Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation

NCT ID: NCT03769441

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-02
• Study Completion Date: 2024-08-19

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.

Detailed Description

Rationale: Iron deficiency is common in kidney transplant recipients. The presence of iron deficiency is associated with an unfavourable prognosis in these patients. In patients with heart failure and iron deficiency, treatment with intravenous iron improved exercise capacity and quality of life. Whether such beneficial effects may also occur in kidney transplant recipients is unknown.

Objective: Our main objective is to address whether correction of iron deficiency with ferric(III) carboxymaltose improves exercise tolerance and quality of life in iron-deficient kidney-transplant recipients.

Study design: A multicentre double-blind, placebo-controlled randomized controlled clinical trial will be performed to compare the effects of ferric(III) carboxymaltose with placebo.

Study population: 158 iron-deficient kidney transplant recipients. The intervention arm will receive 10 mL of ferric(III) carboxymaltose (50 mg Fe3/mL, intravenously) every six weeks, with a total of four dosages. The control arm receives an intravenous placebo solution (saline).

Main study parameters/endpoints: The primary endpoint is the distance walked in six minutes, as quantified by the six-minute-walking-test at the end of follow-up.

The investigators expect that iron-deficient kidney transplant recipients will benefit from ferric(III) carboxymaltose treatment as a result of an improvement in exercise tolerance and general wellbeing.

Conditions

Iron-deficiency; Transplant-Related Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ferric(III) carboxymaltose

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.

Group Type: ACTIVE_COMPARATOR

Ferric carboxymaltose

Intervention Type: DRUG

Four intravenous dosages of ferric(III) carboxymaltose

Placebo

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

Group Type: PLACEBO_COMPARATOR

Sodium chloride

Intervention Type: DRUG

Four intravenous dosages of sodiumchloride

Interventions

Ferric carboxymaltose

Four intravenous dosages of ferric(III) carboxymaltose

Intervention Type: DRUG

Sodium chloride

Four intravenous dosages of sodiumchloride

Intervention Type: DRUG

Other Intervention Names

Placebo

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Kidney Foundation

OTHER

Sponsor Role: collaborator

Vifor Fresenius Medical Care Renal Pharma

INDUSTRY

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Martin H. de Borst

Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin de Borst, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

University Medical Center Utrecht

Utrecht, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 36948568 (View on PubMed)

Other Identifiers

201800450

Identifier Type: -

Identifier Source: org_study_id