To study the effects of FCM on exercise tolerance, haematinic parameters, quality of life, cardiac function, muscle function, bone and mineral parameters, microbiota, the immune system, the incidence of infections, allograft failure and mortality in…
ID
Source
Brief title
Condition
- Heart failures
- Iron and trace metal metabolism disorders
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is change in six-minute-walking test score.
Secondary outcome
Secondary parameters are haematinic parameters, quality of life, cardiac
function, muscle function, bone and mineral parameters, microbiota, the immune
system, the incidence of infections, allograft failure and mortality in
iron-deficient kidney transplant recipients (KTRs).
In a subgroup of participants the antibody and lymphocyte response after
vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)
will also be assessed as a secundary endpoint.
We will also assess the in vitro effect of iron deficiency induced by
deferoxamine on lymphocyte proliferation, differentiation and cytokine and IgG
production.
Background summary
Iron deficiency is a common phenomenon in kidney transplant recipients and is
associated with unfavourable prognosis and impaired exercise tolerance. We
hypothesize a beneficiary effect of Ferric Carboxymaltose (FCM) on exercise
tolerance and quality of life.
Study objective
To study the effects of FCM on exercise tolerance, haematinic parameters,
quality of life, cardiac function, muscle function, bone and mineral
parameters, microbiota, the immune system, the incidence of infections,
allograft failure and mortality in iron-deficient kidney transplant recipients
(KTR*s).
Also, the in vitro effect of iron deficiency on lymphocyte growth and function
wil be studied to support possible results of the intervention study.
Study design
We will perform a Randomised Controlled Clinical Trial to compare Ferric
Carboxymaltose with a placebo.
We will also perform a pilot in vitro study using blood from healthy subjects.
Blood products will be treated with iron chelating agent deferoxamine after
blood withdrawal.
Intervention
The intervention group will receive 500mg of FCM every six weeks, with a total
of four dosages. The other group receives an intravenous placebo solution. No
intervention will be performed in healthy volunteers.
Study burden and risks
Treatment of iron-deficient KTR*s with FCM contains some risks. Mild adverse
effects may occur and severe reactions, which are extremely rare, cannot be
excluded. The long term effects of FCM-induced hypophosphatemia on the bone
density are unknown. FCM has been thoroughly studied and is frequently used in
various populations. It has proved to be a safe and highly effective medicine
to treat iron deficiency.
Burden and risks for helathy volunteers are minimal. A blood collection may
cause mild pain.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-002571-18-NL |
| ClinicalTrials.gov | NCT03769441 |
| CCMO | NL67065.042.18 |