FIONA: A Study to Learn More About How Well the Study Treatment 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 With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria

• Sponsor: Bayer (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05196035
• Collaborator: (none)
• Enrollment: 219
• Locations: 122
• Arms: 2
• Anticipated Duration (Months): 53.5
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine.

The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can improve kidney function by helping the renin-angiotensin-aldosterone system (RAAS) to work normally. The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can stop the kidneys from working properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system.

The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB.

So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function.

The main purpose of this study is to learn more about whether finerenone added to either ACEI or ARB can help reduce the amount of protein in the participants' urine more than a placebo. A placebo looks like a treatment but does not have any medicine in it. Participants will also continue to receive their other medications.

To see how the treatment work, the doctors will take samples of the participants' urine to measure their protein levels before and during taking treatment and after their last treatment. In addition, blood samples will be taken to monitor kidney function, electrolytes and the amount of finerenone in the blood as well as for other tests.

This study will include children with CKD and proteinuria aged from 6 months up to less than 18 years. The participants will take:

• either finerenone or the placebo, in addition to

• either ACEI or ARB, whichever they take as part of their normal treatment

Two visits are required up to 104 days, to check whether a child can take part in the treatment phase of the study. If participants qualify for the treatment phase, they will then undergo treatment for about 180 days. During this time, they will visit the study site at least 7 times. During these visits, the participants will:

• have their blood pressure, heart rate, temperature, height and weight measured

• have blood and urine samples taken

• have physical examinations

• have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart)

• answer questions about their medication and whether they have any adverse events , or have their parents or guardians answer

• answer questions about how they are feeling, or have their parents or guardians answer

• answer question about how they like the study medication, or have their parents or guardians answer

The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

The doctors will check the participants' health about 30 days after the participants take their last treatment.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease; Proteinuria	Drug: Finerenone (Kerendia, BAY94-8862); Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 219 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A 6-month Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and PK/PD of an age-and Body Weight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children, 6 Months to <18 Years of Age, With Chronic Kidney Disease and Proteinuria
• Actual Study Start Date: Mar 28, 2022
• Anticipated Primary Completion Date: Aug 12, 2026
• Anticipated Study Completion Date: Sep 11, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Finerenone (Kerendia, BAY94-8862) Participants will receive finerenone treatment.	Drug: Finerenone (Kerendia, BAY94-8862); Finerenone in different doses, treatment duration will be 180±7 days
Placebo Comparator: Placebo Participants will receive placebo to finerenone.	Drug: Placebo; Placebo to finerenone, treatment duration will be 180±7 days

Outcome Measures

Primary Outcome Measures

1. Urinary protein-to-creatinine ratio (UPCR) reduction of at least 30% from baseline to day 180±7 [From baseline to day 180±7]

   Proportion of participants at day 180±7 with a >=30% reduction in UPCR compared to baseline.

Secondary Outcome Measures

1. Number participants with treatment emergent adverse events (TEAEs） [From the start of study intervention to last study intervention + 3 days (up to 190 days)]

   Below sub-categories will be considered: Serious Treatment Emergent Adverse Events (TEAEs) TEAEs and serious TEAEs leading to discontinuation of treatment Study drug related TEAEs and serious TEAEs TEAEs categorized by severity (mild, moderate, severe) TEAEs by maximum intensity Number of participants hospitalized with hyperkalemia, Number of participants discontinuing due to hyperkalemia, Number of participants with hospitalization for worsening of renal function Number of participants discontinuing due to worsening of renal function

2. Change in serum potassium levels from baseline to day 180±7 [From baseline to day 180±7]

3. Change in serum creatinine from baseline to day 180±7 [From baseline to day 180±7]

4. Change in eGFR from baseline to day 180±7 [From baseline to day 180±7]

   Estimated glomerular filtration rate (eGFR)

5. Change in systolic blood pressure from baseline to day 180±7 [From baseline to day 180±7]

6. Mean reduction from baseline to day 180±7 in UPCR [From baseline to day 180±7]

   Percent change from baseline to day 180±7 in UPCR will be calculated.

7. Change in UACR from baseline to day 180±7 [From baseline to day 180±7]

   Urinary albumin-to-creatinine ratio (UACR)

8. Pharmacokinetics (PK) finerenone Cmax, md [Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7]

   Maximum observed finerenone concentration in plasma after multiple doses.

9. Pharmacokinetics (PK) finerenone AUCτ,md [Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7]

   Area under the curve for finerenone concentration in plasma after multiple doses.

10. Taste and texture questionnaire of the pediatric formulation [On day 30±3 and day 180±7]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

• CKD stages 1-3 (eGFR ≥30 mL/min/1.73m^2) for children ≥1 year to <18 years of age or

• a serum creatinine ≤ 0.40 mg/dL for infants 6 months to < 1 year of age and

• severely increased proteinuria as defined by

• Urinary protein-to-creatinine ratio (UPCR) of ≥ 0.50 g/g in participants ≥ 2 years with CKD stage 2 and 3 or

• 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:

• no increase or decrease in eGFR ≥ 15% for children ≥1 year or

• no increase or decrease in creatinine ≥ 0.10 mg/dL for children <1 year

• 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

Exclusion Criteria:

• Planned urological surgery expected to influence renal function

• 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

• 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 using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids, within <6 months prior to screening for any reason

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Medicine	Palo Alto	California	United States	94304
2	Boston hildren's Hospital	Boston	Massachusetts	United States	02115
3	Children's Mercy Hospital & Clinics	Kansas City	Missouri	United States	64108-9898
4	Cincinnati Children's Hospital and Medical Center	Cincinnati	Ohio	United States	45229
5	Cleveland Clinic | Pediatric Nephrology	Cleveland	Ohio	United States	14013
6	Nationwide Children's Hospital	Columbus	Ohio	United States	43205-2696
7	Oregon Health and Science Univ | Doernbecher Childrens Hosp	Portland	Oregon	United States	97239
8	Univ of Texas Health Science Center | Nephrology Res Dept	San Antonio	Texas	United States	78207
9	Seattle Children's Hospital	Seattle	Washington	United States	98105
10	The Children's Hospital at Westmead	Westmead	New South Wales	Australia	2145
11	Queensland Children's Hospital	South Brisbane	Queensland	Australia	4101
12	Monash Children's Hospital	Clayton	Victoria	Australia	3168
13	Royal Children's Hospital Melbourne	Parkville	Victoria	Australia	3052
14	Many Locations	Multiple Locations		Australia
15	Kepler Universitätsklinikum Campus IV	Linz	Oberösterreich	Austria	4020
16	Medizinische Univ Graz | Kinder & Jugendheilkunde	Graz	Steiermark	Austria	8036
17	Many Locations	Multiple Locations		Austria
18	Uniklinikum Salzburg - Landeskrankenhaus	Salzburg		Austria	5020
19	AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie	Wien		Austria	1090
20	Huderf / Ukzkf	Bruxelles - Brussel		Belgium	1020
21	CU Saint-Luc/UZ St-Luc	Bruxelles - Brussel		Belgium	1200
22	UZ Gent	Gent		Belgium	9000
23	UZ Leuven Gasthuisberg	Leuven		Belgium	3000
24	Many Locations	Multiple Locations		Belgium
25	Alberta Children's Hospital, University of Calgary	Calgary	Alberta	Canada	T3B 6A8
26	The Hospital for Sick Children (SickKids)	Toronto	Ontario	Canada	M5G 1X8
27	CHU Sainte-Justine	Montreal	Quebec	Canada	H3T 1C5
28	Many Locations	Multiple Locations		Canada
29	Many Locations	Multiple Locations		China
30	Many Locations	Multiple Locations		Czechia
31	Vseobecna fakultni nemocnice v Praze	Praha 2		Czechia	12808
32	Fakultni nemocnice v Motole	Praha 5		Czechia	150 06
33	Rigshospitalet, Dept Pediatrics & Adelescent Med.	Copenhagen		Denmark	2100
34	Many Locations	Multiple Locations		Denmark
35	Odense, HC Andersen	Odense C		Denmark	5000
36	Aarhus Universitetshospital, Skejby	Århus N		Denmark	8200
37	HUS Uusi lastensairaala	Helsinki		Finland	00290
38	Many Locations	Multiple Locations		Finland
39	Pediatric Early Phase Trial Unit, Tampere University Hospita	Tampere		Finland	33521
40	Turun yliopistollinen keskussairaala	Turku		Finland	20520
41	Hôpital Pellegrin - Bordeaux	BORDEAUX cedex		France	33076
42	CHU de Lyon - Hopital Femme Mère Enfant	Bron		France	69677
43	Hôpital Arnaud de Villeneuve - Montpellier	Montpellier		France	34059
44	Many Locations	Multiple Locations		France
45	Hopital Robert Debre	Paris		France	75019
46	CHU STRASBOURG - Hôpital de Hautepierre	Strasbourg		France	67200
47	Hôpital des Enfants	TOULOUSE Cedex 9		France	31059
48	Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg	Germany	69120
49	Universitätsklinikum Erlangen	Erlangen	Bayern	Germany	91054
50	Medizinische Hochschule Hannover (MHH)	Hannover	Niedersachsen	Germany	30625
51	Universitätsklinikum Essen	Essen	Nordrhein-Westfalen	Germany	45147
52	Universitätsklinikum Münster (UKM)	Münster	Nordrhein-Westfalen	Germany	48149
53	Universitätsklinikum Hamburg Eppendorf (UKE)	Hamburg		Germany	20246
54	Many Locations	Multiple Locations		Germany
55	Children's Hospital of Athens P&A Kyriakou	Athens		Greece
56	University General Hospital of Heraklion	Crete		Greece	71500
57	Ioannina University General Hospital	Ioannina		Greece	45500
58	Many Locations	Multiple Locations		Greece
59	Hippokration General Hospital of Thessaloniki	Thessaloniki		Greece
60	Semmelweis University	Budapest		Hungary	1083
61	Debreceni Egyetem Klinikai Kozpont	Debrecen		Hungary	4032
62	Many Locations	Multiple Locations		Hungary
63	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs		Hungary	7623
64	SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont	Szeged		Hungary	6720
65	Soroka University Medical Center	Beer Sheva		Israel	8410101
66	Wilf Children's Hospital Shaare Zedek Medical Center	Jerusalem		Israel	9103102
67	Many Locations	Multiple Locations		Israel
68	Health Corporation of Galilee Medical Center	Nahariya		Israel	2210001
69	Clalit Health Services Schneider Children's Medical Center	Petach Tikva		Israel	4920235
70	Dana-Dwek Children's Hospital	Tel Aviv		Israel	6423906
71	A.O.U. di Bologna Policlinico S.Orsola Malpighi	Bologna	Emilia-Romagna	Italy	40138
72	IRCCS Ospedale Pediatrico Bambino Gesù	Roma	Lazio	Italy	00165
73	IRCCS Istituto Giannina Gaslini	Genova	Liguria	Italy	16147
74	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano	Lombardia	Italy	20122
75	Many Locations	Multiple Locations		Italy
76	Kyungpook National University Hospital	Daegu	Daegu Gwang''yeogsi	Korea, Republic of	41944
77	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggido	Korea, Republic of	13620
78	Pusan National University Yangsan Hospital	Yangsan-si	Gyeongsangnamdo	Korea, Republic of	50612
79	Seoul National University Hospital	Seoul	Seoul Teugbyeolsi	Korea, Republic of	03080
80	Many Locations	Multiple Locations		Korea, Republic of
81	Hospital of LT University of Health Sciences Kaunas Clinics	Kaunas		Lithuania	LT-50161
82	Klaipeda Children's Hospital	Klaipeda		Lithuania	LT-92140
83	Many Locations	Multiple Locations		Lithuania
84	Children's hospital Affiliate of Vilnius University Hospital	Vilnius		Lithuania	LT-08661
85	Universitair Medisch Centrum Groningen	Groningen		Netherlands	9713 GZ
86	Many Locations	Multiple Locations		Netherlands
87	Universitair Medisch Centrum St. Radboud	Nijmegen		Netherlands	6525 GA
88	University Medical Center Utrecht	Utrecht		Netherlands	3584 CX
89	Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa	Bialystok		Poland	15-274
90	Many Locations	Multiple Locations		Poland
91	Dzieciecy Szpital Kliniczny im. Jozefa Brudzinskiego	Warszawa		Poland	02-091
92	Instytut "Pomnik - Centrum Zdrowia Dziecka"	Warszawa		Poland	04-730
93	Centro Clinico Academico - Braga	Braga		Portugal	4710-243
94	CHULN - H. Sta.Maria (Centro de Investigacao Clinica)	Lisboa		Portugal	1649-035
95	Many Locations	Multiple Locations		Portugal
96	Centro Hospitalar Universitario do Porto	Porto		Portugal	4050-651
97	Hospital de Sant Joan de Déu	Esplugues de LLobregat	Barcelona	Spain	08950
98	Ciutat Sanitària i Universitaria de la Vall d'Hebron	Barcelona		Spain	08035
99	H Univ. 12 de Octubre | Unidad Pediátrica Inv y EECC (UPIC)	Madrid		Spain	28041
100	Many Locations	Multiple Locations		Spain
101	Hospital Regional de Málaga	Málaga		Spain	29010
102	H Univ. Virgen Rocío | Unidad Nefrología Pediátrica	Sevilla		Spain	41013
103	Skåne University Hospital	Lund		Sweden	221 85
104	Many Locations	Multiple Locations		Sweden
105	Karolinska University Hospital	Stockholm		Sweden	141 86
106	Uppsala University Hospital	Uppsala		Sweden	751 85
107	Universitäts-Kinderspital UKBB	Basel	Basel-Stadt	Switzerland	4056
108	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud	Switzerland	1011
109	Many Locations	Multiple Locations		Switzerland
110	Hacettepe Universitesi Tip Fakultesi	Ankara		Turkey	06100
111	Baskent Universitesi Tip Fakultesi Hastanesi	Ankara		Turkey	06490
112	Gazi Universitesi Tip Fakultesi	Ankara		Turkey	06560
113	Ankara Sehir Hastanesi	Ankara		Turkey	06800
114	Istanbul Universitesi Cerrahpasa-Cocuk Nefrolojisi B. Dali	Istanbul		Turkey	34098
115	Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi	Istanbul		Turkey	34899
116	Many Locations	Multiple Locations		Turkey
117	Birmingham Children's Hospital	Birmingham	West Midlands	United Kingdom	B4 6NH
118	Royal Hospital for Children	Glasgow		United Kingdom	G51 4TF
119	Great Ormond Street Hospital for Children	London		United Kingdom	WC1N 3JH
120	Royal Manchester Children's Hospital	Manchester		United Kingdom	M13 9WL
121	Many Locations	Multiple Locations		United Kingdom
122	Queens Medical Centre	Nottingham		United Kingdom	NG7 2UH

Sponsors and Collaborators

• Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT05196035
• Other Study ID Numbers: 19920; 2021-002071-19
• First Posted: Jan 19, 2022
• Last Update Posted: Aug 23, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria

Study Results

No Results Posted as of Aug 23, 2022