Who is sponsoring NCT03237065?

NCT03237065 is sponsored by Pharmacosmos A/S.

What drugs are being tested in NCT03237065?

Interventions in NCT03237065: Iron isomaltoside/ferric derisomaltose, Ferric carboxymaltose.

What condition does NCT03237065 study?

NCT03237065 studies Iron Deficiency Anaemia, Iron Deficiency Anemia.

Is NCT03237065 still recruiting?

NCT03237065 is currently completed. Last updated 25 February 2020.

Are results published for NCT03237065?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-02-25 · How we verify

NCT03237065

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 25 February 2020

What this trial tests

Phase 3 trial testing Iron isomaltoside/ferric derisomaltose in Iron Deficiency Anaemia in 122 participants. Completed in 29 May 2018.

Timeline

30 October 2017

Primary endpoint
29 May 2018

29 May 2018

Quick facts

Lead sponsor	Pharmacosmos A/S
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	122
Start date	30 October 2017
Primary completion	29 May 2018
Estimated completion	29 May 2018
Sites	15 locations across United States

Drugs / interventions tested

Iron isomaltoside/ferric derisomaltose — full drug profile →
Ferric carboxymaltose (FERRIC CARBOXYMALTOSE) — full drug profile →

Conditions studied

Iron Deficiency Anaemia — all drugs for Iron Deficiency Anaemia →
Iron Deficiency Anemia — all drugs for Iron Deficiency Anemia →

Sponsor

Pharmacosmos A/S — full company profile →

Who can join

18 and older, any sex, with Iron Deficiency Anaemia or Iron Deficiency Anemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL) Primary · 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.

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	5
Ferric Carboxymaltose	42

Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL) Secondary · 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.

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	11	6 – 28
Ferric Carboxymaltose	28	15 – 61

Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL) Secondary · Baseline to day 35

Safety Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level \<2.0 mg/dL) on day 35.

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	0
Ferric Carboxymaltose	25

Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35 Secondary · 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.

Day 1

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	0.19	± 0.57
Ferric Carboxymaltose	-0.18	± 0.50

Day 7

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-0.44	± 0.57
Ferric Carboxymaltose	-0.89	± 0.74

Day 8

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-0.46	± 0.64
Ferric Carboxymaltose	-1.14	± 0.74

Day 14

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-0.32	± 0.60
Ferric Carboxymaltose	-1.47	± 0.80

Day 21

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-0.09	± 0.66
Ferric Carboxymaltose	-1.27	± 0.88

Day 35

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	0.11	± 0.49
Ferric Carboxymaltose	-0.99	± 0.96

Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35 Secondary · 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.

Day 1

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	6.89	± 16.02
Ferric Carboxymaltose	-4.34	± 15.28

Day 7

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-11.99	± 15.38
Ferric Carboxymaltose	-25.83	± 20.54

Day 8

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-12.32	± 18.50
Ferric Carboxymaltose	-33.36	± 19.95

Day 14

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-8.66	± 16.27
Ferric Carboxymaltose	-43.54	± 22.00

Day 21

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-1.23	± 19.15
Ferric Carboxymaltose	-37.71	± 24.87

Day 35

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	3.88	± 14.19
Ferric Carboxymaltose	-28.63	± 28.14

Change From Baseline in Fractional Phosphate Urinary Excretion Secondary · 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 %.

Day 1

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	0.54	± 4.26
Ferric Carboxymaltose	1.77	± 5.15

Day 7

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	1.33	± 5.04
Ferric Carboxymaltose	4.90	± 6.48

Day 8

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	2.29	± 5.18
Ferric Carboxymaltose	6.05	± 5.71

Day 14

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-0.11	± 4.59
Ferric Carboxymaltose	8.50	± 8.95

Day 21

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-0.04	± 4.18
Ferric Carboxymaltose	6.42	± 6.70

Day 35

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	1.07	± 4.96
Ferric Carboxymaltose	5.21	± 7.74

Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35 Secondary · 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.

Day 1

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-4.18	± 18.20
Ferric Carboxymaltose	93.38	± 88.21

Day 7

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	16.97	± 45.44
Ferric Carboxymaltose	33.60	± 57.37

Day 8

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	8.09	± 36.06
Ferric Carboxymaltose	259.16	± 210.82

Day 14

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-5.35	± 24.09
Ferric Carboxymaltose	74.07	± 90.35

Day 21

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-9.13	± 28.95
Ferric Carboxymaltose	54.49	± 74.78

Day 35

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-9.17	± 23.87
Ferric Carboxymaltose	10.52	± 39.94

Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35 Secondary · 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.

Day 1

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-677.38	± 758.35
Ferric Carboxymaltose	-843.21	± 1756.37

Day 7

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-692.44	± 800.04
Ferric Carboxymaltose	-924.44	± 1748.37

Day 8

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-753.40	± 803.63
Ferric Carboxymaltose	-853.50	± 1877.89

Day 14

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-740.37	± 822.35
Ferric Carboxymaltose	-925.02	± 1783.26

Day 21

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-743.99	± 805.24
Ferric Carboxymaltose	-986.30	± 1815.76

Day 35

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-737.46	± 791.86
Ferric Carboxymaltose	-943.91	± 1741.96

Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35 Secondary · 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.

Day 1

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-0.39	± 1.86
Ferric Carboxymaltose	-0.25	± 2.50

Day 7

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-0.39	± 3.17
Ferric Carboxymaltose	0.61	± 3.30

Day 8

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-0.92	± 3.51
Ferric Carboxymaltose	0.83	± 3.56

Day 14

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-1.46	± 4.11
Ferric Carboxymaltose	0.67	± 3.83

Day 21

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-1.23	± 4.65
Ferric Carboxymaltose	0.13	± 4.11

Day 35

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-0.43	± 6.10
Ferric Carboxymaltose	-0.66	± 4.60

Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35 Secondary · 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.

Day 1

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	5.89	± 10.60
Ferric Carboxymaltose	-16.97	± 13.29

Day 7

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-16.78	± 17.81
Ferric Carboxymaltose	-23.92	± 30.68

Day 8

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-12.93	± 17.81
Ferric Carboxymaltose	-35.59	± 26.05

Day 14

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-0.40	± 16.54
Ferric Carboxymaltose	-36.14	± 26.40

Day 21

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	0.33	± 16.11
Ferric Carboxymaltose	-24.02	± 29.00

Day 35

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	0.05	± 15.33
Ferric Carboxymaltose	-12.67	± 25.01

Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35 Secondary · Baseline, days 1, 7, 8, 14, 21, and 35

Safety Change in 24,25-Dihydroxyvitamin D (vitamin D 24.25) from baseline to days 1, 7, 8, 14, 21, and 35.

Day 1

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	0.02	± 0.45
Ferric Carboxymaltose	0.07	± 0.32

Day 7

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	0.31	± 0.84
Ferric Carboxymaltose	0.26	± 0.49

Day 8

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	0.22	± 0.84
Ferric Carboxymaltose	0.38	± 0.46

Day 14

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	0.10	± 0.75
Ferric Carboxymaltose	0.55	± 0.68

Day 21

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	0.01	± 0.55
Ferric Carboxymaltose	0.50	± 0.76

Day 35

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	0.00	± 0.77
Ferric Carboxymaltose	0.23	± 0.65

Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35 Secondary · Baseline, days 1, 7, 8, 14, 21, and 35

Safety Change in intact Parathyroid hormone (PTH) from baseline to days 1, 7, 8, 14, 21, and 35.

Day 1

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-0.07	± 18.93
Ferric Carboxymaltose	-7.02	± 25.83

Day 7

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-1.72	± 24.41
Ferric Carboxymaltose	0.73	± 29.37

Day 8

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-0.17	± 21.03
Ferric Carboxymaltose	-3.26	± 27.12

Day 14

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	7.39	± 24.17
Ferric Carboxymaltose	22.22	± 31.14

Day 21

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	0.67	± 19.36
Ferric Carboxymaltose	22.80	± 38.82

Day 35

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	-1.58	± 22.86
Ferric Carboxymaltose	22.19	± 33.21

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Iron Isomaltoside/Ferric Derisomaltose

Serious: 0/62 (0%)

Deaths: 0/62

Ferric Carboxymaltose

Serious: 1/57 (2%)

Deaths: 0/57

Serious adverse events (1 terms)

Reaction	System	Iron Isomaltoside/Ferric D…	Ferric Carboxymaltose
Dehydration	Metabolism and nutrition disorders	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	Iron Isomaltoside/Ferric D…	Ferric Carboxymaltose
Hypophosphatemia	Metabolism and nutrition disorders	—	—
Blood phosphorus decreased	Investigations	—	—
Nausea	Gastrointestinal disorders	—	—
Blood parathyroid hormone increased	Investigations	—	—
Vitamin D deficiency	Metabolism and nutrition disorders	—	—
Headache	Nervous system disorders	—	—
Serum ferritin increased	Investigations	—	—
Vomiting	Gastrointestinal disorders	—	—

Most-reported serious reactions: Dehydration.

Data from ClinicalTrials.gov NCT03237065 adverse events section.

Sponsor's own description

The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (IDA).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials.
Wolf M, Rubin J, Achebe M, Econs MJ, et al · · 2020 · cited 189× · PMID 32016310 · DOI 10.1001/jama.2019.22450
Risk Factors for and Effects of Persistent and Severe Hypophosphatemia Following Ferric Carboxymaltose.
Schaefer B, Zoller H, Wolf M. · · 2022 · cited 34× · PMID 34850000 · DOI 10.1210/clinem/dgab852
Intravenous ferric derisomaltose for the treatment of iron deficiency anemia.
Auerbach M, Henry D, DeLoughery TG. · · 2021 · cited 25× · PMID 33580972 · DOI 10.1002/ajh.26124
Clinical data for intravenous iron - debunking the hype around hypersensitivity.
Achebe M, DeLoughery TG. · · 2020 · cited 25× · PMID 32479668 · DOI 10.1111/trf.15837

Verify or expand the search:

Other trials of Iron isomaltoside/ferric derisomaltose

Trials testing the same drug.

NCT03238911 — Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Su · Phase 3 · completed
NCT02962648 — An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) · Phase 3 · completed
NCT02940860 — Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent · Phase 3 · completed
NCT02940886 — Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA) · Phase 3 · completed

Other recruiting trials for Iron Deficiency Anaemia

Currently open trials in the same condition.

NCT05990166 — Assessing the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age · Phase 2 · active not recruiting

Other Pharmacosmos A/S trials

Trials by the same sponsor.

NCT06929806 — Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chroni · Phase 3 · recruiting
NCT05545202 — A Randomized, Comparative, Double-blind Trial of Pentaisomaltose and Dimethyl Sulphoxide for Cryoprotection of Hematopoi · Phase 4 · not yet recruiting
NCT05874401 — Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan · Phase 4 · recruiting
NCT05179226 — Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia · Phase 3 · recruiting
NCT03466983 — A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxyma · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03237065 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pharmacosmos A/S
Last refreshed: 25 February 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03237065.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03237065

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Iron isomaltoside/ferric derisomaltose

Other recruiting trials for Iron Deficiency Anaemia

Other Pharmacosmos A/S trials

Verify against primary sources