Clinical Trials Logo
  1. Home
  2. Iron Deficiency Anaemia
  3. NCT02962648

An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) — FERWON-EXT  

Iron Deficiency Anemia Clinical Trial

Official title:
An Open-label, Multicentre, Extension Trial to Assess the Safety of Re-dosing of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)

Clinical Trial Summary

Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.

Clinical Trial Description

Among the various formulations of parenteral iron that are currently available, iron isomaltoside/ferric derisomaltose may allow flexibility in terms of high and rapid dosing. Up to now, most clinical trials with intravenous (IV) iron treatment were of 4-12 weeks in duration; longer trials are warranted to follow-up on long-term safety.

The aim of the trial was to evaluate the safety and efficacy of IV iron isomaltoside/ferric derisomaltose re-dosing in subjects who were previously treated with iron isomaltoside/ferric derisomaltose in lead-in trials.

This was a 6-months extension trial lasting 26 weeks. Eligible subjects attended 5 visits: screening, baseline (subjects treated with a single IV dose of 1000 mg iron isomaltoside/ferric derisomaltose), and follow-up visits at week 2, 13, and 26 weeks after the IV dose, for safety and efficacy assessments. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02962648
Study type Interventional
Source Pharmacosmos A/S
Contact
Status Completed
Phase Phase 3
Start date January 9, 2017
Completion date June 12, 2018
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