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

NCT05098249 | Completed Phase 4

• 1 other identifier: 2021-00383
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anemia; Iron-deficiency; Hypophosphatemia

Keywords

iron-deficiency anemia; hypophosphatemia; elective surgery; iron-deficiency; preoperative iron substitution; phosphate substitution

Outcome Measures

Primary Outcomes (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.

  3 years

Secondary Outcomes (2)

• Perioperative hemoglobin concentration

  3 years

• Core muscle strength

  3 years

Study Arms (2)

Verum

EXPERIMENTAL

Drug: Verum

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Verum DRUG

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

Verum

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Donat R. Spahn: lead
• University of Zurich: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related 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.

  PMID: 26192787 RESULT

• 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.

  PMID: 28382661 RESULT

• 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.

  PMID: 23505057 RESULT

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency; Hypophosphatemia

Interventions

calcium D-pantothenate, L-cysteine drug combination

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Phosphorus Metabolism Disorders

Study Officials

• Donat R Spahn, Prof. Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 28, 2021
• Study Start: November 11, 2021
• Primary Completion: May 9, 2023
• Study Completion: May 23, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)