Overview
Sponsor-declared trial summary
Risk factors of cardiovascular disease
To study the effects of roxadustat on glucose and lipid metabolism and cardiovascular function
Key facts
- Sponsor
- Pohjois-Pohjanmaan hyvinvointialue
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 7 Aug 2024 → ongoing
- Decision date (initial)
- 2024-04-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Oulun yliopistollinen sairaala · University of Oulu
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To study the effects of roxadustat on glucose and lipid metabolism and cardiovascular function
Conditions and MedDRA coding
Risk factors of cardiovascular disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Body mass index over 20 kg/m2 and body weight below 100 kg
- Good general health based upon the results of the medical history, laboratory tests, physical examination, and 12-lead ECG as assessed by the investigator
Exclusion criteria 15
- Regular medication (not including hormonal intrauterine device)
- Previous venous thrombosis or previous convulsions
- Family history of significant venous thrombosis
- Familial galactose intolerance, total lactase deficiency or absorbtion deficiency of glucose and galactose
- Allergy to peanut or soy
- Unable to speak Finnish
- Significant surgery 6 months before trial
- Participation in another clinical trial one month before beginning of the trial
- Abuse of alcohol or medicines or use of drugs
- Fear of pricking and previous difficult blood sampling
- Significant diseases
- Systolic blood pressure over 150 mmHg
- Hemoglobin levels above Finnish reference values
- Pregnancy or breast feeding
- WOCBP not using very potent contraception during study periods and one week after
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Plasma total cholesterol levels
Secondary endpoints 5
- Plasma LDL cholesterol and triglyceride levels
- Insulin resistance and glucose tolerance
- Body composition
- Blood pressure
- Skeletal muscle microcirculation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Evrenzo 70 mg film-coated tablets
PRD10503015 · Product
- Active substance
- Roxadustat
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 8 Day(s)
- Authorisation status
- Authorised
- ATC code
- B03XA05 — -
- Marketing authorisation
- EU/1/21/1574/008
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
SUB21402 · Substance
- Active substance
- Placebo
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 8 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pohjois-Pohjanmaan hyvinvointialue
- Sponsor organisation
- Pohjois-Pohjanmaan hyvinvointialue
- Address
- Kajaanintie 50
- City
- Oulu
- Postcode
- 90220
- Country
- Finland
Scientific contact point
- Organisation
- Pohjois-Pohjanmaan hyvinvointialue
- Contact name
- Janne Hukkanen
Public contact point
- Organisation
- Pohjois-Pohjanmaan hyvinvointialue
- Contact name
- Janne Hukkanen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 24 | 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 |
|---|---|---|---|---|---|
| Finland | 2024-08-07 | 2024-10-04 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-19 | Finland | Acceptable 2024-04-11
|
2024-04-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-14 | Finland | Acceptable 2024-04-11
|
2024-04-14 |