Clinical Trial: Time to Relapse of Iron Deficiency Anaemia After Standard Treatment With The Intravenous Iron (Monofer®)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: A Non-interventional Study of the Time to Relapse of Iron Deficiency Anaemia After Standard Treatment With the Intravenous Iron Monofer® (10% Iron Isomaltoside 1000)

Brief Summary: The objective is to monitor and quality assure the efficacy, including effects on quality of life, and safety of Monofer® in Chronic Kidney Disease and Inflammatory Bowel Disease patient populations when Monofer® is used according to the Monofer® label (Summary of Product Characteristics, SPC) in current clinical practice and where standard routines are being followed.

Detailed Summary:

Intravenous (IV) iron is a well-tolerated and efficacious treatment of iron deficiency anaemia in conditions such as Chronic Kidney Disease (CKD) and Inflammatory Bowel Disease (IBD). Several studies in CKD and IBD patients have shown that IV iron is superior to oral iron, most likely explained by decreased uptake and poor compliance (due to gastrointestinal side-effects) when using oral iron.

The patented Iron Isomaltoside 1000 (Monofer®) has been developed to overcome the current limitations of IV iron drugs with regards to safety and convenience of use. The possibility to administer Monofer® at high single doses (up to 20 mg/kg) reduces the number of treatment visits needed for full iron correction, which is cost-effective, resource and time-sparing, and a reduced drug exposure frequency decreases the risk of side-effects such as infusion reactions.

The objective of the study is to monitor and quality assure the efficacy, including effects on quality of life, and safety of Monofer® in CKD and IBD patient populations when Monofer® is used according to the Monofer® label (Summary of Product Characteristics, SPC) in current clinical practice and where standard routines are being followed. The scientific rationale being to fulfill a need for systematic information/auditing on applied practice including both short and long-term experience with the use of IV iron in different hospital settings and in current clinical practice. The outcome will provide an evidence base for optimised treatment procedures in terms of safety and efficacy.

The total duration of the study per site is approximately 21 months, which includes a 6 months enrollment period, a prospective observation period of at least 12 months, and a period of maximum 3 months prior to the last
Sponsor: Pharmacosmos UK Ltd

Current Primary Outcome: Time to relapse of iron deficiency anaemia [ Time Frame: From screening until 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in scores for fatigue symptoms [ Time Frame: Immediately before to earliest 4 weeks after each treatment course during 12 months ]
  • Change in anaemia-related blood parameter levels (haemoglobin, iron parameters) [ Time Frame: Immediately before to earliest 4 weeks after each treatment course during 12 months ]
  • IV iron dose (total needed dose per treatment course) [ Time Frame: From screening until 12 months ]
  • Number and seriousness of Adverse Drug Reactions [ Time Frame: From screening until 12 months ]


Original Secondary Outcome: Same as current

Information By: Pharmacosmos A/S

Dates:
Date Received: September 8, 2015
Date Started: January 2016
Date Completion: January 2018
Last Updated: September 27, 2016
Last Verified: September 2016