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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Renal Failure

Treatments: Drug: FUROSEMIDE; Drug: FUROSEMIDE (HOE058)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01724788

FUROSL06121

U1111-1127-0839 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Furosemide PO - IV

Experimental group

Description:

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)

Treatment:

Drug: FUROSEMIDE (HOE058)

Drug: FUROSEMIDE

Furosemide IV - PO

Experimental group

Description:

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)

Treatment:

Drug: FUROSEMIDE (HOE058)

Drug: FUROSEMIDE