Iron Deficiency Anemia Clinical Trial
Official title:
Intravenous Ferric Carboxymaltose (Ferinject®) With or Without Erythropoietin for the Correction of Preoperative Anaemia in Patients Undergoing Orthopaedic Surgery
Study Design: Single-centre, block randomised, blinded, controlled, phase IIIb, parallel
group pilot study.
Primary Objective:
• To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with or
without erythropoietin vs. no treatment (standard therapy) on the preoperative anaemia
status in patients undergoing orthopaedic surgery
Secondary Objective:
- To gain informations for the design of a possible follow-up study
- To evaluate the effect of the administration of ferric carboxymaltose (Ferinject®) with
or without erythropoietin vs. no treatment (standard therapy) on pre- and postoperative
Hb levels, iron status, transfusion rate, days until discharge.
- To evaluate the tolerability and safety of Ferinject®
Study Centres:
This is a single centre study
Patients:
A total of 75 completed patients (50 patients in the intravenous iron treatment groups and
25 patients in the no treatment group will be recruited.
TREATMENT:
Patients will be randomised 1:1:1 to one of the following groups:
Group I - Ferinject ® and EPO treatment group 25 patients will be randomised to the
Ferinject and EPO treatment group.
For each patient, the cumulative total iron requirement will be calculated using the formula
of Ganzoni [Ganzoni et al, 1970]:
Iron deficit [mg] = b.w. [kg]† x (target Hb - actual Hb) [g/L] x 0.24†† + depot iron [mg]
† In patients with a body mass index (BMI = weight [kg] / (height [m] x height [m])) >25, a
normalised weight will be used to calculate the iron deficit. Normalised weight [kg] = 25 x
height [m] x height [m].
†† Factor 0.24 = 0.0034 (iron content Hb = 0.34%) * 0.07 (blood volume = 7% of b.w.) * 1000
(conversion g to mg) Target Hb: 150 g/L Actual Hb: Value obtained at screening visit Depot
iron: 500 mg
Patients will receive a first dose of 1000 mg iron as Ferinject® 21 days prior to the
scheduled surgery. Patients will receive Ferinject® once weekly for up to two occasions (Day
-21 and Day -14) until the calculated cumulative dose is reached for that individual. The
Day -14 infusion may not be necessary, depending on the calculated total iron requirement
for each patient. Patients in treatment group 1 will get additionally a single 10000 IU dose
of EPO together on treatment day -14.
Group II - Ferinject ® treatment group 25 patients will be randomised to the Ferinject
without EPO.
For each patient, the cumulative total iron requirement will be calculated using the formula
of Ganzoni [Ganzoni et al, 1970]:
Iron deficit [mg] = b.w. [kg]† x (target Hb - actual Hb) [g/L] x 0.24†† + depot iron [mg]
† In patients with a body mass index (BMI = weight [kg] / (height [m] x height [m])) >25, a
normalised weight will be used to calculate the iron deficit. Normalised weight [kg] = 25 x
height [m] x height [m].
†† Factor 0.24 = 0.0034 (iron content Hb = 0.34%) * 0.07 (blood volume = 7% of b.w.) *1000
(conversion g to mg) Target Hb: 150 g/L Actual Hb: Value obtained at screening visit Depot
iron: 500 mg
Patients will receive a first dose of 1000 mg iron as Ferinject 21 days prior to the
scheduled surgery. Patients will receive Ferinject® once weekly for up to two occasions (Day
-21 and Day -14) until the calculated cumulative dose is reached for that individual. The
Day -14 infusion may not be necessary, depending on the calculated total iron requirement
for each patient.
Group III - Control group 25 patients will receive the standard treatment for this patient
population (no anaemia treatment).
Primary Efficacy Endpoints
• Hb increase from baseline till day of surgery
Secondary Efficacy Endpoints
- Percentage of patients reaching an Hb of > 12 g/dl (women) or of > 13 g/dl (men) at any
point in time during the study
- Change in Hb level from baseline to highest Hb level during the study
- Change in Ferritin value from baseline to highest ferritin value during the study
- Change in Tsat value from baseline to highest Tsat value during the study
- Transfusion rate
- Infection rate
- Days until discharge from hospital
- Days until rehabilitation therapy
Secondary Safety Endpoints:
- Adverse events: type, nature, incidence and outcome
- Vital signs (temperature, blood pressure and heart rate)
- Clinical laboratory panels (haematology/coagulation, clinical chemistry, except Hb and
iron status, which are considered to be efficacy endpoints)
Laboratory parameters:
Hematology/coagulation parameters to be analysed are Hb, haematocrit (Hct), red blood cell
count (RBC), white blood cell count (WBC) with differential and platelet count, mean
corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), mean corpuscular haemoglobin
concentration (MCHC).
Clinical chemistry parameters to be analysed are alkaline phosphatase (AP), gamma-glutamyl
transpeptidase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT),
C-reactive protein (CRP), endogenous erythropoietin.
Iron status parameters include serum iron, serum ferritin, serum transferrin and TSAT.
Additional parameters - folic acid, vitamin B12 and beta-HCG will be analysed at baseline
only, creatinin, soluble transferrin receptor and total bilirubin will be analysed at all
visits.
Statistical Methods:
Summary statistics will be provided for safety and efficacy parameters as well as for the
patients' demographic characteristics. Data will be presented per visit, if appropriate. The
test for the primary endpoint is confirmative. Statistical tests of secondary endpoints will
be employed for exploratory purposes to highlight interesting comparisons (e.g., baseline
versus end of study) that may warrant further consideration. Unless otherwise specified, the
significance level of all statistical tests will be 5% with a two-sided alternative. If
appropriate, corresponding 95%-confidence intervals will be calculated. The sample size
estimation is based on t-test calculation.
Continuous variables will be summarized as mean +/- SD and median with range where
appropriate. Continuous variables will be compared using the Kruskal-Wallis test followed by
pairwise Mann-Whitney tests with Bonferroni-correction. Nominal variables will be compared
using the chi-square test or Fisher's exact test where appropriate. Changes within groups of
nominal variables will be analyzed using McNemar test.
Changes within groups of continuous variables will be analyzed using the Friedman test
followed by pairwise post hoc comparisons using the Wilcoxon signed rank test with
Bonferroni correction. Prevalence of anaemia will be presented with exact confidence
interval (CI). Continuous variables will be transformed to normal distribution, and CIs for
the mean will be computed. The limits of these CIs then will be retransformed to the
original units and interpreted as CIs for the median.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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