To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose

Status Completed

Clinical Trial Summary

The primary objective is to demonstrate the efficacy of ferric carboxymaltose (FCM) given in a simple dosing regimen in correcting iron deficiency anaemia (IDA), by demonstrating non-inferiority to treatment with the currently approved intravenous (IV) iron therapy of iron sucrose (IS, Venofer™) in the Chinese population. The secondary objectives are to assess the safety of FCM compared to IS in the Chinese population and to evaluate the effect of FCM compared to IS on relevant laboratory parameters (haematology, chemistry, iron parameters) in the Chinese population.

Clinical Trial Description

This is an open-label, randomised controlled study to assess the impact of FCM in correcting iron deficiency anaemia compared with Venofer™ (IS). All subjects, after providing written informed consent and meeting the eligibility assessments, will receive a first dose of IV iron as either FCM or IS. A total of approximately 368 subjects (184 per group) will be enrolled. All subjects will have iron deficiency anaemia as measured by haemoglobin (Hb), serum ferritin and transferrin saturation (TSAT) at screening. Ferric carboxymaltose will be administered as either a diluted infusion or undiluted injection (at Investigator discretion) and IS will be administered as a slow intravenous injection at a rate of 1 ml undiluted solution per minute (with each single injection of 200 mg iron) or by drip infusion. Note, for subjects randomised to receive IS dosing visits are required three times a week to achieve total iron repletion dosing as calculated using the Ganzoni formula. For subjects randomised to FCM, the total iron requirements will be calculated at screening based on the screening Hb and subject weight. Dosing will be at baseline and, if required, at day 8 and day 15. All subjects will attend study visits at screening, baseline and thereafter at Weeks 2, 4 and 6. All subjects will attend an end of study visit (at Week 8 - or earlier if discontinued prematurely). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03591406
Study type	Interventional
Source	Vifor Pharma
Contact
Status	Completed
Phase	Phase 3
Start date	July 3, 2017
Completion date	February 25, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06027801` - Iron Fortified Food to Improve Japanese Encephalitis and Typhoid Fever Vaccine Immunogenicity	N/A
Completed	`NCT02282553` - Gastric Capsule Examination for Iron Deficiency Anaemia	N/A
Recruiting	`NCT05217836` - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Recruiting	`NCT04913649` - Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients	Phase 4
Completed	`NCT02176759` - Iron Absorption From Rice Fortified With Ferric Pyrophosphate	N/A
Completed	`NCT01438645` - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy	N/A
Completed	`NCT01307007` - Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding	Phase 2
Completed	`NCT00982007` - Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)	Phase 3
Completed	`NCT00198848` - Iron Supplementation Among Adolescent Girls in India	N/A
Completed	`NCT01166451` - The Anemia Control Program: High or Low Iron Supplementation	N/A
Recruiting	`NCT03893045` - A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects	Phase 3
Recruiting	`NCT03817957` - Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency	Phase 3
Completed	`NCT03819530` - Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study	N/A
Completed	`NCT03618914` - Anemia and Inflammation
Completed	`NCT03940430` - Lactoferrin Versus Ferrous Sulfate in Management of Iron Deficiency Anemia Among Female Medical Ain Shams Students	Phase 2/Phase 3
Withdrawn	`NCT03873584` - Improvement of Fatigue Symptoms in the Iron Deficiency Anemia With Iron Succinylate Therapy
Enrolling by invitation	`NCT03897673` - Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas	N/A
Active, not recruiting	`NCT04778072` - A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects	N/A
Completed	`NCT03237065` - Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia	Phase 3
Completed	`NCT05153278` - IV Iron Versus Standard Treatment for Iron Deficiency Anemia in the Emergency Department

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms