Pharmacokinetic Profile and Pharmacodynamic Characteristics of a Furosemide High Dosage Formulation in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis

Renal Failure Clinical Trial

Official title:

Pharmacokinetic Profile and Pharmacodynamic Characteristics of a Furosemide High Dosage Formulation (PRLasix® Special, Tablets 500 mg) in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724788
• Other study ID #: FUROSL06121
• Secondary ID: U1111-1127-0839
• Status: Completed
• Phase: Phase 1
• First received: October 30, 2012
• Last updated: February 11, 2013
• Start date: November 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

• To determine the absolute bioavailability of furosemide 500 mg (Lasix® Special) oral formulation in patients with chronic renal failure undergoing peritoneal dialysis.

Secondary Objectives:

• To determine the pharmacokinetic profiles of furosemide 500 mg (Lasix® Special) oral formulation and 250 mg IV formulation

• To compare the pharmacodynamic characteristics of furosemide 500 mg (Lasix® Special) oral formulation and 250 mg IV formulation

Description:

• Screening: 7 to 10 days

• Treatment period: 14 days (Period 1: 7 days; Period 2: 7 days)

• End of study: 7 days after the last dosing,

• Total duration from screening per subject: 22 to 25 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria :

• Male or female, 18 years old or older, with chronic renal failure undergoing peritoneal dialysis for at least 3 months.

• Women of childbearing age should have a negative pregnancy test before administration of the study drug

Exclusion criteria:

• Contra-indications to furosemide, including:

• Hypersensitivity to furosemide or to sulphonamide-derived drugs or to any ingredient in the formulation or component of the container.

• Glomerular filtration rate below 5 mL/min

• Glomerular filtration rate above 20 mL/min

• Severe liver disease

• Patients with renal failure accompanied by hepatic coma and precoma

• Renal failure due to poisoning with nephrotoxic or hepatotoxic substances

• Severe hyponatremia, hypokalemia, hypovolemia, dehydration or hypotension

• Nursing women

• Pregnancy

• Treatment with any diuretic, which cannot be discontinued with the required washout period before the first drug administration

• Existence of any surgical or medical condition, which, in the judgment of the clinical investigator, might interfere with absorption, distribution, metabolism or excretion of drugs.

• Psychiatric or cognitive disturbance or illness, or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance.

• Treatment with the following inhibitors of secretion at the renal level:

clarithromycin, erythromycin, itraconazole, cyclosporin, ketoconazole, quinidine, and verapamil, which cannot be discontinued during the course of the study.

Interfering substance:Subjects must abstain from alcohol and beverages containing stimulating xanthine derivates (e.g. coffee and tea) during the entire study period.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• FUROSEMIDE
Pharmaceutical form: Solution Route of administration: Intravenous
• FUROSEMIDE (HOE058)
Pharmaceutical form: Tablet Route of administration: Oral

Locations

Country	Name	City	State
Canada	Investigational Site Number 124002	Montreal

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute bioavailability (F) of a single 500-mg oral tablet		Day 1, 4, 8, 11	No
Secondary	To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Cmax (maximum (peak) plasma drug concentration) after single dose administration		Day 1, 4, 8, 11	No
Secondary	To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Tmax (time to reach peak or maximum concentration) following drug administration		Day 1, 4, 8, 11	No
Secondary	To determine the pharmacokinetic parameters of furosemide (po and iv) measured by AUCT 0-72 (area under curve from the time zero to 72h)		Day 1, 4, 8, 11	No
Secondary	To determine pharmacodynamic characteristics of furosemide (po and iv) including the excretion against time of urinary volume, urinary excretion, urea and creatinine		0, 6, 12, 24 h	No