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Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation

NCT03769441 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2024-08-27

No results posted yet for this study

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

Interventions

DRUG

Ferric carboxymaltose

Four intravenous dosages of ferric(III) carboxymaltose

DRUG

Sodium chloride

Four intravenous dosages of sodiumchloride

Sponsors & Collaborators

  • Dutch Kidney Foundation

    collaborator OTHER

  • Vifor Fresenius Medical Care Renal Pharma

    collaborator INDUSTRY

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Martin de Borst, MD/PhD · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-02
Primary Completion
2024-08-19
Completion
2024-08-19

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03769441 on ClinicalTrials.gov