Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
75
Countries
1
Sites
1
type 2 diabetes mellitus
The main goal is to demonstrate the effect of finerenone on the oxidative stress of renal vasculature.
Key facts
- Sponsor
- Universitaetsklinikum Erlangen AöR
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 18 Jan 2024 → 25 Nov 2025
- Decision date (initial)
- 2023-12-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The main goal is to demonstrate the effect of finerenone on the oxidative stress of renal vasculature.
Conditions and MedDRA coding
type 2 diabetes mellitus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10045242 | Type II diabetes mellitus | 10027433 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- age of 18 - 75 years
- diagnosis of type 2 diabetes mellitus (defined by ADA criteria)
- male and female patients (females of childbearing potential must be using effective contraceptive precautions per CTFG quidance)
- females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit
- informed consent must be given in written form
Exclusion criteria 11
- any other form of diabetes mellitus than type 2 diabetes mellitus
- use of GLP-1 analogue for weight loss or insulin within the past 3 months
- HbA1c ≥ 10.5%
- serum potassium > 4.8 mmol/l
- body mass index > 40 kg/m²
- estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m² (CKD-EPI Formula)
- uncontrolled arterial hypertension (BP ≥ 180/110 mmHg)
- subclinical or clinical hyperthyroidism
- use of strong CYP3A4-Inhibitors (for example Itraconazol, Clarithromycin, Ketoconazol, Ritonavir, Nelfinavir, Cobicistat, Telithromycin, Nefazodon) or CYP3A4-Inducers (for example Rifampicin, Carbamazepin, Phenytoin, Phenobarbital, St. John’s wort (Johanniskraut), Efavirenz)
- use of other aldosterone receptor antagonist like spironolactone or eplerenone or potassium sparing diuretics or direct renin inhibitors
- congestive heart failure (CHF) NYHA stage IV
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Primary endpoint is to analyse the impact of finerenone on the oxidative stress level of renal vasculature by the increase of renal perfusion following vitamin C infusion compared to placebo
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Kerendia 20 mg film-coated tablets
PRD9506430 · Product
- Active substance
- Finerenone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 1.4 g gram(s)
- Max treatment duration
- 10 Week(s)
- Authorisation status
- Authorised
- ATC code
- C03DA05 — -
- Marketing authorisation
- EU/1/21/1616/006
- MA holder
- BAYER AG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kerendia 10 mg film coated tablets
PRD9506151 · Product
- Active substance
- Finerenone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 140 mg milligram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- C03DA05 — -
- Marketing authorisation
- EU/1/21/1616/001
- MA holder
- BAYER AG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Placebo: film-coated tablet without active substance for oral use
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 4
Centricor® Vitamin C Ampullen 100 mg/ml Injektionslösung
PRD1165503 · Product
- Active substance
- Ascorbic Acid
- Substance synonyms
- VITAMIN C, ASCORBIC ACID (E 300), CEVITAMIC ACID, (2R)-2-[(1S)-1,2-DIHYDROXYETHYL]-4,5-DIHYDROXY-FURAN-3-ONE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 6000 mg/h milligram(s)/hour
- Max total dose
- 6000 mg/h milligram(s)/hour
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- A11GA01 — ASCORBIC ACID (VIT C)
- Marketing authorisation
- 6425372.01.01
- MA holder
- WÖRWAG PHARMA GMBH & CO. KG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ACCUPAQUE™ 350 Injektionslösung oder Lösung zum Einnehmen
PRD2886065 · Product
- Active substance
- Iohexol
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- INFUSION
- Max daily dose
- 323 mg/h milligram(s)/hour
- Max total dose
- 323 mg/h milligram(s)/hour
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08AB02 — IOHEXOL
- Marketing authorisation
- 3004003.00.00
- MA holder
- GE HEALTHCARE BUCHLER GMBH & CO. KG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB22706 · Substance
- Active substance
- L-Arginine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 200 mg/kg/h milligram(s)/kilogram/hour
- Max total dose
- 200 mg/kg/h milligram(s)/kilogram/hour
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP2100749 · ATC
- Route of administration
- INFUSION
- Max daily dose
- 3 mg/Kg milligram(s)/kilogram
- Max total dose
- 3 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- V04CH30 — AMINOHIPPURIC ACID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Erlangen AöR
- Sponsor organisation
- Universitaetsklinikum Erlangen AöR
- Address
- Maximiliansplatz 2, Innenstadt Innenstadt
- City
- Erlangen
- Postcode
- 91054
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Erlangen AöR
- Contact name
- Dr. med. Dennis Kannenkeril
Public contact point
- Organisation
- Universitaetsklinikum Erlangen AöR
- Contact name
- Dr. med. Dennis Kannenkeril
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 75 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2024-01-18 | 2025-11-25 | 2024-02-20 | 2025-07-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_FINE | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment_IC_procedure | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment_material_advertisement | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_material_flyer_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_FINE_adult_redacted | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Kerendia_10mg-20mg_Filmtabletten | NA |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_DE_2023-508266-15_redacted | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-09 | Germany | Acceptable 2023-12-13
|
2023-12-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-31 | Germany | Acceptable 2024-08-15
|
2024-08-16 |