Phase 3
Completed N=371
To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia
Source: ClinicalTrials.gov NCT03591406 ↗Enrolled (actual)
371
Serious AEs
4.6%
Results posted
May 2020
Primary outcomePrimary: Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8 — 176; 175 Participants
Summary
The primary objective is to demonstrate the efficacy of ferric carboxymaltose (FCM) given in a simple dosing regimen in correcting iron deficiency anaemia (IDA), by demonstrating non-inferiority to treatment with the currently approved intravenous (IV) iron therapy of iron sucrose (IS, Venofer™) in the Chinese population. The secondary objectives are to assess the safety of FCM compared to IS in the Chinese population and to evaluate the effect of FCM compared to IS on relevant laboratory parameters (haematology, chemistry, iron parameters) in the Chinese population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8 |
176; 175 | — |
| SECONDARY Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 |
150; 129; 164; 167; 169; 168 | — |
| SECONDARY Change in Hb From Baseline to Weeks 2, 4, 6, and 8 |
3.01; 2.53; 4.46; 4.08; 4.96; 4.61 | — |
| SECONDARY Participants With Iron Deficiency Correction Over Time by Treatment |
173; 135; 165; 168; 161; 163 | — |
| SECONDARY Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 |
30.16; 25.03; 28.00; 25.30; 25.50; 23.33 | — |
| SECONDARY Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 |
759.72; 385.51; 379.31; 280.58; 255.71; 184.93 | — |
| SECONDARY Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 |
15.53; 16.23; 12.31; 12.39; 10.77; 11.27 | — |
| SECONDARY Participants With Any Treatment Emergent Adverse Event (TEAE) |
124; 101 | — |
| SECONDARY Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 |
69.8; 71.9; 71.0; 72.6; 72.1; 73.8 | — |
| SECONDARY Body Weight at Baseline and Week 8 |
59.76; 60.40; 59.73; 60.64 | — |
| SECONDARY Heart Rate at Baseline and Weeks 2, 4, 6 and 8 |
81.4; 82.2; 76.3; 76.5; 75.5; 76.6 | — |
| SECONDARY Body Temperature at Baseline and Weeks 2, 4, 6 and 8 |
36.94; 36.45; 36.48; 36.44; 36.49; 36.40 | — |
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Hb 2 g/dL) in the 3 months post randomisation
- Subject has known malignancy (with or without current treatment), except basal cell or squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia
- Haemodialysis (current or planned within the next 3 months)
- History of IV iron therapy, erythropoiesis stimulating agent (ESA) therapy and/or blood transfusion in previous 4 weeks prior to screening, and oral iron or oral iron-containing products including Chinese herbal medicines (>75mg iron/day) in the 7 days prior to screening
- Body weight <35 kg
- Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above 3 times the upper limit of the normal range
- Known human immunodeficiency virus infection, acquired immunodeficiency syndrome, tuberculosis
- Known active hepatitis B or C or other active infection (acute or chronic)
- Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(ies), or subject is receiving other investigational agent(s)
- Subject is pregnant or is breast feeding
- Female subject of childbearing potential not using adequate contraceptive methods during the study and for up to 1 month after the last dose of the study medication. Adequate contraceptive methods are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. Non-childbearing potential includes being surgically sterilised at least 6 months prior to the study or post-menopausal, defined as amenorrhoea for at least 12 months
- Male subjects planning to father a child within 7 days from the last study drug administration.
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures and/or other reason(s) that render subject not appropriate for study participation in the opinion of the treating physician
Data sourced from ClinicalTrials.gov (NCT03591406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.