BridgeMD
A study to learn how well finerenone works; how safe it is; how it moves into, through, and out of the body; and the effects it has on the body when taken by children with chronic kidney disease and proteinuria in addition to angiotensin-converting enzyme inhibitor or angiotensin receptor blocker
EU CTIS ID: 2023-504884-17-00
What this study is testing
The primary objective is to demonstrate that finerenone in addition to an ACEI or ARB is superior to placebo in reducing urine protein excretion
- Therapeutic confirmatory (Phase III)
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
- Participants must be 6 months to <18 years old at the time when the informed consent/assent is signed
- Participants must have a clinical diagnosis of chronic kidney disease (CKD) at screening which is defined as a. CKD stages 1-3 (eGFR ≥30 mL/min/1.73m^2) for children ≥1 year to <18 years of age or b. a serum creatinine ≤ 0.40 mg/dL for infants 6 months to < 1 year of age and c. severely increased proteinuria as defined by i. Urinary protein-to-creatinine ratio (UPCR) of ≥ 0.50 g/g in participants ≥ 2 years with CKD stage 2 and 3 or ii. UPCR ≥ 1.0 g/g for patients < 2 years of age or ≥ 2 years of age and with CKD stage 1
- Participants must have stable kidney function between screening and D0 defined as: a. For participants with a creatinine of > 0.8 mg/dL at screening: no increase or decrease in eGFR by ≥ 20% at D0 b. For participants with a creatinine of ≤ 0.8 mg/dL at screening: no increase or decrease in creatinine ≥ 0.15 mg/dL at D0.
- Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure management, unchanged for at least 30 days prior to screening
- K+ ≤5.0 mmol/L for children ≥2 years of age at both screening and D0, and ≤5.3 mmol/L for children <2 years of age at both screening and D0
You likely can't join if
- Planned urological surgery expected to influence renal function
- Systemic hypotension defined as a systolic blood pressure below the 5th percentile for age, sex and height at either screening or randomization but no lower than 80 mmHg (although for some participants the 5th percentile of SBP is < 80 mmHg they must be excluded if their SBP is <80 mmHg)
- Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or high-dose glucocorticoids (e.g., prednisolone ≥0.5 mg/kg/d), within <6 months prior to screening (low-dose glucocorticoids or a short course of glucocorticoids for, e.g., treatment of an asthma exacerbation are allowed)
- Children with hemolytic uremic syndrome (HUS) diagnosed ≤6 months prior to screening
- Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening
- Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
See the full eligibility criteria
Who can join
- Participants must be 6 months to <18 years old at the time when the informed consent/assent is signed
- Participants must have a clinical diagnosis of chronic kidney disease (CKD) at screening which is defined as a. CKD stages 1-3 (eGFR ≥30 mL/min/1.73m^2) for children ≥1 year to <18 years of age or b. a serum creatinine ≤ 0.40 mg/dL for infants 6 months to < 1 year of age and c. severely increased proteinuria as defined by i. Urinary protein-to-creatinine ratio (UPCR) of ≥ 0.50 g/g in participants ≥ 2 years with CKD stage 2 and 3 or ii. UPCR ≥ 1.0 g/g for patients < 2 years of age or ≥ 2 years of age and with CKD stage 1
- Participants must have stable kidney function between screening and D0 defined as: a. For participants with a creatinine of > 0.8 mg/dL at screening: no increase or decrease in eGFR by ≥ 20% at D0 b. For participants with a creatinine of ≤ 0.8 mg/dL at screening: no increase or decrease in creatinine ≥ 0.15 mg/dL at D0.
- Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure management, unchanged for at least 30 days prior to screening
- K+ ≤5.0 mmol/L for children ≥2 years of age at both screening and D0, and ≤5.3 mmol/L for children <2 years of age at both screening and D0
What rules you out
- Planned urological surgery expected to influence renal function
- Systemic hypotension defined as a systolic blood pressure below the 5th percentile for age, sex and height at either screening or randomization but no lower than 80 mmHg (although for some participants the 5th percentile of SBP is < 80 mmHg they must be excluded if their SBP is <80 mmHg)
- Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or high-dose glucocorticoids (e.g., prednisolone ≥0.5 mg/kg/d), within <6 months prior to screening (low-dose glucocorticoids or a short course of glucocorticoids for, e.g., treatment of an asthma exacerbation are allowed)
- Children with hemolytic uremic syndrome (HUS) diagnosed ≤6 months prior to screening
- Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening
- Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
- Renal allograft in place
- Bilateral renal artery stenosis
- Acute kidney injury requiring dialysis within 6 months prior to screening
- Systemic hypertension stage 2 in children ≥1 year of age defined according to guidelines on blood pressure management at screening or randomization
- Systolic blood pressure (SBP) above 110 mmHg in infants 6 months to <1 year of age at screening or randomization
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- South Africa
- United Kingdom
- Korea, Republic of
- India
- Mexico
- Australia
- Brazil
- Switzerland
- Turkey
- United States
- Canada
- Malaysia
- Argentina
- Israel
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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; South Africa; United Kingdom; Korea, Republic of; India; Mexico and 9 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.