Iron Deficiency AnemiaPhase 4NCT00706667
Intravenous Ferric Carboxymaltose (Ferinject®) With or Without Erythropoietin in Patients Undergoing Orthopaedic Surgery
A Phase 4 study testing Ferinject ® in people with Iron Deficiency Anemia, run by University of Zurich at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferinject ®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2008to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age and signed written informed consent
- Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery)
- 10 g/dl < Hb < 13.0 g/dl for men and 10 g/dl < Hb < 12.0 g/dl for women, at screening ( 3 weeks prior to surgery)
- Ferritin < 100 μg/l or 100-300 with TSat < 20%
Who cannot join
- Suspicion of iron overload (Ferritin >300 μg/l or/and TSAT>50%)
- Active severe infection/inflammation (defined as serum CRP > 20 mg/l) or diagnosed malignancy
- Folate-and/or Vitamin B12 deficiency (according to local lab reference range)
- Known history of hepatitis B/C or HIV-positive
- Liver values 3 times higher than normal
- Immunosuppressive or myelosuppressive therapy
Show all 14Show fewer
- A concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients.
- Pregnancy or lactation
- Transfusion within 1 month prior to study inclusion, EPO treatment with in the last 4 weeks, any iron treatment within 4 weeks prior to the inclusion in the trail
- Participation in any other therapeutic trial within the previous month
- History of thromboembolic events in the family or the patient
- Severe peripheral, coronary or carotid artery disease
- Bodyweight < 50 kg
- Patients not able to understand the German language
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Anaesthesiology
Zurich, Canton of Zurich, 8091
About this study
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Ferinject ®
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferinject ®Drug
iv administration in Arm 1 placebo NaCl 0.9% In arm 2 iv administration of Ferinject ® and subcutaneous NaCl 0.9 % as an EPO placebo In arm 3 iv administration of Ferinject ® and subcutaneous EPO
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo for EPO and for Ferinject ® Receives: Drug: Ferinject ® |
| 2 | Active comparator | Only Ferinject ® , Placebo for EPO Receives: Drug: Ferinject ® |
| 3 | Active comparator | Ferinject ® + EPO Receives: Drug: Ferinject ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hb increase from baseline till day of surgery
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Not being able to recuit sufficient patients due to a lack of complience
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Responsible party
- Sponsor
- Investigators
- Oliver Theusinger, MD, Principal investigator, University Hospital Zurich, Division of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706667
- Sponsor's protocol ID
- StV 07-2008
- Status last verified
- Jun 2013
- First submitted
- 25 Jun 2008
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Ferric Carboxymaltose (Ferinject®) With or Without Erythropoietin for the Correction of Preoperative Anaemia in Patients Undergoing Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT00706667
- Acronym / sponsor ID
- StV 07-2008
- Conditions
- Iron Deficiency Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not being able to recuit sufficient patients due to a lack of complience
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Vifor Pharma
- Study start
- May 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Ferinject ®Placebo for EPO and for Ferinject ® |
| 2 | Active comparator | Drug: Ferinject ®Only Ferinject ® , Placebo for EPO |
| 3 | Active comparator | Drug: Ferinject ®Ferinject ® + EPO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years of age and signed written informed consent
- Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery)
- 10 g/dl < Hb < 13.0 g/dl for men and 10 g/dl < Hb < 12.0 g/dl for women, at screening ( 3 weeks prior to surgery)
- Ferritin < 100 μg/l or 100-300 with TSat < 20%
Key exclusion criteria (14 listed)
- Suspicion of iron overload (Ferritin >300 μg/l or/and TSAT>50%)
- Active severe infection/inflammation (defined as serum CRP > 20 mg/l) or diagnosed malignancy
- Folate-and/or Vitamin B12 deficiency (according to local lab reference range)
- Known history of hepatitis B/C or HIV-positive
- Liver values 3 times higher than normal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferinject ®iv administration in Arm 1 placebo NaCl 0.9% In arm 2 iv administration of Ferinject ® and subcutaneous NaCl 0.9 % as an EPO placebo In arm 3 iv administration of Ferinject ® and subcutaneous EPO | Drug | 1, 2, 3 |
Primary outcome
Hb increase from baseline till day of surgery
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Not being able to recuit sufficient patients due to a lack of complience). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
Related trials for Iron Deficiency Anemia
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Theusinger, MD principal investigator
University Hospital Zurich, Division of Anaesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferinject ® in people with Iron Deficiency Anemia, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Not being able to recuit sufficient patients due to a lack of complience). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hb increase from baseline till day of surgery (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.