EFFECT OF FERRIC CARBOXYMALTOSE ON EXERCISE CAPACITY AFTER KIDNEY TRANSPLANTATION: A MULTICENTER RANDOMIZED CONTROLLED TRIA

Phase 4

Completed

Conditions: Iron deficiency after renal Transplantation
Iron shortage after kidney transplantation
10019280
10022958
10038430

Registration Number: NL-OMON52637

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 158

Inclusion Criteria

1. Kidney transplant recipients
2. Iron deficiency, defined by a ferritin level of <=100 ug/L, or 100-299 ug/L
combined with a transferrin saturation of <=20%
3. At least four months after transplantation at the time of inclusion (or: six
months after transplantation at baseline)
4. Age more than 18 years
5. Ability to comply with the study protocol
6. Informed consent

Exclusion Criteria

1. Intolerance of any intravenous iron solution
2. Severe (Hb <10.4 g/dL, <6.5 mmol/L), microcytic or progressive anemia
3. A positive feces occult blood test or known source of gastrointestinal blood
loss after endoscopy
4. Blood transfusion in the past six weeks
5. Polycythemia (Hb >15.3 g/dL, 9.5 mmol/L)
6. Haemochromatosis
7. An estimated glomerular filtration rate (eGFR) of <= 30 ml/min per 1.73
m2 at screening
8. Resting heart rate of more than 120 per minute
9. Unstable angina or myocardial infarction during the previous month
10. Disability to walk
11. Hypophosphatemia (serum phosphate <0.35 mmol/L)
12. Pregnancy
13. Severe hyponatremia (Na <130 mmol/L) or fluid retention
14. Participation in another interventional trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is change in six-minute-walking test score. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are haematinic parameters, quality of life, cardiac<br /><br>function, muscle function, bone and mineral parameters, microbiota, the immune<br /><br>system, the incidence of infections, allograft failure and mortality in<br /><br>iron-deficient kidney transplant recipients (KTRs).<br /><br>In a subgroup of participants the antibody and lymphocyte response after<br /><br>vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)<br /><br>will also be assessed as a secundary endpoint.<br /><br>We will also assess the in vitro effect of iron deficiency induced by<br /><br>deferoxamine on lymphocyte proliferation, differentiation and cytokine and IgG<br /><br>production. </p><br>