PODOMOUNT-Basket, a study to test whether BI 764198 helps adults and adolescents with different types of kidney disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Decision date (initial)

2026-05-21

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

External identifiers

EU CT number

2025-523425-17-00

WHO UTN

U1111-1328-7108

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Pharmacokinetic, Safety, Efficacy

The primary objective is to estimate the mean relative change from baseline to Week 20 in 24-hr urinary protein-to-creatinine ratio (UPCR, measured in mg/g) in participants in each of the four glomerular disease cohorts (i.e., sFSGS, TR-pMCD, Alport Syndrome, or TR-pMN), some of whom will be on background SGLT2i/CNI treatment.

Secondary objectives 2

1. To compare the response between treatment arms from baseline to Week 20, where response is defined as at least a 25% or 40% within-participant reduction in 24-hr UPCR.
2. To estimate the difference between arms in mean within-participant absolute change in eGFR in ml/min/1.73m2 (based on cystatin C) from baseline to Week 20 in each of the four cohorts.

Conditions and MedDRA coding

Proteinuric kidney diseases

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1. Male or female participants ≥18 years of age (≥12 years of age for TR-pMCD) on the day of signing informed consent/assent (Visit 1)
2. 2. Body Mass Index (BMI) of ≤40 kg/m2 at screening visit (Visit 1)
3. 3. Weight of ≥40 kg at screening
4. 4. Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 (CKD EPI formula based on serum cystatin C) at screening visit (Visit 1) o For adult participants (≥18); ≥25 mL/min/1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit (Visit 1) o For adolescent participants (<18); ≥25 mL/min/1.73 m2 (CKiD U25 formula using height and serum cystatin C) at the screening visit (Visit1)
5. 5. Seated blood pressure (mean of 3 values) 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)
6. 6. 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. EoT, Week 20) unless not tolerated or indicated as per the discretion of the investigator
7. 7. If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or 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)
8. 8. Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. 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
9. Further inclusion criteria apply.

Exclusion criteria 9

1. 1. A history of organ transplantation or planned transplantation during the course of the study
2. 2. Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)
3. 3. Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial
4. 4. Treatment with metformin or dofetilide (MATE1 substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit
5. 5. Treatment with strong inhibitors or strong inducers of CYP3A4/5 within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)
6. 6. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >3X the upper limit of normal (ULN) at screening visit (Visit 1)
7. 7. 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
8. 8. 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)
9. Further exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Relative change from baseline to Week 20 in 24-hr UPCR (mg/g)

Secondary endpoints 3

1. Treatment response, defined as at least 25% relative reduction in 24-hr UPCR from baseline to Week 20
2. Treatment response, defined as at least 40% relative reduction in 24-hr UPCR from baseline to Week 20
3. Absolute change in eGFR in mL/min/1.73m2 (based on cystatin C) from baseline to Week 20

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation

Boehringer Ingelheim International GmbH

Address

Binger Strasse 173

City

Ingelheim Am Rhein

Postcode

55216

Country

Germany

Scientific contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Third parties 2

Boehringer Ingelheim Espana S.A.

Sponsor organisation

Boehringer Ingelheim Espana S.A.

Address

Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles

City

Barcelona

Postcode

08174

Country

Spain

Public contact point

Organisation

Boehringer Ingelheim Espana S.A.

Contact name

CT Disclosure & Data Transparency

Sponsor responsibilities

Article 77 compliance

Boehringer Ingelheim International GmbH

Contact point sponsor

Boehringer Ingelheim International GmbH

Article 77 implementation

Boehringer Ingelheim International GmbH

Locations

16 EU/EEA countries · 54 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 250 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications