BridgeMD
PODOMOUNT-Basket, a study to test whether BI 764198 helps adults and adolescents with different types of kidney disease
EU CTIS ID: 2025-523425-17-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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. Body Mass Index (BMI) of ≤40 kg/m2 at screening visit (Visit 1)
- 3. Weight of ≥40 kg at screening
- 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. 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. 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
You likely can't join if
- 1. A history of organ transplantation or planned transplantation during the course of the study
- 2. Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)
- 3. Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial
- 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. 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. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >3X the upper limit of normal (ULN) at screening visit (Visit 1)
See the full eligibility criteria
Who can join
- 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. Body Mass Index (BMI) of ≤40 kg/m2 at screening visit (Visit 1)
- 3. Weight of ≥40 kg at screening
- 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. 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. 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. 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. 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
- Further inclusion criteria apply.
What rules you out
- 1. A history of organ transplantation or planned transplantation during the course of the study
- 2. Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)
- 3. Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial
- 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. 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. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >3X the upper limit of normal (ULN) at screening visit (Visit 1)
- 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. 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.
The study team makes the final eligibility decision.
Where it's taking place
- China
- United States
- Hong Kong
- New Zealand
- Australia
- United Kingdom
- Malaysia
- India
- Turkey
- Canada
- Brazil
- Taiwan
- Korea, Republic of
- Switzerland
- Japan
- Mexico
- Singapore
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; United States; Hong Kong; New Zealand; Australia; United Kingdom and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.