To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia

NCT03591406 | Completed Phase 3 Results

• 1 other identifier: VIT-IRON-2011-004
• Study Type: interventional
• Target: 371
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8

  Haemoglobin (Hb)

  From baseline at any time up to Week 8

Secondary Outcomes (11)

• Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8

  From Baseline to weeks 2, 4, 6 and 8

• Change in Hb From Baseline to Weeks 2, 4, 6, and 8

  From Baseline to weeks 2, 4, 6 and 8

• Participants With Iron Deficiency Correction Over Time by Treatment

  From Baseline to Weeks 2, 4, 6 and 8

• Change in TSAT From Baseline to Weeks 2, 4, 6 and 8

  From Baseline to weeks 2, 4, 6 and 8

• Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8

  From Baseline to Weeks 2, 4, 6 and 8

Study Arms (2)

Ferric carboxymaltose (FCM)

EXPERIMENTAL

Subjects treated with FCM given by IV injection or drip infusion

Drug: Ferric carboxymaltose

Iron sucrose (IS)

ACTIVE COMPARATOR

Subjects treated with IS given by IV injection or drip infusion

Drug: Iron sucrose

Interventions

Ferric carboxymaltose DRUG

Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.

Also known as: FCM

Ferric carboxymaltose (FCM)

Iron sucrose DRUG

Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.

Also known as: IS, Venofer™

Iron sucrose (IS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Hb \<11 g/dL (females) or Hb \<12 g/dL (males) at the screening visit
• Serum ferritin \<100 ng/mL for subjects with underlying inflammatory disease (e.g., inflammatory bowel disease (IBD), chronic kidney disease (CKD) or chronic heart failure (CHF), as determined by high sensitive C-reactive protein \[hsCRP\] levels above the normal range) otherwise ≤14 ng/mL in subjects with no apparent underlying inflammatory disease (as determined by hsCRP levels within normal range) at the screening visit
• Transferrin Saturation (TSAT) \<16% (any subject) at the screening visit
• Microcytic, hypochromic anaemia defined as: a) Mean corpuscular Hb concentration (MCHC) \<32%; b) Mean corpuscular volume (MCV) \< 80 fL; c)Mean corpuscular Hb (MCH) \<27 pg
• Subjects with the ability to understand the requirements of the study and abide by the study restrictions, and who agree to return for the required assessments
• Before any study-specific procedure is conducted, the appropriate written informed consent must be obtained

You may not qualify if:

• Subject has known hypersensitivity to any of the products to be administered during dosing
• Any history of iron storage diseases such as haemochromatosis
• Any history or clinical findings of iron utilisation disorders such as sideroachrestic anaemia
• Known haemoglobinopathy (e.g. thalassaemia)
• Any history or clinical findings of anaemia associated with: a) Haematuria b) Vitamin B12 or folic acid deficiency that requires treatment (subjects can be included after deficiency is corrected)
• Any allergic predispositions, i.e. any history of asthma or atopic allergy. This includes drug allergies.
• Planned surgery with anticipated blood loss (defined as Hb drop \>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)

Sponsors & Collaborators

• Vifor (International) Inc.: lead
• Tigermed Consulting Co., Ltd: collaborator

Study Sites (1)

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: VIT-IRON-2011-004 Clinical Study Team
• Organization: Vifor (International) Inc.

VIT-IRON-2011-004.study@viforpharma.com

+41 58 851 80 00

Study Officials

• Jie Jin

  The First Affiliated Hospital, Zhejiang University

  PRINCIPAL INVESTIGATOR

• Zhihua Ran

  Renji Hospital Shanghai Jiaotong Uniersity School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, parallel design, randomised controlled multi-centre trial in Chinese subjects

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 19, 2018
• Study Start: July 3, 2017
• Primary Completion: February 25, 2019
• Study Completion: February 25, 2019
• Last Updated: June 10, 2021
• Results First Posted: May 18, 2020

Record last verified: 2021-05

Locations

CN (1)