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

Phase 1

• Conditions: Chronic kidney diseaseProteinuria; MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.1Level: PTClassification code 10037032Term: ProteinuriaSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2021-002071-19-PL
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-31
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

1. Participants must be 6 months to <18 years old at the time when the informed consent/assent is signed
2. 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
3. Participants must have stable kidney function between screening and D0 defined as:
a. no increase or decrease in eGFR = 15% for children =1 year or
b. no increase or decrease in creatinine = 0.10 mg/dL for children <1 year
4. 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
5. 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
6. participants may be recruited at outpatient clinics and hospitals
7 Participants in the study must have a body weight =4.0 kg at Visit 1.
8. pregnancy tests must be performed and women must use effective contraception according to their sexual maturity and sexual activity, in accordance with local requirements for female participants in Clinical Trials.
9. The participant is of the legal age to give informed consent to participate in the study: The participant is able to give written informed consent in accordance with Section 10.1.3 of the study protocol; informed consent includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
Participants unable by law to give informed consent to participate in the study: The participant understands the objectives of the study and signs the consent form for inclusion in the study, if necessary. Parent(s) or legal guardian(s) are able to give informed consent in writing in accordance with Section 10.1.3 of the study protocol.
(10) The participant is able to take food (e.g., solid food, milk from a bottle, through a nasogastric probe [NG] or gastric tube). The participant may also be breastfed.
(11) The parent(s)/e or legal guardian must be available to allow the study center staff to monitor and observe the participant, must come with the participant to the study center according to the visit schedule (i.e., for scheduled visits, procedures and treatments according to the treatment plan, laboratory tests, and other study procedures), must be able to provide information about the participant at any time, and must accurately measure doses of study drug according to instructions received.
12 The participant's parent(s) or legal guardian must be able to reliably document the child's condition at home, including the child's overall health.
Are the trial subjects under 18? yes
Number of subjects for this age range: 219
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Planned urological surgery expected to influence renal function
2. Children with hemolytic uremic syndrome diagnosed =6 months prior to screening
3. Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening
4. Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame. Scheduled renal transplant within the next 6 months
5. Renal allograft in place
6. Bilateral renal artery stenosis
7. Acute kidney injury requiring dialysis within 6 months prior to screening
8. Patients with genetically defined primary tubulopathies leading to tubular proteinuria, such as Dent´s disease
9. Stage 2 hypertension in children =1 year of age, defined according to blood pressure control guidelines (see Tables 10.2 and 10.3 with guidelines in Appendix 10.2) at screening or randomization.
10. SBP above 110 mmHg in infants 6 months to <1 year of age at screening or randomization
11. 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 (lowdose
glucocorticoids or a short course of glucocorticoids for, e.g., treatment of an asthma exacerbation are allowed)
12. Known hypersensitivity to the study treatment (active substance or excipients)
13. Addison’s disease
14. Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores
15. Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids, within <6 months prior to screening for any reason
16. Concomitant treatment with an MRA (eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any SGLT2 inhibitor (SGLT2i), a sacubitril/valsartan combination (ARNI), or a potassium-sparing diuretic (amiloride, triamterene), within 30 days before the screening visit.
17. Concomitant therapy with both ACEI and ARBs in case one of those cannot be discontinued at least 30 days prior to the screening visit
18. Concomitant treatment with strong CYP3A4 inhibitors or moderate or strong CYP3A4 inducers within 7 days prior to randomization (a list of the most common drugs considered strong CYP3A4 inhibitors or moderate or strong CYP3A4 inducers will be provided separately).
19. Previous assignment to treatment during this study
20. Simultaneous participation in another interventional clinical study (e.g., Phase 1-3 clinical studies) or treatment with any investigational medicinal product within 30 days prior to Run-in visit
21. Any other condition or therapy, which would make the participant unsuitable for this study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 6 months)
22. Any other history, condition, therapy, or uncontrolled intercurrent illness which could in the opinion of the investigator affect compliance with study requirements
23. Pregnant or breast-feeding or intention to become pregnant during the study
24. Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified