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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01724788
First received: October 30, 2012
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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

Condition Intervention Phase
Renal Failure
Drug: FUROSEMIDE
Drug: FUROSEMIDE (HOE058)
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Absolute bioavailability (F) of a single 500-mg oral tablet [ Time Frame: Day 1, 4, 8, 11 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Cmax (maximum (peak) plasma drug concentration) after single dose administration [ Time Frame: Day 1, 4, 8, 11 ] [ Designated as safety issue: No ]
  • To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Tmax (time to reach peak or maximum concentration) following drug administration [ Time Frame: Day 1, 4, 8, 11 ] [ Designated as safety issue: No ]
  • To determine the pharmacokinetic parameters of furosemide (po and iv) measured by AUCT 0-72 (area under curve from the time zero to 72h) [ Time Frame: Day 1, 4, 8, 11 ] [ Designated as safety issue: No ]
  • To determine pharmacodynamic characteristics of furosemide (po and iv) including the excretion against time of urinary volume, urinary excretion, urea and creatinine [ Time Frame: 0, 6, 12, 24 h ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: November 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Furosemide PO - IV
Oral furosemide allocated at the beginning of Period 1, then cross-over to IV furosemide (a minimum 7-day diuretic free washout period required between the two periods)
Drug: FUROSEMIDE
Pharmaceutical form: Solution Route of administration: Intravenous
Other Name: Furosemide Special Injection
Drug: FUROSEMIDE (HOE058)
Pharmaceutical form: Tablet Route of administration: Oral
Other Name: Lasix® Special
Experimental: Furosemide IV - PO
IV furosemide allocated at the beginning of Period 1, then cross-over to oral furosemide (a minimum 7-day diuretic free washout period required between the two periods)
Drug: FUROSEMIDE
Pharmaceutical form: Solution Route of administration: Intravenous
Other Name: Furosemide Special Injection
Drug: FUROSEMIDE (HOE058)
Pharmaceutical form: Tablet Route of administration: Oral
Other Name: Lasix® Special

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724788

Locations
Canada
Investigational Site Number 124002
Montreal, Canada, H1T 2M4
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01724788     History of Changes
Other Study ID Numbers: FUROSL06121, U1111-1127-0839
Study First Received: October 30, 2012
Last Updated: February 11, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014