Overview
Sponsor-declared trial summary
Dialysis Heart failure
To study the clinical response to furosemide administered intraperitoneally compared to orally on the hydration status of stable patients in a PD unit.
Key facts
- Sponsor
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 13 Jun 2025 → ongoing
- Decision date (initial)
- 2025-03-04
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Hospital Univeristario Doctor Peset
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Dose response, Safety, Pharmacokinetic
To study the clinical response to furosemide administered intraperitoneally compared to orally on the hydration status of stable patients in a PD unit.
Secondary objectives 1
- To confirm intraperitoneal absorption of furosemide by determining serum and intraperitoneal levels.
Conditions and MedDRA coding
Dialysis Heart failure
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Patients on treatment with a daily dose equal to or higher than 120 mg of stable oral furosemide during previous fifteen days .
- Patients over 18 years of age
- Clinically stable patients in PD technique
- Patients with a normofunctioning PD catheter
- Patients with residual diuresis greater than 500ml per day
- Patients who have undergone a peritoneal equilibrium test in the previous three months
- Patients who wish to participate and who sign the informed consent form
Exclusion criteria 3
- Allergy to furosemide
- Inability of the patient or caregiver to administer intraperitoneal therapy at home
- Need to modify the rest of the oral diuretic treatment at the time of inclusion in the study and during follow-up
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 8
- efficiency and safety measures
- reduction in body fluid volume
- weight
- blood preasure
- presence of oedema
- bioimpedance values
- ultrasound values (venous excess ultrasound score, VEXUS, and lung ultrasound)
- biochemical markers of congestion: CA125 and NT-proBNP
Secondary endpoints 2
- other measures of interest
- Increased diuresis: 24-hour urine volume, 24-hour urine sodium
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB02287MIG · Substance
- Active substance
- Furosemide Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAPERITONEAL USE
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 30 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
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Sponsor organisation
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Address
- Avenida Cataluna 21
- City
- Valencia
- Postcode
- 46020
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Contact name
- Sandra Beltrán Catalán
Public contact point
- Organisation
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Contact name
- Sandra Beltrán Catalán
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruiting | 37 | 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 |
|---|---|---|---|---|---|
| Spain | 2025-06-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PROTOCOLO_2024-519356-87 | 1 |
| Recruitment arrangements (for publication) | K1_PROCEDIMIENTOS DE RECLUTAMIENTO_2024-519356-87 | 1 |
| Subject information and informed consent form (for publication) | L1_HIP-CI_general_2024-519356-87 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_SEGURIL | 1 |
| Synopsis of the protocol (for publication) | D1_SINOPSIS PROTOCOLO_2024-519356-87 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-10 | Spain | Acceptable 2025-03-03
|
2025-03-04 |