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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05098249
• Other study ID #: 2021-00383
• Status: Completed
• Phase: Phase 4
• Start date: November 11, 2021
• Est. completion date: May 23, 2023

Study information

• Verified date: May 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: May 23, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Hypophosphatemia
• Iron-deficiency

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Donat R. Spahn	University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View Citation

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: — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years
Secondary	Perioperative hemoglobin concentration	Mean perioperative Hb of the day of surgery, post-operative day (POD)2 and POD4.	3 years
Secondary	Core muscle strength	Pre- and postoperative assessment of core muscle strength by volitional testing of maximal inspiratory and expiratory pressures.	3 years