Ferric Carboxymaltose Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent CKD (FIND-CKD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Luitpold Pharmaceuticals
ICON Clinical Research
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT00994318
First received: October 12, 2009
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

Phase IIIb (1016 pts, 19 countries) study to evaluate the long-term efficacy of FCM (using targeted ferritin levels to determine dosing) or oral iron in NDD-CKD subjects with iron deficiency anaemia (IDA).


Condition Intervention Phase
Iron Deficiency Anemia
Chronic Kidney Disease
Drug: Ferinject
Drug: Oral Iron
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of IV Ferric Carboxymaltose Versus Oral Iron for Treatment of Iron Deficiency Anaemia in Subjects With Non-dialysis-dependent CKD

Resource links provided by NLM:


Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • Time to the initiation of other anaemia management (e.g., ESA or transfusion) using Kaplan-Meier survival analyses. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1016
Study Start Date: December 2009
Estimated Study Completion Date: December 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferinject (1000mg iron) Drug: Ferinject
Ferinject
Other Name: Ferric Carboxymaltose
Experimental: Ferinject (200mg Iron) Drug: Ferinject
Ferinject
Other Name: Ferric Carboxymaltose
Active Comparator: Oral Iron (200mg elemental iron) Drug: Oral Iron
Oral Iron 200mg
Other Name: Iron (II) sulphate

Detailed Description:

Open-label, multicentre, randomised, 3-arm design study to assess the use of FCM (using targeted ferritin levels to determine dosing) or oral iron to delay and/or reduce ESA use in NDD-CKD subjects with IDA.

Post an initial screening period (up to 4 weeks) eligible subjects will be randomised (1:1:2) to 1 of the following 3 treatment arms for a period of 52 weeks.

  1. High dosage (1,000 mg of iron) regimen of intravenous FCM targeting a ferritin level of 400-600 mcg/L.
  2. Low dosage (200 mg of iron) regimen of intravenous FCM targeting a ferritin level of 100-200 mcg/L.
  3. Daily oral iron (180-200 mg elemental iron).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. NDD-CKD subjects with an eGFR ≤60ml/min/1.73m2 using MDRD calculation
  2. NDD-CKD subjects with an eGFR loss ≤12ml/min/1.73m2 per year (based on at least 2 values over at least 4 weeks prior to randomisation ideally 3 values over at least 3 months) and a predicted eGFR ≥15ml/min/1.73m2 in 1 year. If more than 3 eGFR values are available in the 2-year time period prior to randomisation, the predicted loss should be calculated using 3 appropriately representative values. If predicted eGFR decline ≤12ml/min/1.73m2 per year then subject may be included
  3. Hb between 9 and 11g/dL within 4 weeks of randomisation. Note A value taken as part of routine medical may be used
  4. Serum ferritin <100mcg/L or <200mcg/L with TSAT <20% within 4 weeks of randomisation. Note Measurements taken as part of routine medical care may be used
  5. ESA naïve (no exposure 4 months prior to randomisation)
  6. Females of childbearing potential must have a negative pregnancy test prior to randomisation
  7. Before any study-specific procedure the appropriate written informed consent must be obtained

Exclusion Criteria:

  1. History of acquired iron overload
  2. Known hypersensitivity reaction to any component of ferrous sulphate or FCM. Note subjects with hypersensitivity to other forms of iron will be permitted to participate
  3. Documented history of discontinuing oral iron products due to significant GI distress
  4. Screening TSAT >40%
  5. Known active infection, C-reactive protein >20mg/L, clinically significant overt bleeding, active malignancy
  6. History of chronic alcohol abuse (alcohol consumption >40g/day)
  7. Chronic liver disease and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range
  8. Active human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B or C virus infection
  9. Anaemia due to reasons other than iron deficiency. Subjects with treated Vitamin B12 or folic acid deficiency are permitted
  10. IV iron and/or blood transfusion in previous 30 days prior to screening
  11. Oral iron therapy at doses >100mg/day in previous 1 week prior to randomisation and/or patients who have been continuously treated with >100mg/day of oral iron for the last 3 months. Upon randomisation the oral iron therapy must be discontinued. Note Ongoing use of multivitamins containing iron are permitted
  12. Immunosuppressive therapy that may lead to anaemia. Note Steroid therapy is permitted
  13. Currently requiring renal dialysis
  14. Anticipated dialysis or transplant during the study
  15. Anticipated need for surgery that may result in significant bleeding (>100ml)
  16. Currently suffering from chronic heart failure NYHA Class IV
  17. >160mmHg systolic pressure or >100mmHg diastolic pressure
  18. Acute coronary syndrome or stroke within the 3 months prior to screening
  19. Currently suffering from concomitant severe psychiatric disorders or other conditions which in the opinion of the Investigator make participation unacceptable
  20. Subject is not using adequate contraceptive precautions. Adequate contraceptive precautions are defined as those which result in a low failure rate 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 postmenopausal defined as amenorrhea for at least 1 year
  21. Subject of childbearing potential is evidently pregnant or is breastfeeding
  22. Body weight <35kg
  23. Subject currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug studies or subject receiving other investigational agents
  24. Subject will not be available for follow up assessment
  25. Subject has any kind of disorder that compromises the ability to give written informed consent and/or comply with study procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994318

  Show 21 Study Locations
Sponsors and Collaborators
Vifor Inc.
Luitpold Pharmaceuticals
ICON Clinical Research
Investigators
Principal Investigator: Iain Macdougall King's College Hospital NHS Trust
  More Information

No publications provided

Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT00994318     History of Changes
Other Study ID Numbers: FER-CKD 01
Study First Received: October 12, 2009
Last Updated: March 11, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health and Welfare
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: National Health Service
United States: Food and Drug Administration

Keywords provided by Vifor Inc.:
Ferinject Iron Deficiency Anaemia Chronic Kidney Disease

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Deficiency Diseases
Anemia, Iron-Deficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Iron
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014