To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia

PHASE3CompletedINTERVENTIONAL
Enrollment

371

Participants

Timeline

Start Date

July 3, 2017

Primary Completion Date

February 25, 2019

Study Completion Date

February 25, 2019

Conditions
Iron Deficiency Anemia
Interventions
DRUG

Ferric carboxymaltose

Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.

DRUG

Iron sucrose

Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.

Trial Locations (1)

310003

The First Affiliated Hospital, Zhejiang University, Hangzhou

All Listed Sponsors
collaborator

Tigermed Consulting Co., Ltd

INDUSTRY

lead

Vifor (International) Inc.

INDUSTRY

NCT03591406 - To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia | Biotech Hunter | Biotech Hunter