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Trial record 45 of 380 for:    FERRIC CATION

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

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ClinicalTrials.gov Identifier: NCT03591406
Recruitment Status : Completed
First Posted : July 19, 2018
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
Tigermed Consulting Co., Ltd
Information provided by (Responsible Party):
Vifor Inc.

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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Ferric carboxymaltose Drug: Iron sucrose Phase 3

Detailed Description:

This is an open-label, randomised controlled study to assess the impact of FCM in correcting iron deficiency anaemia compared with Venofer™ (IS).

All subjects, after providing written informed consent and meeting the eligibility assessments, will receive a first dose of IV iron as either FCM or IS. A total of approximately 368 subjects (184 per group) will be enrolled. All subjects will have iron deficiency anaemia as measured by haemoglobin (Hb), serum ferritin and transferrin saturation (TSAT) at screening.

Ferric carboxymaltose will be administered as either a diluted infusion or undiluted injection (at Investigator discretion) and IS will be administered as a slow intravenous injection at a rate of 1 ml undiluted solution per minute (with each single injection of 200 mg iron) or by drip infusion. Note, for subjects randomised to receive IS dosing visits are required three times a week to achieve total iron repletion dosing as calculated using the Ganzoni formula.

For subjects randomised to FCM, the total iron requirements will be calculated at screening based on the screening Hb and subject weight. Dosing will be at baseline and, if required, at day 8 and day 15. All subjects will attend study visits at screening, baseline and thereafter at Weeks 2, 4 and 6. All subjects will attend an end of study visit (at Week 8 - or earlier if discontinued prematurely).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label, parallel design, randomised controlled multi-centre trial in Chinese subjects
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomised Controlled Multi-centre Study to Assess the Impact of Ferric Carboxymaltose in Correcting Iron Deficiency Anaemia Compared With Venofer® (Iron Sucrose) in Chinese Subjects
Actual Study Start Date : July 3, 2017
Actual Primary Completion Date : February 25, 2019
Actual Study Completion Date : February 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Ferric carboxymaltose (FCM)
Subjects treated with FCM given by IV injection or drip infusion
Drug: Ferric carboxymaltose
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.
Other Name: FCM

Active Comparator: Iron sucrose (IS)
Subjects treated with IS given by IV injection or drip infusion
Drug: Iron sucrose
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.
Other Names:
  • IS
  • Venofer™




Primary Outcome Measures :
  1. Haemoglobin (Hb) g/dL [ Time Frame: From baseline at any time up to Week 8 ]
    Percentage of subjects achieving an increase in Hb of > or equal to 2 g/dL at any time up to week 8


Secondary Outcome Measures :
  1. Haemoglobin (Hb) g/dL [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]
    Percentage of subjects achieving an increase in Hb > or equal to 2 g/dL from baseline and week 2, 4, 6 and 8

  2. Change in Hb g/dL from baseline [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]
    To weeks 2, 4, 6 and 8

  3. Percentage of subjects with TSAT ≥16% and serum ferritin ≥100 ng/mL [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]
    The percentage of subjects with TSAT≥16% and serum ferritin ≥100 ng/mL (for subjects with underlying inflammatory disease as determined by hsCRP levels above the normal range) or > 14ng/mL (in subjects with no apparent underlying inflammatory disease as determined by hsCRP levels within normal range at screening) at week 2, 4, 6 and 8

  4. TSAT (%) [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]
    Change in TSAT from baseline to weeks 2, 4, 6 and 8

  5. Serum ferritin (ng/mL) [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]
    Change in serum ferritin from baseline to Weeks 2, 4, 6 and 8

  6. Serum iron (mcg/dL) [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]
    Change in serum iron from baseline to Weeks 2, 4, 6 and 8

  7. Treatment emergent adverse events (TEAE): [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]
    Reported TEAEs

  8. Blood pressure (BP, mm hg) [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]
    BP at baseline and weeks 2, 4, 6 and 8

  9. Body weight (BW) [ Time Frame: Baseline and week 8 ]
    BW

  10. Heart rate (beats per minute) [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]
    Heart rate

  11. Temperature (°C) [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]
    Body temperature



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591406


Locations
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China, Zhejiang
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Vifor Inc.
Tigermed Consulting Co., Ltd
Investigators
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Principal Investigator: Jie Jin The First Affiliated Hospital, Zhejiang University

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Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT03591406     History of Changes
Other Study ID Numbers: VIT-IRON-2011-004
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ferric Compounds
Ferric Oxide, Saccharated
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics