Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation (EFFECT-KTx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03769441
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborators:
Dutch Kidney Foundation
Vifor Fresenius Medical Care Renal Pharma
Information provided by (Responsible Party):
Martin H. de Borst, University Medical Center Groningen

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.


Condition or disease Intervention/treatment Phase
Iron-deficiency Transplant-Related Disorder Drug: Ferric carboxymaltose Drug: Sodium chloride Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All participants, care providers and researchers will be blinded, except for the nurse who will administer the medication.
Primary Purpose: Treatment
Official Title: Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation: a Multicenter Randomized Controlled Trial
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: Ferric carboxymaltose
Four intravenous dosages of ferric(III) carboxymaltose

Placebo Comparator: Placebo
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
Four intravenous dosages of sodiumchloride
Other Name: Placebo




Primary Outcome Measures :
  1. Exercise tolerance [ Time Frame: 24 weeks ]
    The between-group difference in baseline-adjusted exercise tolerance quantified by the six-minute walk test (6MWT)


Secondary Outcome Measures :
  1. Hemoglobin level [ Time Frame: 24 weeks ]
    The between-group difference in baseline-adjusted hemoglobin level

  2. Iron status [ Time Frame: 24 weeks ]
    The between-group difference in baseline-adjusted severity of iron deficiency

  3. Cardiac function [ Time Frame: 24 weeks ]
    The between-group difference in baseline-adjusted cardiac function, analysed with a transthoracic echocardiography

  4. Muscle strength 1 [ Time Frame: 24 weeks ]
    The between-group difference in baseline-adjusted 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 baseline-adjusted muscle strength measured by the timed-up-and-Go test (TUG)

  6. Muscle strength 3 [ Time Frame: 24 weeks ]
    The between-group difference in baseline-adjusted muscle strength measured by handgrip dynamometry

  7. Phosphate level [ Time Frame: 24 weeks ]
    The between-group difference in baseline-adjusted phosphate level

  8. Calcium level [ Time Frame: 24 weeks ]
    The between-group difference in baseline-adjusted calcium level

  9. Vitamin D status [ Time Frame: 24 weeks ]
    The between-group difference in baseline-adjusted vitamin D level

  10. Parathyroid hormone [ Time Frame: 24 weeks ]
    The between-group difference in baseline-adjusted parathyroid hormone level level

  11. FGF23 [ Time Frame: 24 weeks ]
    The between-group difference in baseline-adjusted FGF23 level

  12. Intestinal microbiota [ Time Frame: 24 weeks ]
    Intestinal microbiota

  13. Incidence of any infection [ Time Frame: 24 weeks ]
    The between-group difference in incidence of infections

  14. Incidence of hospitalisation [ Time Frame: 24 weeks ]
    The between-group difference in incidence of hospitalisation

  15. Incidence of cardiac events [ Time Frame: 24 weeks ]
    The between-group difference in incidence of cardiac events

  16. Incidence of graft failure [ Time Frame: 24 weeks ]
    The between-group difference in incidence of graft failure

  17. Lymphocyte function [ Time Frame: 24 weeks ]
    The between-group difference in lymphocyte function

  18. Cognitive performance [ Time Frame: 24 weeks ]
    The between-group difference in baseline-adjusted cognitive performance quantified with neuropsychological testing

  19. Kidney function (eGFR) [ Time Frame: 24 weeks ]
    The between-group difference in baseline-adjusted estimated glomerular filtration rate

  20. Quality of Life (Short-Form 36) [ Time Frame: 24 weeks ]
    The between-group difference in baseline-adjusted quality of life quantified with SF36 questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 four months after transplantation at the time of inclusion (and six months after transplantation at baseline)
  • Age ≥18 years
  • Ability to comply with the study protocol
  • Informed consent

Exclusion Criteria:

  • Intolerance of any intravenous iron solution
  • Severe anemia (Hb <10.4 g/dL, <6.5 mmol/L), microcytic anemia or progressive anemia (˃1 mmol/L 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 g/dL, 9.3 mmol/L)
  • History of haemochromatosis
  • Resting heart rate of more than 120 per minute
  • 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
  • Severe hyponatremia (Na <130 mmol/L) or fluid overload
  • Participation in another interventional study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769441


Contacts
Layout table for location contacts
Contact: Anna-Sophie Vinke, MD 0031503611697 j.s.j.vinke@umcg.nl

Sponsors and Collaborators
University Medical Center Groningen
Dutch Kidney Foundation
Vifor Fresenius Medical Care Renal Pharma
Investigators
Layout table for investigator information
Principal Investigator: Martin de Borst, MD/PhD University Medical Center Groningen

Layout table for additonal information
Responsible Party: Martin H. de Borst, MD. PhD., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03769441     History of Changes
Other Study ID Numbers: 201800450
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Martin H. de Borst, University Medical Center Groningen:
Renal Transplantation
Kidney Transplantation
Iron Deficiency

Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics