Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
52
Countries
1
Sites
1
hyponatremia during subarachnoid hemorrhage
Demonstrate the efficacy of urea therapy in correcting persistent hyponatremia despite adequate management (Appendix 2), during SAH.
Key facts
- Sponsor
- Centre Hospitalier Universitaire Grenoble Alpes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 15 Oct 2020 → 13 Mar 2025
- Decision date (initial)
- 2024-11-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- AOI 2018
External identifiers
- EU CT number
- 2024-518532-36-00
- EudraCT number
- 2020-001084-83
- ClinicalTrials.gov
- NCT04552873
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Demonstrate the efficacy of urea therapy in correcting persistent hyponatremia despite adequate management (Appendix 2), during SAH.
Secondary objectives 7
- Compare the sodium intake required to correct natraemia
- Study the mechanism of action of urea
- Assess the impact of treatment on length of stay
- Evaluate the impact of treatment on neurological outcome at 3 months from inclusion
- Assessing adverse effects of treatment
- Persistence of natraemia correction 48H after discontinuation of treatment
- Comparison of speed of correction of natraemia
Conditions and MedDRA coding
hyponatremia during subarachnoid hemorrhage
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Patients aged 18 and over
- Non-traumatic SAH: Hyponatremia defined by a natraemia of less than 135 mmol/L and a high natriuresis, greater than 250 mmol/J despite well-managed salt intake.
Exclusion criteria 9
- Severe cardiac decompensation (LVEF < 30%)
- Severe hepatic cirrhosis (PT < 30%, ascites), known severe renal insufficiency (GFR < 30mL/min/1.73m²)
- Blood urea > 25 mmol/L in basal state
- Osmotherapy and diuretics in the last 48 hours
- Ongoing treatment with systemic corticosteroids
- Persons covered by articles L1121-5 to L1121-8 of the CSP, corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons not subject to a legal protection measure.
- Patient not affiliated to a social security scheme
- Known hypersensitivity to any component of ergytonyl
- Contraindications to ergytonyl: currently taking curative anticoagulants, previously known and treated diabetic patients
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in natraemia in mmol/L measured before and on day of treatment discontinuation
Secondary endpoints 7
- Compare the sodium intake required to correct natraemia
- Study the mechanism of action of urea
- Évaluer l’impact du traitement sur la durée de séjour
- Évaluer l’impact du traitement sur le devenir neurologique à 3 mois de l’inclusion
- Assessing adverse effects of treatment
- Persistence of natraemia correction 48H after discontinuation of treatment
- Comparison of speed of correction of natraemia
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD8548754 · Product
- Active substance
- Urea Ph. Eur.
- Pharmaceutical form
- ORAL POWDER
- Route of administration
- ORAL
- Max daily dose
- 4800 mg/kg/h milligram(s)/kilogram/hour
- Max total dose
- 24000 mg/kg/h milligram(s)/kilogram/hour
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- Route of administration
- ORAL USE
- Max daily dose
- 5 ml millilitre(s)
- Max total dose
- 25 ml millilitre(s)
- Max treatment duration
- 5 Day(s)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Grenoble Alpes
- Sponsor organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Address
- Boulevard De La Chantourne, Cs 10217, La Tronche Cs 10217 La Tronche
- City
- Grenoble Cedex 9
- Postcode
- 38043
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Contact name
- BOUCHEIX Perrine
Public contact point
- Organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Contact name
- BOUCHEIX Perrine
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 52 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire Grenoble Alpes
Anesthésie-Réanimation, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
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 |
|---|---|---|---|---|---|
| France | 2020-10-15 | 2025-03-13 | 2020-12-03 | 2024-11-26 |
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 signature page_2024-518532-36-00 | 4.0 |
| Protocol (for publication) | D1_Protocol_2024-518532-36-00 | 4.0 |
| Recruitment arrangements (for publication) | Non applicable_2024-518532-36-00 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PATIENT | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_POURSUITE PATIENT | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PROCHE | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-518532-36-00 | 4.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-03 | France | Acceptable 2024-11-27
|
2024-11-29 |