of protein lost in the urine for people with certain types of kidney diseases known as focal segmental glomerulosclerosis.

Focal segmental glomerulosclerosis – This condition affects the small filtering units of the kidneys known as glomeruli. It is characterized by scarring in certain parts of these filters. As the disease progresses, the damage to the kidney structures can lead to increased amounts of protein being released into the urine. This process often results from damage to the specialized cells that help filter blood. Over time, the scarring can spread and affect the overall ability of the kidneys to function properly.

Trial ID:
2025-522191-86-00
Protocol code:
1434-0017
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of Atacicept Treatment for Patients with Multiple Autoimmune Glomerular Diseases

    Recruiting

    2 1 1
    Investigated Drugs:
    Belgium France Germany Italy Poland Spain
  • Study on Frexalimab, SAR442970, and Rilzabrutinib for Patients Aged 16-75 with Focal Segmental Glomerulosclerosis or Minimal Change Disease

    Recruiting

    2 1
    Czechia France Germany Greece Hungary Italy +5