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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000384-23 | EudraCT Number | ||
| U1111-1292-1333 | Registry Identifier | UTN, WHO registry |
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This study is open to adults with a type of kidney disease called 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 764198 20 mg | Experimental | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 20 milligrams (mg) of BI 764198 orally for 12 weeks. |
|
| BI 764198 40 mg | Experimental | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 40 milligrams (mg) of BI 764198 orally for 12 weeks. |
|
| BI 764198 80 mg | Experimental | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks. |
|
| Placebo | Placebo Comparator | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 764198 | Drug | One single capsule of 20 milligrams (mg), 40 mg, or 80 mg of BI 764198 orally, once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of at Least 25% Reduction in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Baseline at Week 12 | Predicted probability of patients as a percentage - predicted percentage of patients - achieving at least 25% reduction in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at Week 12 (responders) is reported. Baseline was the average of two 24-hour urine samples collected before Visit 2 (Week 0). Patients who either missed their Week 12, 24-hour UPCR assessment or their Week 12, 24-hour UPCR assessment, occurred later than 5 days after the last dose (Residual Effect Period), were considered as non-responders. The predicted probability of response was calculated using a logistic regression utilizing corticosteroid use at randomization and baseline 24-hr UPCR as covariates and is presented as a percentage. | At baseline and Week 12. |
| Relative Change From Baseline at Week 12 of 24-hour Urine Protein Creatinine Ratio (UPCR) | Relative change from baseline at Week 12 in 24-hour urine protein creatinine ratio (UPCR), is reported. Baseline was the average of two 24-hour urine samples collected before Visit 2 (Week 0). An analysis of covariance (ANCOVA) model was used to estimate the relative change in UPCR from baseline to Week 12 with corticosteroid use at randomization and baseline 24-hr UPCR as covariates. | At baseline and at Week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Visit 3 at Week 12 | Median change in 24-hour urine protein creatinine ratio (UPCR) relative to Visit 3 (Week 1) at Week 12, is calculated by subtracting the 24-hour UPCR, [Week 12] - [Week 1] values per patient, then by calculating the median of these changes, per treatment group. | At Week 1 and Week 12. |
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Inclusion criteria:
Further inclusion criteria apply.
Exclusion criteria:
Further exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrology Consultants, LLC | Huntsville | Alabama | 35805 | United States | ||
| University of California San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41616795 | Derived | Trachtman H, Kretzler M, Gesualdo L, Cross N, Workeneh B, Kaufeld J, Meijers B, Ye Z, Chen Q, Derebail VK, Ng MSY, Ji B, Lobmeyer MT, Retlich S, Licariao Rocha FT, Prasad S, Soleymanlou N. TRPC6 inhibition for the treatment of focal segmental glomerulosclerosis: a randomised, placebo-controlled, phase 2 trial of BI 764198. Lancet. 2026 Feb 7;407(10528):587-598. doi: 10.1016/S0140-6736(25)02255-X. Epub 2026 Jan 27. | |
| 39352759 |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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.
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.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Randomized, double-blind, parallel group trial to assess the efficacy of 3 doses of BI 764198 (20 mg, 40 mg, and 80 mg) compared to placebo in patients with primary focal segmental glomerulosclerosis (FSGS), or patients with monogenic FSGS as a result of TRPC6 mutations.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 764198 20 mg | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 20 milligrams (mg) of BI 764198 orally for 12 weeks. |
| FG001 | BI 764198 40 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2024 | Dec 11, 2025 |
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| Placebo | Drug | One single capsule of placebo matching BI 764198 orally, once a day. |
|
| Change in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Baseline at Week 13 | Median change in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at Week 13, is calculated by subtracting the 24-hour UPCR, [Week 13] - [baseline] values per patient,then by calculating the median of these changes, per treatment group. Baseline was the average of two, 24-hour urine samples collected before Visit 2 (Week 0). | At baseline and at Week 13. |
| Change in 24-hour Urinary Protein Excretion Relative to Baseline at Week 12 | Median change in 24-hour urinary excretion rate relative to baseline at Week 12, is calculated by subtracting the urinary excretion rate, [Week 12] - [baseline], values per patient, then by calculating the median of these changes, per treatment group. Baseline was the average of two, 24-hour urine samples collected before Visit 2 (Week 0). | At baseline and at Week 12. |
| Pre-dose Plasma Concentration of BI 764198 at Steady-state (Cpre,ss ) at Week 4 and Week 12 | Pre-dose Plasma Concentration of BI 764198 at steady-state (Cpre,ss ) at Week 4 and Week 12 is reported. | At 671.917 hours and at 2015.917 hours after first drug administration. |
| San Francisco |
| California |
| 94121 |
| United States |
| Valiance Clinical Research-South Gate-67878 | South Gate | California | 90280-5219 | United States |
| Valiance Clinical Research-Tarzana-68237 | Tarzana | California | 91356 | United States |
| The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Elixia Fort Lauderdale, LLC | Fort Lauderdale | Florida | 33308 | United States |
| South Florida Research Institute | Lauderdale Lakes | Florida | 33313 | United States |
| Total Research Group, LLC | Miami | Florida | 33126 | United States |
| Emory Children's Center | Atlanta | Georgia | 30322 | United States |
| NANI Research, LLC | Oak Brook | Illinois | 60523 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Tech University Health Sciences Center-Amarillo-63885 | Amarillo | Texas | 79106 | United States |
| Dallas Nephrology Associates Medical Clinic | DeSoto | Texas | 75115-2011 | United States |
| Prolato Clinical Research Center-Houston-68087 | Houston | Texas | 77054 | United States |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Griffith Health | Southport | Queensland | 4125 | Australia |
| Sunshine Hospital | AT Albans | Victoria | 3021 | Australia |
| UZ Leuven | Leuven | 3000 | Belgium |
| Fu Yang people's Hospital | Fuyang | 236000 | China |
| Guangdong Provincial People's Hospital | Guangzhou | 510080 | China |
| The First Afiliated Hospital, Sun Yet-sen University | Guangzhou | 510080 | China |
| Zhejiang Province People's Hospital | Hangzhou | 310014 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | 330006 | China |
| The First People's Hospital of Nanning | Nanning | 530000 | China |
| Tongren hospital, Shanghai Jiaotong University School of Medicine | Shanghai | 200051 | China |
| Shanghai Fifth People's Hospital affiliated to Fudan University | Shanghai | 200240 | China |
| HOP Pellegrin | Bordeaux | 33076 | France |
| HOP Bicêtre | Le Kremlin-Bicêtre | 94270 | France |
| HOP Hôtel-Dieu | Nantes | 44093 | France |
| Universitätsklinikum Köln (AöR) | Cologne | 50937 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| A.O. Policlinico Giovanni XXIII di Bari | Bari | 70124 | Italy |
| Policlinico S. Orsola-Malpighi | Bologna | 40138 | Italy |
| Fondazione Salvatore Maugeri | Pavia | 27100 | Italy |
| New Zealand Clinical Research (ChristChurch) | Christchurch | 8011 | New Zealand |
| Dunedin Hospital | Dunedin | 9016 | New Zealand |
| Hospital Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Fundació Puigvert | Barcelona | 08025 | Spain |
| Hospital Universitari Vall D Hebron | Barcelona | 08035 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| St Luke's Hospital | Bradford | BD5 0NA | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Salford Royal | Salford | M6 8HD | United Kingdom |
| Derived |
| Wooden B, Beenken A, Martinelli E, Saida K, Knob AL, Ke J, Pisani I, Jin G, Lane B, Mitrotti A, Colby E, Lim TY, Guglielmi F, Osborne AJ, Ahram DF, Wang C, Armand F, Zanoni F, Bomback AS, Delsante M, Appel GB, Ferrari MRA, Martino J, Sahdeo S, Breckenridge D, Petrovski S, Paul DS, Hall G, Magistroni R, Murtas C, Feriozzi S, Rampino T, Esposito P, Helmuth ME, Sampson MG, Kretzler M, Kiryluk K, Shril S, Gesualdo L, Maggiore U, Fiaccadori E, Gbadegesin R, Santoriello D, D'Agati VD, Saleem MA, Gharavi AG, Hildebrandt F, Pollak MR, Goldstein DB, Sanna-Cherchi S. Natural History and Clinicopathological Associations of TRPC6-Associated Podocytopathy. J Am Soc Nephrol. 2025 Feb 1;36(2):274-289. doi: 10.1681/ASN.0000000501. Epub 2024 Oct 1. |
| 37678257 | Derived | Salemkour Y, Yildiz D, Dionet L, 't Hart DC, Verheijden KAT, Saito R, Mahtal N, Delbet JD, Letavernier E, Rabant M, Karras A, van der Vlag J, Nijenhuis T, Tharaux PL, Lenoir O. Podocyte Injury in Diabetic Kidney Disease in Mouse Models Involves TRPC6-mediated Calpain Activation Impairing Autophagy. J Am Soc Nephrol. 2023 Nov 1;34(11):1823-1842. doi: 10.1681/ASN.0000000000000212. Epub 2023 Sep 6. |
Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 40 milligrams (mg) of BI 764198 orally for 12 weeks. |
| FG002 | BI 764198 80 mg | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks. |
| FG003 | Placebo | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated set: all patients who received at least one dose of trial medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BI 764198 20 mg | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 20 milligrams (mg) of BI 764198 orally for 12 weeks. |
| BG001 | BI 764198 40 mg | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 40 milligrams (mg) of BI 764198 orally for 12 weeks. |
| BG002 | BI 764198 80 mg | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks. |
| BG003 | Placebo | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Urine Protein-Creatinine Ratio (UPCR) from 24-hour Urine | Mean | Standard Deviation | Ratio |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Achievement of at Least 25% Reduction in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Baseline at Week 12 | Predicted probability of patients as a percentage - predicted percentage of patients - achieving at least 25% reduction in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at Week 12 (responders) is reported. Baseline was the average of two 24-hour urine samples collected before Visit 2 (Week 0). Patients who either missed their Week 12, 24-hour UPCR assessment or their Week 12, 24-hour UPCR assessment, occurred later than 5 days after the last dose (Residual Effect Period), were considered as non-responders. The predicted probability of response was calculated using a logistic regression utilizing corticosteroid use at randomization and baseline 24-hr UPCR as covariates and is presented as a percentage. | Full Analysis Set (FAS): all patients who were randomized and treated with evaluable measurements of 24-hr UPCR at baseline and at least one 24-hr UPCR measurement after the first dose. Patients who either missed their Week 12, 24-hour UPCR assessment or their Week 12, 24-hour UPCR assessment, occurred later than 5 days after the last dose (Residual Effect Period), were considered as non-responders and were included in the analysis. | Posted | Number | 95% Confidence Interval | Predicted percentage of patients | At baseline and Week 12. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Relative Change From Baseline at Week 12 of 24-hour Urine Protein Creatinine Ratio (UPCR) | Relative change from baseline at Week 12 in 24-hour urine protein creatinine ratio (UPCR), is reported. Baseline was the average of two 24-hour urine samples collected before Visit 2 (Week 0). An analysis of covariance (ANCOVA) model was used to estimate the relative change in UPCR from baseline to Week 12 with corticosteroid use at randomization and baseline 24-hr UPCR as covariates. | Full Analysis Set (FAS): all patients who were randomized and treated with evaluable measurements of 24-hr UPCR at baseline and at least one 24-hr UPCR measurement after the first dose. Patients who either missed their Week 12, 24-hour UPCR assessment or their Week 12, 24-hour UPCR assessment, occurred later than 5 days after the last dose (Residual Effect Period), were not included in this analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of change in 24-hour UPCR | At baseline and at Week 12. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Visit 3 at Week 12 | Median change in 24-hour urine protein creatinine ratio (UPCR) relative to Visit 3 (Week 1) at Week 12, is calculated by subtracting the 24-hour UPCR, [Week 12] - [Week 1] values per patient, then by calculating the median of these changes, per treatment group. | Full Analysis Set (FAS): all patients who were randomized and treated with evaluable measurements of 24-hr UPCR at baseline and at least one 24-hr UPCR measurement after the first dose. Only patients with both a valid Visit 3 and Week 12, 24-hour UPCR value were included in the analysis. | Posted | Median | Inter-Quartile Range | grams/grams | At Week 1 and Week 12. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Baseline at Week 13 | Median change in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at Week 13, is calculated by subtracting the 24-hour UPCR, [Week 13] - [baseline] values per patient,then by calculating the median of these changes, per treatment group. Baseline was the average of two, 24-hour urine samples collected before Visit 2 (Week 0). | Full Analysis Set (FAS): all patients who were randomized and treated with evaluable measurements of 24-hr UPCR at baseline and at least one 24-hr UPCR measurement after the first dose. Only patients with both a valid baseline and Week 13, 24-hour UPCR value were included in the analysis. | Posted | Median | Inter-Quartile Range | grams/grams | At baseline and at Week 13. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in 24-hour Urinary Protein Excretion Relative to Baseline at Week 12 | Median change in 24-hour urinary excretion rate relative to baseline at Week 12, is calculated by subtracting the urinary excretion rate, [Week 12] - [baseline], values per patient, then by calculating the median of these changes, per treatment group. Baseline was the average of two, 24-hour urine samples collected before Visit 2 (Week 0). | Full Analysis Set (FAS): all patients who were randomized and treated with evaluable measurements of 24-hr UPCR at baseline and at least one 24-hr UPCR measurement after the first dose. Patients, who either missed their Week 12 urinary excretion rate measure or their Week 12 urinary excretion rate measure occurred later than 5 days after the last dose (Residual Effect Period), were not included in this analysis. | Posted | Median | Inter-Quartile Range | grams/day | At baseline and at Week 12. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pre-dose Plasma Concentration of BI 764198 at Steady-state (Cpre,ss ) at Week 4 and Week 12 | Pre-dose Plasma Concentration of BI 764198 at steady-state (Cpre,ss ) at Week 4 and Week 12 is reported. | All patients who received at least one dose of trial medication and who provide at least one pre-dose concentration that was not excluded due to protocol violation relevant to the evaluation of pharmacokinetics (PK) or due to PK non-evaluability. Patients with no available pre-dose concentration were not included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/liter | At 671.917 hours and at 2015.917 hours after first drug administration. |
|
All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks.
Treated set (TS): all patients who received at least one dose of trial medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BI 764198 20 mg | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 20 milligrams (mg) of BI 764198 orally for 12 weeks. | 0 | 18 | 3 | 18 | 14 | 18 |
| EG001 | BI 764198 40 mg | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 40 milligrams (mg) of BI 764198 orally for 12 weeks. | 0 | 15 | 0 | 15 | 10 | 15 |
| EG002 | BI 764198 80 mg | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks. | 0 | 15 | 1 | 15 | 10 | 15 |
| EG003 | Placebo | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks. | 0 | 14 | 1 | 14 | 10 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lenticular opacities | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oral mucosa haematoma | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Crying | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sense of oppression | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tenderness | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Electrocardiogram ST segment abnormal | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Focal segmental glomerulosclerosis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oligomenorrhoea | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pharyngeal swelling | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Capillary fragility | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2024 | Dec 11, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Logistic regression utilizing corticosteroid use at randomization and baseline 24-hr UPCR as covariates.
| Odds Ratio (OR) |
| 1.53 |
| 2-Sided |
| 95 |
| 0.16 |
| 19.48 |
BI 764198 (comparator) vs. Placebo (reference) |
| Other |
| Logistic regression utilizing corticosteroid use at randomization and baseline 24-hr UPCR as covariates. | Odds Ratio (OR) | 5.97 | 2-Sided | 95 | 0.86 | 73.57 | BI 764198 (comparator) vs. Placebo (reference) | Other |
| OG002 | BI 764198 80 mg | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks. |
| OG003 | Placebo | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks. |
|
|
|
Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks.
| OG003 | Placebo | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks. |
|
|
| BI 764198 80 mg |
Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks. |
| OG003 | Placebo | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks. |
|
|
| OG002 | BI 764198 80 mg | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks. |
| OG003 | Placebo | Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of placebo-matching BI 764198 orally for 12 weeks. |
|
|
Patients with primary focal segmental glomerulosclerosis (FSGS) or patients with monogenic FSGS as a result of TRPC6 mutations took daily one single capsule of 80 milligrams (mg) of BI 764198 orally for 12 weeks.
|
|