The effect of saline with a high koncentration and furosemide on biomarkers of kidney damage togerther with kidney and circulatory physiology in healthy subjects.

The effect of 3% NaCl and furosemid on biomarkers and the kidneys managment of sodium and water, vasoactive hormones and GFR in healthy subjects.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002585-23-DK

Enrollment

Registered

2015-11-05

Start date

2016-01-08

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers (The effect of flurosemide, together with an infusion of hypertone saline, on the kidneys, using biomarkers) MedDRA version: 18.1 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Furix Pharmaceutical Form: Infusion INN or Proposed INN: FUROSEMIDE CAS Number: 54-31-9 Concentration unit: mg/l milligram(s)/litre Concentration type: equal Concentration number: 10- Phar

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Men and Women • age 18-40 • BMI 18,5-30,0 kg/m2 Fertile women most use safe contraceptives through the trail period, defined as intrauterine devices, abstinens and hormonal contraceptives (birth control pills, contraceptives implants, contraceptives injektion, contraceptives patch, vaginal ring). Excepted are postmenopausal women with no menstruation in at least 12 month before inclusion, surgical sterilization or women with sterilized regular partner. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 27 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Tobacco smoking (Non-smokers in more than 3 months can be included) • Medicine- or drug abuse • Alcohol abuse >14 units for women >21 units for men • Medical treatment (over the counter medication will evaluated whether or not it is grounds for exclusion) within 2 weeks before the trail period starts except contraception. • Pregnancy or nursing • Neoplastic disorders • Significant clinical signs of heart-, lung-, liver-, kidney-, endocrine- or brain disorders • Clinically significant abnormal findings in screening blood samples, urine sample or ECG • Office blood pressure over 140/90 mmHg • Donation of blood within 1 month of the first day of investigation. • Allergy against compounds in investigational medicine

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of chloride together with flurosemide on the kidneys in a randomized, single-blind, placebo-controlled, cross-over study in healthy subjects, by measuring biomarkers, kidney function and vasoactive hormones.;Secondary Objective: ;Primary end point(s): Urinary neutrophil gelatinase-associated lipocalin concentration;Timepoint(s) of evaluation of this end point: When all subjects have completed and the blood and urine samples have been analyzed.	—

Measure

Time frame

Main Objective: To investigate the effect of chloride together with flurosemide on the kidneys in a randomized, single-blind, placebo-controlled, cross-over study in healthy subjects, by measuring biomarkers, kidney function and vasoactive hormones.;Secondary Objective: ;Primary end point(s): Urinary neutrophil gelatinase-associated lipocalin concentration;Timepoint(s) of evaluation of this end point: When all subjects have completed and the blood and urine samples have been analyzed.

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Secondary

Measure	Time frame
Secondary end point(s): Biomakers: u-KIM, u-FABP, TIMP, IGFBP7 Vasoactive hormones: PRC, p-Ang-II, p-AVP, p-Aldo Transport channels: u-AQP2, u-EnaC, u-NCC, u-NK2CC Kidney physiology: 51Cr-EDTA-clearance, FENa CH2O, TCO2, p-Cl, u-Cl, Hemodynamic: Puls, central and brachial blood pressure ;Timepoint(s) of evaluation of this end point: When all subjects have completed and the blood and urine samples have been analyzed.	—

Measure

Time frame

Secondary end point(s): Biomakers: u-KIM, u-FABP, TIMP, IGFBP7 Vasoactive hormones: PRC, p-Ang-II, p-AVP, p-Aldo Transport channels: u-AQP2, u-EnaC, u-NCC, u-NK2CC Kidney physiology: 51Cr-EDTA-clearance, FENa CH2O, TCO2, p-Cl, u-Cl, Hemodynamic: Puls, central and brachial blood pressure ;Timepoint(s) of evaluation of this end point: When all subjects have completed and the blood and urine samples have been analyzed.

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Countries

Denmark

Contacts

Public ContactAndreas Nygaard Jørgensen

Medicinsk Forskningsafsnit, Regionshospitalet Holstebro (Department of Medical Research, Regional Hospital Holstebro)

andrjr@rm.dk004578436589

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026