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NCT Number: NCT03769441

Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation

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.

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Key information

Conditions

Iron-deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Transplant-Related Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Medical Center Groningen, Groningen, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ferric carboxymaltose

Drug

Four intravenous dosages of ferric(III) carboxymaltose

Sodium Chloride

Drug

Four intravenous dosages of sodiumchloride

Other names: Placebo

Primary outcomes

  1. Exercise tolerance

    Time frame: 24 weeks

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

Secondary outcomes

  1. Hemoglobin level

    Time frame: 24 weeks

    The between-group difference in change in hemoglobin level

  2. Iron status

    Time frame: 24 weeks

    The between-group difference in change in iron parameters (plasma iron, ferritin, transferrin saturation)

  3. Cardiac function

    Time frame: 24 weeks

    The between-group difference in change in cardiac structure, function and strain, analysed with a transthoracic echocardiography

  4. Muscle strength 1

    Time frame: 24 weeks

    The between-group difference in change in muscle strength measured by the 'Five-Times-Sit-to-Stand-test (FTSTS)

  5. Muscle strength 2

    Time frame: 24 weeks

    The between-group difference in change in muscle strength measured by the timed-up-and-Go test (TUG)

  6. Muscle strength 3

    Time frame: 24 weeks

    The between-group difference in change in muscle strength measured by handgrip dynamometry

  7. Muscle mass

    Time frame: 24 weeks

    The between-group difference in change in muscle mass assessed using 24-hour urinary creatinine excretion

  8. Phosphate level

    Time frame: 24 weeks

    The between-group difference in change in phosphate level

  9. Calcium level

    Time frame: 24 weeks

    The between-group difference in change in calcium level

  10. Vitamin D status

    Time frame: 24 weeks

    The between-group difference in change in vitamin D level

  11. Parathyroid hormone

    Time frame: 24 weeks

    The between-group difference in change in parathyroid hormone level level

  12. FGF23

    Time frame: 24 weeks

    The between-group difference in change in FGF23 level

  13. Intestinal microbiota

    Time frame: 24 weeks

    The between-group difference in change in intestinal microbiota

  14. Incidence of any infection

    Time frame: 24 weeks

    The between-group difference in incidence of infections

  15. Incidence of hospitalisation

    Time frame: 24 weeks

    The between-group difference in incidence of hospitalisation

  16. Incidence of cardiac events

    Time frame: 24 weeks

    The between-group difference in incidence of cardiac events

  17. Incidence of graft failure

    Time frame: 24 weeks

    The between-group difference in incidence of graft failure

  18. Lymphocyte production of cytokines

    Time frame: 24 weeks

    The between-group difference in lymphocyte cytokine espression (measured with facs)

  19. Lymphocyte production of immunoglobulins

    Time frame: 24 weeks

    The between-group difference in lymphocyte IgG production (measured with ELISA)

  20. Lymphocyte proliferation rate

    Time frame: 24 weeks

    The between-group difference in lymphocyte proliferation rate (assessed with FACS)

  21. B-lymphocyte differentiation rate

    Time frame: 24 weeks

    The between-group difference in B-lymphocyte plasma cell formation (assessed with Facs)

  22. Cognitive performance (memory span)

    Time frame: 24 weeks

    The between-group difference in change in cognitive performance quantified with neuropsychological testing (Digit Span Forward Test, minimum value 0, maximum value 9, a higher score means a better outcome)

  23. Cognitive performance (verbal memory)

    Time frame: 24 weeks

    The between-group difference in change in cognitive performance quantified with neuropsychological testing (15 word test, minimum value 0, maximum value 75, a higher score means a better outcome)

  24. Cognitive performance (semantic memory)

    Time frame: 24 weeks

    The between-group difference in change in cognitive performance quantified with neuropsychological testing (Word Fluency Test, minimum value 0, no maximum value, a higher score means a better outcome)

  25. Cognitive performance (processing speed)

    Time frame: 24 weeks

    The between-group difference in change in cognitive performance quantified with neuropsychological testing (symbol digit modalities test, minimum value 0, maximum value 110, a higher score means a better outcome)

  26. Cognitive performance (visuomotor and mental speed)

    Time frame: 24 weeks

    The between-group difference in change in cognitive performance quantified with neuropsychological testing (Trail Making Test A, minimum value 1, no maximum value, a lower score means a better outcome)

  27. Cognitive performance (cognitive flexibility)

    Time frame: 24 weeks

    The between-group difference in change in cognitive performance quantified with neuropsychological testing (Trail Making Test B, minimum value 1, no maximum value, a lower score means a better outcome)

  28. Cognitive performance (executive control)

    Time frame: 24 weeks

    The between-group difference in change in cognitive performance quantified with neuropsychological testing (Controlled Oral Word Association Test, minimum score 1, no maximum score, a higher score means a better outcome)

  29. Cognitive performance (working memory)

    Time frame: 24 weeks

    The between-group difference in change in cognitive performance quantified with neuropsychological testing (Digit Span Backward, minimum score 0, maximum score 8, a higher score means a better outcome)

  30. Plasma creatinine

    Time frame: 24 weeks

    The between-group difference in change in plasma creatinine

  31. Quality of Life (health)

    Time frame: 24 weeks

    The between-group difference in change in quality of life quantified with SF36 questionnaire. A higher score means a better outcome.

  32. Quality of Life (subjective fatigue)

    Time frame: 24 weeks

    The between-group difference in change in quality of life quantified with the Dutch Checklist individual Strength). A higher score means worse fatigue.

  33. Quality of Life (long-lasting fatigue)

    Time frame: 24 weeks

    The between-group difference in change in quality of life quantified with the Dutch Multifactor Fatigue Scale). A higher score means worse fatigue.

  34. Quality of Life (overall)

    Time frame: 24 weeks

    The between-group difference in change in quality of life quantified with EuroQol-5D-5L

  35. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination IgG response

    Time frame: 12 months

    The between-group difference in severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) specific antibody titre after vaccination.

  36. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination T-lymphocyte response

    Time frame: 12 months

    The between-group difference in severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) specif T-lymphocyte response after vaccination.

  37. Gastro-intestinal symptoms

    Time frame: 24 weeks

    The between-group difference in change in gastro-intestinal symptoms assessed with the gastrointestinal symptom rating scale.

  38. Hepatic injury

    Time frame: 24 weeks

    The between-group difference in change in plasma hepatic enzyme levels (aspartate transaminase and alanine transaminase)

  39. Restless legs

    Time frame: 24 weeks

    The between-group difference in prevalence of restless legs symptoms before and after treatment

  40. Kidney graft rejection and injury

    Time frame: 24 weeks

    The between-group difference in change in urine kidney injury marker levels

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Dutch Kidney Foundation
  • Vifor Fresenius Medical Care Renal Pharma

Registry information

Official study title

Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation: a Multicenter Randomized Controlled Trial

Acronym: EFFECT-KTx

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 7, 2018
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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