A Trial Comparing the Incidence of Hypophosphatemia in Re... | NCT03466983

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2018Actual

Primary Completion Date

May 25, 2020Actual

Completion Date

May 25, 2020Actual

First Submitted Date

Mar 6, 2018

First Submission Date that Met QC Criteria

Mar 14, 2018

First Posted Date

Mar 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2021

Last Update Posted Date

Feb 21, 2021Actual

Description Module

Brief Summary

Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia due to inflammatory bowel disease and comparison of the incidence of hypophosphatemia

Detailed Description

Existing IV iron complexes differ in relation to the compounds capability to induce unintended hypophosphatemia to a degree defined as medical significant.

This trial is designed evaluate the effect of IV iron isomaltoside compared to IV ferric carboxymaltose on phosphate in subjects with IDA due to inflammatory bowel disease .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Iron Isomaltoside	Experimental	Iron Isomaltoside (Monofer) administered IV	Drug: Iron Isomaltoside
Ferric Carboxymaltose	Active Comparator	Ferric Carboxymaltose (Injectafer) administered IV	Drug: Ferric Carboxymaltose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iron Isomaltoside	Drug	administered IV	Iron Isomaltoside	Monofer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of hypophosphatemia	s-phosphate < 2 mg/dL	any time from baseline to day 35

Secondary Outcomes

Measure	Description	Time Frame
Incidence of hypophosphatemia	s-phosphate < 2 mg/dL	any time from baseline to week 10
Incidence of s-phosphate < 1.0 mg/dL	s-phosphate < 1.0 mg/dL

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria include:

Men or women ≥ 18 years
Subjects diagnosed with IBD
Hb < 13 g/dL
Body weight ≥ 50 kg
S-ferritin <100 ng/mL
eGFR ≥ 65 mL/min/1.73 m2
S-phosphate > 2.5 mg/dL
Oral iron preparations are ineffective or cannot be used or where there is a clinical need to de-liver iron rapidly
Willingness to participate and signing the Informed Consent Form (ICF)

Exclusion Criteria include:

Anaemia predominantly caused by factors other than IDA according to Investigator's judgment
Hb ≥ 10 g/dL and body weight < 70 kg
Hemochromatosis or other iron storage disorders
Known hypersensitivity reaction to any component of iron isomaltoside or ferric carboxymaltose
Previous serious hypersensitivity reactions to any IV iron compounds
Treatment with IV iron within the last 30 days prior to screening
Treatment with erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion, radiotherapy, and/or chemotherapy within the last 30 days prior to screening
Received an investigational drug within the last 30 days prior to screening
Planned surgical procedure within the trial period
hepatic enzymes > 3 times upper limit of normal
Surgery under general anaesthesia within the last 30 days prior to screening
Any non-viral infection within the last 30 days prior to screening
Alcohol or drug abuse within the past 6 months
Untreated hyperparathyroidism
Kidney transplantation
Conditions that interfere with the subject's ability to understand the requirements of the trial and/or presumable non-compliance
Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements
Pregnant or nursing women.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Pharmacosmos Investigational Site		Silkeborg		8600	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38874697	Derived	Bjorner JB, Kennedy N, Lindgren S, Pollock RF. Hypophosphatemia attenuates improvements in vitality after intravenous iron treatment in patients with inflammatory bowel disease. Qual Life Res. 2024 Aug;33(8):2285-2294. doi: 10.1007/s11136-024-03642-y. Epub 2024 Jun 14.

ID	Term
C557707	iron isomaltoside 1000
C522335	ferric carboxymaltose