AzTrials
AzTrials

AnemiaPhase 4NCT05098249

Ferric Carboxymaltose With or Without Phosphate Substitution for the Treatment of Iron Deficiency or Iron Deficiency Anemia

A Phase 4 study testing Verum in people with Anemia and Iron-deficiency, run by Donat R. Spahn at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a confirmatory trial to establish superior serum phosphate stability associated with use of Phoscap® compared with placebo as a supplement for treatment of iron deficiency or iron deficiency anemia with Ferinject® before elective surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia, Iron-deficiency, Hypophosphatemia
What is being tested?
Verum
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
1 siteSwitzerland
Study dates
11 Nov 2021to 23 May 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed Consent as documented by signature (Appendix 5: Informed Consent Form)
  • Male or female ASA 1 to 3 patients, at least 18 years old
  • Scheduled for an elective major abdominal or thoracic surgery.
  • Patients with isolated iron deficiency (defined as hemoglobin concentration (Hb) > 130 g/l, and plasma Ferritin < 100 ng/ml or TSAT < 20%), or iron deficiency anemia (defined as Hb 100-130 g/l, and plasma Ferritin < 100 ng/ml or TSAT < 20%).
  • Patients scheduled to be hospitalized ≥ 3 days.

Who cannot join

  • Patients with known anaphylactic reactions to parenteral iron products. Patients with allergy/hypersensitivity to any contents of Ferinject® or Phoscap®.
  • Patients with iron overload or disturbances in utilization of iron (e.g. haemochromatosis, hemosiderosis).
  • Patients with ≥3 times increase in aspartate aminotransferase or alanine aminotransferase as per reference range.
  • Patients with excessive blood loss requiring massive transfusion (≥ 10 more red blood cell units).
  • Patients with known myelodysplastic syndromes.
  • Patients with chronic kidney disease with an estimated GFR < 30 ml/min or with end-stage renal disease requiring scheduled dialysis.
Show all 17Show fewer
  • Patients with known urinary tract infections with urea-splitting bacteria.
  • Patients with known diseases influencing phosphate, calcium or vitamin D homeostasis (e.g. Hyperparathyroidism, X-linked hypophosphatemia, renal tubular acidosis).
  • Patients taking medication significantly influencing phosphate, calcium or vitamin D homeostasis (e.g. vitamin D substitution > 800 I.E. per day in the last 4 months, pre-existing phosphate substitution, phosphate binders).
  • Patients with preexisting hypophosphatemia
  • Any patient judged to lack the ability to give informed consent or perform the trial assessments (e.g. due to dementia, insufficient knowledge of the German language).
  • Women who are pregnant or breast feeding,
  • Intention to become pregnant during the course of the study,
  • Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Female participants who are surgically sterilized / hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential),
  • Known or suspected non-compliance, drug or alcohol abuse.
  • Participation in another study with investigational drug within the 30 days preceding and during the present study.
  • Any patient judged by the Principal Investigator or Sub-Investigator to be inappropriate for the trial for any other reason.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Ferric Carboxymaltose With or Without Phosphate Substitution for the Treatment of Iron Deficiency or Iron Deficiency Anemia Before Elective Surgery - the DeFICIT Trial

This is a confirmatory trial to establish superior serum phosphate stability associated with use of Phoscap® compared with placebo as a supplement for treatment of iron deficiency or iron deficiency anemia with Ferinject® before elective surgery.

Read the detailed description

Iron deficiency anemia is a global health problem most commonly caused by excessive blood loss, impaired intestinal iron absorption, or chronic inflammation. In the perioperative setting, intravenous ferric carboxymaltose allows efficient treatment of preoperative iron deficiency and anemia. Recent studies have implied that ferric carboxymaltose might cause hypophosphatemia. Notably, hypophosphatemia has been associated with less muscle strength, which may influence early post-surgery recovery of patients. Additional oral phosphate supplementation may alleviate this hypophosphatemia.

This is a confirmatory trial to establish superior serum phosphate stability associated with use of Phoscap® compared with placebo as a supplement for treatment of iron deficiency or iron deficiency anemia with Ferinject® before elective surgery.

This is also a confirmatory trial to establish non-inferior efficacy of Phoscap® compared with placebo for the treatment of iron deficiency or iron deficiency anemia with Ferinject®; and to establish superior core muscle strength associated with the use of Phoscap® compared with placebo.

Being tested
Verum, Placebo
Keywords
iron-deficiency anemia, hypophosphatemia, elective surgery, iron-deficiency, preoperative iron substitution, phosphate substitution
Medical subject headings
Anemia, Anemia, Iron-Deficiency, Hypophosphatemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VerumDrug

    The participant takes two capsules Phoscap® (3mmol/capsule) orally three times a day over 30 days beginning the day of Ferinject administration.

  • PlaceboDrug

    The participant takes wo capsules Placebo orally three times a day over 30 days beginning the day of Ferinject administration.

Study groups in NCT05098249
Study groupRoleWhat they receive
VerumExperimentalNot described
Receives: Drug: Verum
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Establish superior serum phosphate stability

    The primary endpoint is superior serum phosphate stability. The investigators measure perioperative phosphate concentrations in participants during the follow-up visits and compare the results between verum and placebo group.

    Measured: 3 years

Secondary outcomes (2)

  1. Perioperative hemoglobin concentration

    Mean perioperative Hb of the day of surgery, post-operative day (POD)2 and POD4.

    Measured: 3 years

  2. Core muscle strength

    Pre- and postoperative assessment of core muscle strength by volitional testing of maximal inspiratory and expiratory pressures.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2021
  2. Study start11 Nov 2021
  3. Primary completion9 May 2023
  4. Study completion23 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05098249
Sponsor's protocol ID
2021-00383
Status last verified
May 2023
First submitted
14 Oct 2021
Last updated
24 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Munoz M, Gomez-Ramirez S, Campos A, Ruiz J, Liumbruno GM. Pre-operative anaemia: prevalence, consequences and approaches to management. Blood Transfus. 2015 Jul;13(3):370-9. doi: 10.2450/2015.0014-15. Epub 2015 Jun 16. No abstract available.

    PubMed 26192787

  • Munoz M, Laso-Morales MJ, Gomez-Ramirez S, Cadellas M, Nunez-Matas MJ, Garcia-Erce JA. Pre-operative haemoglobin levels and iron status in a large multicentre cohort of patients undergoing major elective surgery. Anaesthesia. 2017 Jul;72(7):826-834. doi: 10.1111/anae.13840. Epub 2017 Apr 6.

    PubMed 28382661

  • Wolf M, Koch TA, Bregman DB. Effects of iron deficiency anemia and its treatment on fibroblast growth factor 23 and phosphate homeostasis in women. J Bone Miner Res. 2013 Aug;28(8):1793-803. doi: 10.1002/jbmr.1923.

    PubMed 23505057

  • Kaserer A, Braun J, Mair A, Akbas S, Rossler J, Bischoff-Ferrari HA, Turina M, Clavien PA, Opitz I, Hulsmeier A, Karsai G, Gasciauskaite G, Spahn GH, Schlapfer M, Spahn DR. Ferric carboxymaltose with or without phosphate substitution in iron deficiency or iron deficiency anemia before elective surgery - The DeFICIT trial. J Clin Anesth. 2025 Feb;101:111727. doi: 10.1016/j.jclinane.2024.111727. Epub 2024 Dec 12.

    PubMed 39671753

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Verum in people with Anemia and Iron-deficiency, run by Donat R. Spahn at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Establish superior serum phosphate stability (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05098249, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in