Iron Deficiency AnaemiaPhase 3FIND-CKDNCT00994318
Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
A Phase 3 study testing FCM (Ferric carboxymaltose) high ferritin target, FCM (Ferric carboxymaltose) low ferritin target and Oral Iron (Ferrous sulphate) in people with Iron Deficiency Anaemia and Chronic Kidney Disease, run by Vifor Pharma at 19 sites in 19 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anaemia, Chronic Kidney Disease
- What is being tested?
- FCM (Ferric carboxymaltose) high ferritin target, FCM (Ferric carboxymaltose) low ferritin target and Oral Iron (Ferrous sulphate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 626 participants
- Where
- 19 sitesin 19 countries
- Study dates
- Dec 2009to Feb 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- 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.
- 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.
- 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.
- 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.
- ESA naïve; no exposure to ESA in last 4 months prior to randomisation.
- Females of childbearing potential must have had a negative pregnancy test, using any medically acceptable assessment, prior to randomisation.
- Before any study specific procedure, the appropriate written informed consent must have been obtained.
Who cannot join
- History of acquired iron overload.
- Known hypersensitivity reaction to any component of ferrous sulphate or FCM. Subjects with hypersensitivity to other forms of iron were permitted to participate.
- Documented history of discontinuing oral iron products due to significant gastrointestinal (GI) distress.
- Screening TSAT >40%.
- 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).
- History of chronic alcohol abuse (alcohol consumption >40 g/day).
Show all 25Show fewer
- Chronic liver disease and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range.
- Active human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome or active hepatitis B or C virus infection.
- Anaemia due to reasons other than iron deficiency (e.g., haemoglobinopathy). Subjects with treated Vitamin B12 or folic acid deficiency were permitted.
- IV iron and/or blood transfusion in previous 30 days prior to screening (or during the screening period).
- 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.
- Immunosuppressive therapy that may have led to anaemia (e.g., cyclophosphamide, azathioprine, or mycophenolate mofetil). Steroid therapy was permitted.
- Currently requiring renal dialysis.
- Anticipated dialysis or transplant during the study.
- Anticipated need for surgery that may have resulted in significant bleeding (>100 mL).
- Currently suffering from chronic heart failure New York Heart Association Class IV.
- Poorly controlled hypertension (>160 mmHg systolic pressure or >100 mmHg diastolic pressure).
- Acute coronary syndrome or stroke within the 3 months prior to screening.
- Currently suffering from concomitant, severe psychiatric disorders or other conditions which, in the opinion of the Investigator, would have made participation unacceptable.
- Subject was not using adequate contraceptive precautions.
- Subject of childbearing potential was evidently pregnant (e.g., positive human chorionic gonadotropin test) or was breast feeding.
- Body weight <35 kg.
- 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).
- Subject would not be available for follow-up assessment.
- 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.
Trial locations and contacts
19 sites in 19 countries.
19 sites in 19 countries
United States1 site
Trial Management Associates
Wilmington, North Carolina, 28401
Austria1 site
Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin IV
Innsbruck, 6020
Belgium1 site
RHMS Baudour - Department of Nephrology and Dialysis
Baudour, 7331
Czechia1 site
Nemocnice s poliklinikou v Novem Jicine, p.o. p.o. Interni oddeleni - nefrologie a dialyza
Nový Jičín, 74101
Denmark1 site
Lillebalt Frederica Sygehus Department of Nephrology
Frederica, 7000
Italy1 site
Ospedali Riuniti Anzio-Nettuno ASL ROMA H U.O. Nefrologia e Dialisi
Anzio, 00042
Netherlands1 site
Meander Medisch Centrum - Locatie Amersfoort Lichtenberg
Amersfoort, 3816 CP
Poland1 site
Miedzyleski Szpital Spec. Oddzial I Wewnetrzny I Nefrologii
Warsaw, 04-749
Romania1 site
Spitalul Clinic de Nefrologie"Dr Carol Davila"
Bucharest, 010731
Spain1 site
Hospital Universitario Marqués de Valdecilla - Servicio de Nefrología
Santander, 39008
Turkey (Türkiye)1 site
Cukurova University Medical Faculty Balcali Hospital - Department of Nephrology
Adana, 01330
About this study
Official 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
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).
Read the detailed description
After an initial screening period of up to 4 weeks, eligible subjects were randomised (1:1:2) to 1 of the following 3 treatment arms for a period of 52 weeks.
- FCM regimen (maximum single intravenous doses of 1,000 mg of iron) targeting a ferritin level of 400-600 mcg/L.
- FCM regimen (maximum single intravenous doses of 200 mg of iron) targeting a ferritin level of 100-200 mcg/L.
- Daily oral iron with 200 mg iron/day (100 mg twice daily)
- Conditions
- Iron Deficiency Anaemia, Chronic Kidney Disease
- Being tested
- FCM (Ferric carboxymaltose) high ferritin target, FCM (Ferric carboxymaltose) low ferritin target, Oral Iron (Ferrous sulphate)
- Keywords
- Ferinject Iron Deficiency Anaemia Chronic Kidney Disease
- Medical subject headings
- Anemia, Iron-Deficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCM (Ferric carboxymaltose) high ferritin targetDrug
Also called Ferinject, Injectafer
FCM (Ferric carboxymaltose) low ferritin targetDrug
Also called Ferinject, Injectafer
Oral Iron (Ferrous sulphate)Drug
Also called Ferrous sulphate
| Study group | Role | What they receive |
|---|---|---|
| FCM (high ferritin target) | Experimental | Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L Receives: Drug: FCM (Ferric carboxymaltose) high ferritin target |
| FCM (low ferritin target) | Experimental | Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L Receives: Drug: FCM (Ferric carboxymaltose) low ferritin target |
| Oral Iron | Active comparator | Ferrous sulphate 100 mg iron twice daily, continuous Receives: Drug: Oral Iron (Ferrous sulphate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan-Meier Survival Analysis for Time to Other Anemia Therapy or Hb Trigger
Endpoint reported number of participants with/without events and was reached:
- First time of initiation of additional or alternative anaemia management,
- First time the subject reached the Hb trigger. 3 primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve an alpha level of 0.05, performed in the following order:
- FCM (high ferritin target) compared with oral iron.
- FCM (high ferritin target) compared with FCM (low ferritin target).
- FCM (low ferritin target) compared with oral iron.
Sensitivity analyses of the primary endpoint were performed using the following alternative definitions of time to initiation of additional or alternative anaemia management:
- Without taking into account the Hb trigger.
- Taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.
- Taking into account the Hb trigger based on subjects with a complete set of Hb values from the central laboratory.
Measured: Up to 1 year after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American Regent, Inc., ICON Clinical Research
- Responsible party
- Sponsor
- Investigators
- Iain Macdougall, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994318
- Sponsor's protocol ID
- FER-CKD-01
- Acronym
- FIND-CKD
- Status last verified
- May 2014
- First submitted
- 12 Oct 2009
- Last updated
- 20 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Roger SD, Gaillard CA, Bock AH, Carrera F, Eckardt KU, Van Wyck DB, Cronin M, Meier Y, Larroque S, Macdougall IC; FIND-CKD Study Investigators. Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial. Nephrol Dial Transplant. 2017 Sep 1;32(9):1530-1539. doi: 10.1093/ndt/gfw264.
PubMed 28339831Macdougall IC, Bock AH, Carrera F, Eckardt KU, Gaillard C, Van Wyck D, Meier Y, Larroque S, Roger SD; FIND-CKD Study investigators. Renal function in patients with non-dialysis chronic kidney disease receiving intravenous ferric carboxymaltose: an analysis of the randomized FIND-CKD trial. BMC Nephrol. 2017 Jan 17;18(1):24. doi: 10.1186/s12882-017-0444-6.
PubMed 28095881Macdougall IC, Bock AH, Carrera F, Eckardt KU, Gaillard C, Van Wyck D, Roubert B, Nolen JG, Roger SD; FIND-CKD Study Investigators. FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia. Nephrol Dial Transplant. 2014 Nov;29(11):2075-84. doi: 10.1093/ndt/gfu201. Epub 2014 Jun 2.
PubMed 24891437
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00994318
- Acronym / sponsor ID
- FIND-CKD / FER-CKD-01
- Conditions
- Iron Deficiency Anaemia, Chronic Kidney Disease
- Keywords
- Ferinject Iron Deficiency Anaemia Chronic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- Vifor PharmaIndustry (pharma, biotech, devices)
- Collaborators
- American Regent, Inc., ICON Clinical Research
- Study start
- Dec 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Posted 7 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
After an initial screening period of up to 4 weeks, eligible subjects were randomised (1:1:2) to 1 of the following 3 treatment arms for a period of 52 weeks.
- FCM regimen (maximum single intravenous doses of 1,000 mg of iron) targeting a ferritin level of 400-600 mcg/L.
- FCM regimen (maximum single intravenous doses of 200 mg of iron) targeting a ferritin level of 100-200 mcg/L.
- Daily oral iron with 200 mg iron/day (100 mg twice daily)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FCM (high ferritin target) | Experimental | Drug: FCM (Ferric carboxymaltose) high ferritin targetFerric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L |
| FCM (low ferritin target) | Experimental | Drug: FCM (Ferric carboxymaltose) low ferritin targetFerric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L |
| Oral Iron | Active comparator | Drug: Oral Iron (Ferrous sulphate)Ferrous sulphate 100 mg iron twice daily, continuous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years of age.
- 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.
- 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.
- 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.
- 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.
Key exclusion criteria (25 listed)
- History of acquired iron overload.
- Known hypersensitivity reaction to any component of ferrous sulphate or FCM. Subjects with hypersensitivity to other forms of iron were permitted to participate.
- Documented history of discontinuing oral iron products due to significant gastrointestinal (GI) distress.
- Screening TSAT >40%.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FCM (Ferric carboxymaltose) high ferritin targetAlso: Ferinject, Injectafer | Drug | FCM (high ferritin target) |
| FCM (Ferric carboxymaltose) low ferritin targetAlso: Ferinject, Injectafer | Drug | FCM (low ferritin target) |
| Oral Iron (Ferrous sulphate)Also: Ferrous sulphate | Drug | Oral Iron |
Primary outcome
Kaplan-Meier Survival Analysis for Time to Other Anemia Therapy or Hb Trigger
Time frame: Up to 1 year after baseline
Endpoint reported number of participants with/without events and was reached: * First time of initiation of additional or alternative anaemia management, * First time the subject reached the Hb trigger. 3 primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve an alpha level of 0.05, performed in the following order: 1. FCM (high ferritin target) compared with oral iron. 2. FCM (high ferritin target) compared with FCM (low ferritin target). 3. FCM (low ferritin target) compared with oral iron. Sensitivity analyses of the primary endpoint were performed using the following alternative definitions of time to initiation of additional or alternative anaemia management: 1. Without taking into account the Hb trigger. 2. Taking into account the Hb trigger based on local laboratory data, instead of central laboratory data. 3. Taking into account the Hb trigger based on subjects with a complete set of Hb values from the central laboratory.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28339831Roger SD, Gaillard CA, Bock AH, Carrera F, Eckardt KU, Van Wyck DB, Cronin M, Meier Y, Larroque S, Macdougall IC; FIND-CKD Study Investigators. Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial. Nephrol Dial Transplant. 2017 Sep 1;32(9):1530-1539. doi: 10.1093/ndt/gfw264.
- Derived from this study: PubMed 28095881Macdougall IC, Bock AH, Carrera F, Eckardt KU, Gaillard C, Van Wyck D, Meier Y, Larroque S, Roger SD; FIND-CKD Study investigators. Renal function in patients with non-dialysis chronic kidney disease receiving intravenous ferric carboxymaltose: an analysis of the randomized FIND-CKD trial. BMC Nephrol. 2017 Jan 17;18(1):24. doi: 10.1186/s12882-017-0444-6.
- Derived from this study: PubMed 24891437Macdougall IC, Bock AH, Carrera F, Eckardt KU, Gaillard C, Van Wyck D, Roubert B, Nolen JG, Roger SD; FIND-CKD Study Investigators. FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia. Nephrol Dial Transplant. 2014 Nov;29(11):2075-84. doi: 10.1093/ndt/gfu201. Epub 2014 Jun 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iain Macdougall principal investigator
King's College Hospital NHS Trust
19 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FCM (Ferric carboxymaltose) high ferritin target, FCM (Ferric carboxymaltose) low ferritin target and Oral Iron (Ferrous sulphate) in people with Iron Deficiency Anaemia and Chronic Kidney Disease, run by Vifor Pharma at 19 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Australia, Austria, Belgium, Czechia and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kaplan-Meier Survival Analysis for Time to Other Anemia Therapy or Hb Trigger (time frame: Up to 1 year after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00994318, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.