hypophosphatemia following IV iron therapy in IDA due to IBD
Research type
Research Study
Full title
A randomized, double-blinded, comparative trial comparing the incidence of hypophosphatemia in relation to repeated treatment courses of iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia due to inflammatory bowel disease
IRAS ID
236810
Contact name
Tariq Iqbal
Contact email
Sponsor organisation
Pharmacosmos A/S
Eudract number
2017-002452-87
Clinicaltrials.gov Identifier
36695, NIHR
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Treatment with iron compounds is known to cause a decrease in the phosphate levels in the blood (hypophosphatemia). Usually, there are no symptoms associated with low blood phosphate levels. In rare cases and when the level becomes very low, symptoms such as fatigue, muscle weakness, and bone pain may occur.
The main aim of the trial is to compare the frequency of hypophosphatemia following treatment for iron deficiency anaemia (low red blood cell count due to low iron levels) caused by swelling in the lower gut (known as inflammatory bowel disease, IBD) with either iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®). During the study safety and effectiveness of treatment, and changes in symptoms usually associated with low phosphate levels will also be assessed.
A total of 120 participants will be recruited in total across Europe. At least 5 UK study sites will take part in the study.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0007
Date of REC Opinion
19 Feb 2018
REC opinion
Further Information Favourable Opinion