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Label indication FUROSCIX is indicated for the treatment of edema in pediatric patients weighing 43 kg and above and in adult patients adult patients with chronic heart failure or chronic kidney disease (CKD), including the nephrotic syndrome. FDA label
Also known as Furosemide Special Injection
FUROSEMIDE · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Furosemide PO - IV | EXPERIMENTAL | 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) |
| Furosemide IV - PO | EXPERIMENTAL | 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) |
| Name | Type | Description |
|---|---|---|
| FUROSEMIDE | DRUG | Pharmaceutical form: Solution Route of administration: Intravenous |
| FUROSEMIDE (HOE058) | DRUG | Pharmaceutical form: Tablet Route of administration: Oral |
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 furo...
Furosemide is a small molecule being studied in renal failure, specifically in patients with chronic renal failure undergoing peritoneal dialysis. A Phase 1 trial evaluated a high dosage formulation of furosemide in this patient population. Furosemide is a well established diuretic, and this program explores its use in the renal failure setting.
Furosemide targets SLC12A1, also known as the sodium-potassium-chloride cotransporter 2. It acts as an inhibitor of this target. By inhibiting SLC12A1 in the kidney, furosemide reduces sodium reabsorption, which increases urine output and is the basis for its diuretic activity in renal failure patients.
Sanofi, which trades under the ticker SNY, is the developer associated with this furosemide program. The company sponsored the clinical evaluation of a high dosage furosemide formulation in patients with chronic renal failure undergoing peritoneal dialysis, conducted in Canada.
Furosemide is in Phase 1 development for renal failure. The program includes one completed Phase 1 trial, and no active trials are currently listed. Furosemide is an investigational agent in this specific development program and has not been approved for the renal failure indication described here.
One clinical trial has evaluated furosemide in renal failure: NCT01724788, titled Pharmacokinetic Profile and Pharmacodynamic Characteristics of a Furosemide High Dosage Formulation in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis. The Phase 1 trial was completed, enrolled 12 participants, was randomized and controlled, and was conducted in Canada.