Trial · NCT03237065

Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia

NCT03237065, Phase 3, Completed, Pharmacosmos A/S; results first posted 2020-02-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia. Trials, record NCT03237065. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03237065

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
NCT number: NCT03237065
Status: Completed
Phases: Phase 3
Enrollment: 122 participants, actual
Lead sponsor: Pharmacosmos A/S
Conditions: Iron Deficiency Anaemia, Iron Deficiency Anemia
Interventions: Iron isomaltoside/ferric derisomaltose, Ferric carboxymaltose
First posted: 2017-08-02
Last updated: 2020-02-25
Results first posted: 2020-02-25

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)	Baseline to day 35	Safety The incidence of hypophosphatemia (defined as s-phosphate \<2 mg/dL) at any time from baseline up to day 35.
Secondary	Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)	Baseline to day 35	Safety Time with hypophosphatemia (i.e. time with s-phosphate level \< 2.0 mg/dL) from baseline up to day 35. The time with hypophosphatemia was calculated as the actual number of days from the first day where s-phosphate was \<2 mg/dL until the first day when s-phosphate was ≥2 mg/dL. If the subject did not reach s-phosphate ≥2 mg/dL, the subject was regarded as censored on day 35.
Secondary	Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL)	Baseline to day 35	Safety Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level \<2.0 mg/dL) on day 35.
Secondary	Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35	Baseline, days 1, 7, 8, 14, 21, and 35	Safety Absolute \[∆\] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.
Secondary	Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35	Baseline, days 1, 7, 8, 14, 21, and 35	Safety Relative \[%\] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.
Secondary	Change From Baseline in Fractional Phosphate Urinary Excretion	Baseline, days 1, 7, 8, 14, 21, and 35	Safety Change in absolute fractional phosphate urinary excretion from baseline to days 1, 7, 8, 14, 21, and 35. Fractional excretion of phosphate (FEPi) is calculated as (\[phosphate in urine X creatinine in serum\]/\[phosphate in serum X creatinine in urine\]) X 100, and the unit is %.
Secondary	Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35	Baseline, days 1, 7, 8, 14, 21, and 35	Safety Change in concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) from baseline to day 1, 7, 8, 14, 21, and 35.
Secondary	Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35	Baseline, days 1, 7, 8, 14, 21, and 35	Safety Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) from baseline to days 1, 7, 8, 14, 21, and 35.
Secondary	Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35	Baseline, days 1, 7, 8, 14, 21, and 35	Safety Change in vitamin 25-Hydroxyvitamin D (vitamin D 25) from baseline to days 1, 7, 8, 14, 21, and 35.
Secondary	Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35	Baseline, days 1, 7, 8, 14, 21, and 35	Safety Change in 1,25-Dihydroxyvitamin D (vitamin D 1.25) from baseline to days 1, 7, 8, 14, 21, and 35.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)	Baseline to day 35	Safety analysis set: included all subjects who received at least one dose of the investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)	Baseline to day 35	Safety analysis set: included all subjects who received at least one dose of the investigational product.	days	MEDIAN
SECONDARY	Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL)	Baseline to day 35	Safety analysis set: included all subjects who received at least one dose of the investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35	Baseline, days 1, 7, 8, 14, 21, and 35	Safety analysis set: included all subjects who received at least one dose of the investigational product.	mg/dL	MEAN
SECONDARY	Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35	Baseline, days 1, 7, 8, 14, 21, and 35	Safety analysis set: included all subjects who received at least one dose of the investigational product.	Percentage change from baseline	MEAN
SECONDARY	Change From Baseline in Fractional Phosphate Urinary Excretion	Baseline, days 1, 7, 8, 14, 21, and 35	Safety analysis set: included all subjects who received at least one dose of the investigational product.	percentage excreted	MEAN
SECONDARY	Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35	Baseline, days 1, 7, 8, 14, 21, and 35	Safety analysis set: included all subjects who received at least one dose of the investigational product.	pg/mL	MEAN
SECONDARY	Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35	Baseline, days 1, 7, 8, 14, 21, and 35	Safety analysis set: included all subjects who received at least one dose of the investigational product.	RU/mL	MEAN
SECONDARY	Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35	Baseline, days 1, 7, 8, 14, 21, and 35	Safety analysis set: included all subjects who received at least one dose of the investigational product.	ng/mL	MEAN
SECONDARY	Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35	Baseline, days 1, 7, 8, 14, 21, and 35	Safety analysis set: included all subjects who received at least one dose of the investigational product.	pg/mL	MEAN

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group166

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)	Iron Isomaltoside/Ferric Derisomaltose		5		Participants
Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)	Ferric Carboxymaltose		42		Participants
Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)	Iron Isomaltoside/Ferric Derisomaltose		11	95% Confidence Interval 6 to 28	days
Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)	Ferric Carboxymaltose		28	95% Confidence Interval 15 to 61	days
Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL)	Iron Isomaltoside/Ferric Derisomaltose		0		Participants
Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL)	Ferric Carboxymaltose		25		Participants
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35	Iron Isomaltoside/Ferric Derisomaltose	Day 1	0.19	Standard Deviation 0.57	mg/dL
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35	Ferric Carboxymaltose	Day 1	-0.18	Standard Deviation 0.50	mg/dL
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35	Iron Isomaltoside/Ferric Derisomaltose	Day 7	-0.44	Standard Deviation 0.57	mg/dL
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35	Ferric Carboxymaltose	Day 7	-0.89	Standard Deviation 0.74	mg/dL

1 to 10 of 166Source ClinicalTrials.gov

See all 166 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Iron Isomaltoside/Ferric Derisomaltose	61
Overall Study	STARTED	Ferric Carboxymaltose	61
Overall Study	Safety Analysis Set	Iron Isomaltoside/Ferric Derisomaltose	62
Overall Study	Safety Analysis Set	Ferric Carboxymaltose	57
Overall Study	COMPLETED	Iron Isomaltoside/Ferric Derisomaltose	57
Overall Study	COMPLETED	Ferric Carboxymaltose	57
Overall Study	NOT COMPLETED	Iron Isomaltoside/Ferric Derisomaltose	4
Overall Study	NOT COMPLETED	Ferric Carboxymaltose	4

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Blood parathyroid hormone increased	Investigations	Iron Isomaltoside/Ferric Derisomaltose	4	62	4
other	Blood parathyroid hormone increased	Investigations	Ferric Carboxymaltose	5	57	5
other	Blood phosphorus decreased	Investigations	Iron Isomaltoside/Ferric Derisomaltose	0	62	0
other	Blood phosphorus decreased	Investigations	Ferric Carboxymaltose	8	57	9
other	Serum ferritin increased	Investigations	Iron Isomaltoside/Ferric Derisomaltose	0	62	0
other	Serum ferritin increased	Investigations	Ferric Carboxymaltose	3	57	3
other	Nausea	Gastrointestinal disorders	Iron Isomaltoside/Ferric Derisomaltose	3	62	4
other	Nausea	Gastrointestinal disorders	Ferric Carboxymaltose	6	57	6
other	Vomiting	Gastrointestinal disorders	Iron Isomaltoside/Ferric Derisomaltose	1	62	1
other	Vomiting	Gastrointestinal disorders	Ferric Carboxymaltose	3	57	3

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Iron Isomaltoside/Ferric Derisomaltose	0	62
Total, all-cause mortality	Ferric Carboxymaltose	0	57
Total, other adverse events	Iron Isomaltoside/Ferric Derisomaltose	13	62
Total, other adverse events	Ferric Carboxymaltose	25	57
Total, serious adverse events	Iron Isomaltoside/Ferric Derisomaltose	0	62
Total, serious adverse events	Ferric Carboxymaltose	1	57

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32016310	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose: Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL)	Trial comparisons
Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose: Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions	Trial comparisons
Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose: Incidence of S-phosphate Level ≤1.0 mg/dL at Any Time From Baseline to Day 35	Trial comparisons
Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose: Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)	Trial comparisons
Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose: deaths from any cause	Trial comparisons
Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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