A Phase 4 interventional study of Ferinject and Ferrous Sulfate 200 MG in Iron Deficiency Anemia, sponsored by Liverpool Hope University. Not yet recruiting. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-02-01.
Sponsored by Liverpool Hope University · Phase 4, Interventional, and Basic science
Among 57 studies testing ferric carboxymaltose in Anemia, Iron-Deficiency — 7 open to participants now, 7 under way, none of them phase 3. ferric carboxymaltose · Anemia, Iron-Deficiency.
Among the 57 studies testing ferric carboxymaltose in Anemia, Iron-Deficiency, this one is the 28th largest by planned enrollment, is one of 2 that started in 2023, is one of 24 in phase 4, and was the 49th registered.
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
Browse Anemia, Iron-Deficiency studies →7 of the 57 studies testing ferric carboxymaltose in Anemia, Iron-Deficiency are open now, in 1 country. Recruiting first, the newest first:
Western Galilee Hospital-Nahariya · Sites in Israel
Hawler Medical University
Zhaojian Niu,MD
Children's Hospital of Orange County
Hospital de Santa Cruz, Portugal
By country, each count listing its studies:
ferric carboxymaltose: first FDA approval 2013 (INJECTAFER). What it is approved for, and how studies give it, is on its page →
Of the 54 Anemia, Iron-Deficiency studies recruiting now, 19 (35%) set no upper age limit and 31 (57%) stop at 75 or younger; 15 take children under 18; 17 take healthy volunteers.
This study: 60 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
57 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 9 · Phase 3 17 · Phase 4 24
First in 2006; this study’s year is marked. 2 started in 2023.
This study's planned enrollment of 100 is close to the median of 100 across 459 interventional studies indexed under Anemia, Iron-Deficiency.
Median enrollment 100 across the 57 interventional studies. Of the 45 that completed or were terminated, 15 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 57 have an industry lead sponsor. The 10 most frequent:
Liverpool Hope University is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Liverpool Hope University has 1 study filed under Anemia, Iron-Deficiency — fewer than ten, so there is no comparison to draw.
2 of the studies testing ferric carboxymaltose in Anemia, Iron-Deficiency that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06061393Western Galilee Hospital-NahariyaComparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia | 2027-09 |
| NCT07772453Zhaojian Niu,MDFerric Carboxymaltose Versus Iron Sucrose for Iron Deficiency Anemia After Radical Gastrectomy for Gastric Cancer | 2027-11 |
Among the 57 studies testing ferric carboxymaltose in Anemia, Iron-Deficiency, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Anaemia is a risk factor for functional decline and frailty in older adults including decreased physical performance and muscle strength, increased hospitalisation risk and mortality, falls, and poorer recovery from activities of daily living. Despite a major gap in human studies, research in animals has demonstrated an interrelationship between iron deficiency anaemia and deteriorated functional capacity and physical performance particularly in older adults. Iron deficiency and associated anaemia is a frequent accompanier of debilitating chronic diseases such as heart failure and chronic lung diseases. These conditions, more commonly seen in older patients, are strongly linked to deterioration in physical function, reduced skeletal muscle mass and quality, frailty, and poor quality of life. Exercise intolerance is also a common feature of these conditions as iron deficiency impairs the capacity of carrying oxygen leading to inability to sustain physical activities. Furthermore, the age-related decline in the muscle mass and quality (so called sarcopenia) and associated frailty has rapidly become a major health concern in the older adults particularly when accompanied by other chronic diseases. Recently, there has been an increasing interest in exploring the role of iron as a causative factor in the development of sarcopenia and related frailty.
In summary, there is a substantial gap of evidence whether Iron repletion leads to meaningful enhancements in the skeletal muscle function and physical performance in older adults suffering from iron deficiency anaemia. This study will investigate the impact of a standard care intervention (intravenous iron therapy) on muscular function and physical performance in older patients through a range of laboratory assessments.
The study will recruit two groups of stable patients (although likely with chronic diseases) with established iron deficiency anaemia through Aintree Hospital NHS Trust clinics. Fifty patients aged 60-85 years will be recruited into each group:
Identified patients with iron deficiency anaemia will receive an invitation to participate in the study together with a Patient Information Sheet clearly explaining different aspects of the research project. Each participant will require to attend the School of Health Sciences' laboratories (Liverpool Hope University) on four different occasions (once before the intervention and three times after receiving the iron therapy) throughout a 3-year period to complete multiple assessments in relation to basic blood tests and musculoskeletal function and physical performance. In addition to this, participants in the first group will require to attend the Aintree Hospital NHS Trust clinics on one occasion to receive a single-dose intravenous iron.
The study will broadly investigate musculoskeletal function (health) and physical performance by means of muscle quality, muscle mass, muscle strength, muscle activation and fatigue levels, gait quality, muscle physiology (level of oxygen carried into the muscles), and functional questionnaires prior to, during, and after iron therapy. In addition to this, changes in patients' quality of life in each group will be assessed through administration of validated questionnaires.
The data will be analysed at the end of the study to identify any significant and clinically meaningful changes in the musculoskeletal function, physical performance, and health-related quality of life resulted from the iron therapy in each group while also comparing such changes between the two study groups.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will receive intravenous iron calculated based on body weight and level of anaemia (hemoglobin concentration), as per the iron therapy's SPC.
Drug: Ferinject
This group will receive oral ferrous sulphate prescribed by their GP Randmisation: Simple randomisation/parallel assignment/single-blinded
Drug: Ferrous Sulfate 200 MG
Ferinject Therapy Group: each patient's Iron need for repletion by the Ferinject will be determined using product SPC dosing based on patient's body weight and Hb level. Accordingly, the appropriate dose of Ferinject will be administered while ensuring that a single administration will not exceed: * 15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion) * 1,000 mg of iron (20 mL Ferinject) The cumulative dose of Ferinject per week will not exceed 1,000 mg of iron (20 mL Ferinject).
Also known as: ferric carboxymaltose
Active Control Group (standard care excl. IV Iron): Oral Ferrous sulphate 200 mg three times daily.
Also known as: oral iron
Muscle Quality Index (MQI)
Muscle strength relative to volume of the muscle mass generating the force
Time frame: "through study completion, an average of 2 year"
Health-history Questionnaire
Questionnaire to document participant health history
Time frame: Baseline
International Physical Activity Questionnaire-IPAQ)
Questionnaire to determine the level of physical activity
Time frame: Baseline
Blood Iron Profile
Blood analysis including Hemoglobin, Iron, Ferritin, and Transferrin
Time frame: "Through study completion, an average of 2 year"
Upper Extremity Strength (in Newtons)
Dynamometry to measure upper extremity (Grip and shoulder forward flexion) strength
Time frame: "Through study completion, an average of 2 year"
Lower Extremity Muscle Strength (in Newtons)
Dynamometry to measure lower extremity (Knee extension) strength
Time frame: "Through study completion, an average of 2 year"
Skeletal Muscle Mass (kg)
Bio-Impedance (BIA) to measure the skeletal muscle mass (kg)
Time frame: "Through study completion, an average of 2 year"
Muscle Fatigue
Electromyographic (EMG) assessment of localised muscle fatigue
Time frame: "Through study completion, an average of 2 year"
Muscle Activation
Electromyographic (EMG) assessment of muscle activity level
Time frame: "through study completion, an average of 2 year"
Gait Analysis
3-Dimensional Motion Capture to assess gait quality
Time frame: "Through study completion, an average of 2 year"
Short Battery of Physical Performance (SBPP)
A validated test for assessing physcial and functional capacity
Time frame: "through study completion, an average of 2 year"
Mitochondrial Function
Near-infrared spectroscopy (NIRS) to investigate quality of oxidation in muscles
Time frame: "through study completion, an average of 2 year"
The 12-Item Short Form Health Survey (SF-12)
A patient-rated questionnaire to assess the Quality of Life
Time frame: "Through study completion, an average of 2 year"
The Hospital Anxiety and Depression Scale (HADS)
A patient-rated questionnaire to assess anxiety and Depression
Time frame: "Through study completion, an average of 2 year"
The Sarcopenia Quality of Life (SarQoL)
A patient-rated questionnaire to assess Sarcopenia-specific quality of life
Time frame: "through study completion, an average of 2 year"
The Upper Extremity Functional Index (UEFI)
A patient-rated questionnaire to assess Upper Extremity Function
Time frame: "through study completion, an average of 2 year"
The Lower Extremity Functional Index (UEFI)
A patient-rated questionnaire to assess Lower Extremity Function
Time frame: "through study completion, an average of 2 year"
No study locations are listed for this record.
Plan to share: Undecided — NK
Start is estimated for Jan 2023; primary completion for Aug 2026, 43 months later.
Of 43 non-industry phase 4 interventional studies under Anemia, Iron-Deficiency, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 35. This study's planned 43 months is above that.
Counting every sponsor, half of 51 studies reached it within 22 months; a quarter within 15 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ferric carboxymaltose
Liverpool Hope University