Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation

NCT03769441 | Completed Phase 3 DMC

• 1 other identifier: 201800450
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

Brief Summary

Iron deficiency is common in kidney transplant recipients and is associated with impaired exercise tolerance and an unfavourable prognosis. This multicentre double-blind, placebo-controlled randomized controlled clinical trial will allow the investigators to analyse the effects of intravenous iron correction with ferric(III) carboxymaltose on exercise tolerance and other parameters, in comparison to a placebo.

Conditions

Iron-deficiency; Transplant-Related Disorder

Keywords

Renal Transplantation; Kidney Transplantation; Iron Deficiency

Outcome Measures

Primary Outcomes (1)

• Exercise tolerance

  The between-group difference in change in exercise tolerance quantified by the six-minute walk test (6MWT)

  24 weeks

Secondary Outcomes (40)

• Hemoglobin level

  24 weeks

• Iron status

  24 weeks

• Cardiac function

  24 weeks

• Muscle strength 1

  24 weeks

• Muscle strength 2

  24 weeks

Study Arms (2)

Ferric(III) carboxymaltose

ACTIVE COMPARATOR

The intervention group will be treated with four dosages of 500 mg iron in the form of 10 mL ferric(III) carboxymaltose dissolved in 240 mL of NaCl 0.9%, with interval periods of six weeks.

Drug: Ferric carboxymaltose

Placebo

PLACEBO COMPARATOR

The placebo-controlled group will receive four dosages of 250 mL of NaCl 0.9% solution with interval periods of six weeks.

Drug: Sodium chloride

Interventions

Ferric carboxymaltose DRUG

Four intravenous dosages of ferric(III) carboxymaltose

Ferric(III) carboxymaltose

Sodium chloride DRUG

Four intravenous dosages of sodiumchloride

Also known as: Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Kidney transplant recipient
• Iron deficiency, defined by a ferritin level of ≤100 ug/L, or 100-299 ug/L combined with a transferrin saturation of ≤20%
• At least six months after transplantation at baseline
• Age ≥18 years
• Ability to comply with the study protocol
• Informed consent

You may not qualify if:

• Intolerance to any intravenous iron solution
• Severe anemia (Hb \<10.5 g/dL, \<6.5 mmol/L), microcytic anemia (MCV \<80 fl) or progressive anemia (˃3.2 g/dL per month decline for two months or more)
• A positive feces occult blood test or otherwise demonstrated gastrointestinal, or urogenital, blood loss
• Blood transfusion in the past six weeks
• Polycythemia (Hb \>15.3 g/dL, 9.5 mmol/L)
• Estimated glomerular filtration rate (eGFR) of ≤ 30 ml/min per 1.73 m2
• History of haemochromatosis
• Unstable angina or myocardial infarction during the previous month
• Disability to walk
• Severe hypophosphatemia in the month before baseline (serum phosphate \<0.35 mmol/L)
• Pregnancy or inability to take adequate contraceptive measures when at childbearing age (women)
• Any signs of an active systemic infection
• Participation in another interventional study

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Dutch Kidney Foundation: collaborator
• Vifor Fresenius Medical Care Renal Pharma: collaborator

Study Sites (2)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

Related Publications (1)

• Vinke JS, Eisenga MF, Sanders JF, Berger SP, Spikman JM, Abdulahad WH, Bakker SJ, Gaillard CAJM, van Zuilen AD, van der Meer P, de Borst MH. Effect of Intravenous Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation (EFFECT-KTx): rationale and study protocol for a double-blind, randomised, placebo-controlled trial. BMJ Open. 2023 Mar 22;13(3):e065423. doi: 10.1136/bmjopen-2022-065423.

  PMID: 36948568 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

ferric carboxymaltose; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Martin de Borst, MD/PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants, care providers and researchers will be blinded, except for the nurse who will administer the medication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: The study is designed as a 24 week, multicentre, randomized placebo-controlled clinical trial with two parallel arms to investigate the effect of ferric(III) carboxymaltose on exercise tolerance, cardiac function, skeletal muscle function, quality of life, the gut microbiota and on the immune system, to be performed at the University Medical Center Groningen (UMCG) and the Erasmus MC, University Medical Center Rotterdam.

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 7, 2018
• Study Start: August 2, 2019
• Primary Completion: August 19, 2024
• Study Completion: August 19, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The study protocol, including a statistical data analysis plan, will be published in a peer-reviewed journal.

Locations

NL (2)