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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00994318




Registration number
NCT00994318
Ethics application status
Date submitted
12/10/2009
Date registered
14/10/2009
Date last updated
20/05/2014

Titles & IDs
Public title
Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
Scientific title
An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject High and Low Dosage Regimens) Versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease
Secondary ID [1] 0 0
FER-CKD-01
Universal Trial Number (UTN)
Trial acronym
FIND-CKD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron Deficiency Anaemia 0 0
Chronic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Blood 0 0 0 0
Anaemia
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FCM (Ferric carboxymaltose) high ferritin target
Treatment: Drugs - FCM (Ferric carboxymaltose) low ferritin target
Treatment: Drugs - Oral Iron (Ferrous sulphate)

Experimental: FCM (high ferritin target) - Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L

Experimental: FCM (low ferritin target) - Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L

Active Comparator: Oral Iron - Ferrous sulphate 100 mg iron twice daily, continuous


Treatment: Drugs: FCM (Ferric carboxymaltose) high ferritin target


Treatment: Drugs: FCM (Ferric carboxymaltose) low ferritin target


Treatment: Drugs: Oral Iron (Ferrous sulphate)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kaplan-Meier Survival Analysis for Time to Other Anemia Therapy or Hb Trigger
Timepoint [1] 0 0
Up to 1 year after baseline

Eligibility
Key inclusion criteria
1. At least 18 years of age.

2. NDD-CKD subjects with an estimated glomerular filtration rate (eGFR) =60 mL/min/1.73
m2 using modification of diet in renal disease 4 (MDRD-4) calculation.

3. NDD-CKD subjects with an eGFR loss =12 mL/min/1.73 m2/year and a predicted eGFR of =15
mL/min/1.73 m2 in 12 months.

4. Any single Hb between 9 and 11 g/dL within 4 weeks of randomisation. A value taken as
part of routine medical care was used.

5. Any single serum ferritin <100 mcg/L or <200 mcg/L with TSAT <20% within 4 weeks of
randomisation. Measurements taken as part of routine medical care were used.

6. ESA naïve; no exposure to ESA in last 4 months prior to randomisation.

7. Females of childbearing potential must have had a negative pregnancy test, using any
medically acceptable assessment, prior to randomisation.

8. Before any study specific procedure, the appropriate written informed consent must
have been obtained.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of acquired iron overload.

2. Known hypersensitivity reaction to any component of ferrous sulphate or FCM. Subjects
with hypersensitivity to other forms of iron were permitted to participate.

3. Documented history of discontinuing oral iron products due to significant
gastrointestinal (GI) distress.

4. Screening TSAT >40%.

5. Known active infection, C-reactive protein >20 mg/L, clinically significant overt
bleeding, active malignancy (i.e., clinical evidence of current malignancy or not in
stable remission for at least 5 years since completion of last treatment with
exception of basal cell or squamous cell carcinoma of the skin, and cervical
intraepithelial neoplasia).

6. History of chronic alcohol abuse (alcohol consumption >40 g/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 (HIV)/acquired immunodeficiency syndrome or active
hepatitis B or C virus infection.

9. Anaemia due to reasons other than iron deficiency (e.g., haemoglobinopathy). Subjects
with treated Vitamin B12 or folic acid deficiency were permitted.

10. IV iron and/or blood transfusion in previous 30 days prior to screening (or during the
screening period).

11. Oral iron therapy at doses >100 mg/day dosing must have been discontinued at least 1
week prior to randomisation. If subject had received this therapy for >3 months (at
doses >100 mg/day) then subject was not eligible. Ongoing use of multivitamins
containing iron was permitted.

12. Immunosuppressive therapy that may have led to anaemia (e.g., cyclophosphamide,
azathioprine, or mycophenolate mofetil). Steroid therapy was permitted.

13. Currently requiring renal dialysis.

14. Anticipated dialysis or transplant during the study.

15. Anticipated need for surgery that may have resulted in significant bleeding (>100 mL).

16. Currently suffering from chronic heart failure New York Heart Association Class IV.

17. Poorly controlled hypertension (>160 mmHg systolic pressure or >100 mmHg 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, would have made participation unacceptable.

20. Subject was not using adequate contraceptive precautions.

21. Subject of childbearing potential was evidently pregnant (e.g., positive human
chorionic gonadotropin test) or was breast feeding.

22. Body weight <35 kg.

23. Subject currently was enrolled in or had not yet completed at least 30 days since
ending other investigational device or drug studies, or subject was receiving other
investigational agent(s).

24. Subject would not be available for follow-up assessment.

25. Subject had any kind of disorder that compromised the ability of the subject to give
written informed consent and/or to comply with study procedures.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
Accrual to date
Final
626
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Gosford Hospital - Renal Research - Gosford
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Belgium
State/province [3] 0 0
Baudour
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Novy Jicin
Country [5] 0 0
Denmark
State/province [5] 0 0
Frederica
Country [6] 0 0
France
State/province [6] 0 0
Grenoble Cedex
Country [7] 0 0
Germany
State/province [7] 0 0
Demmin
Country [8] 0 0
Greece
State/province [8] 0 0
Arta
Country [9] 0 0
Italy
State/province [9] 0 0
Anzio
Country [10] 0 0
Netherlands
State/province [10] 0 0
Amersfoort
Country [11] 0 0
Norway
State/province [11] 0 0
Trondheim
Country [12] 0 0
Poland
State/province [12] 0 0
Warszawa
Country [13] 0 0
Portugal
State/province [13] 0 0
Lisboa
Country [14] 0 0
Romania
State/province [14] 0 0
Bucuresti
Country [15] 0 0
Spain
State/province [15] 0 0
Santander
Country [16] 0 0
Sweden
State/province [16] 0 0
Stockholm
Country [17] 0 0
Turkey
State/province [17] 0 0
Adana
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vifor Pharma
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
American Regent, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
ICON Clinical Research
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using
targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic
kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00994318
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Iain Macdougall
Address 0 0
King's College Hospital NHS Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00994318