Iron DeficiencyPhase 4NCT02392910
Hospitalization & Mortality in Patients With Iron Deficiency CKD and HF Treated With i.v. Iron.
A Phase 4 study testing Iron Sucrose in people with Iron Deficiency and Heart Failure, run by Hospital Aleman at 1 site in Argentina.
Trial summary
Iron deficiency, independent of anemia, appears to increase morbidity and mortality as well as impairing health-related quality of life in chronic heart failure (CHF), and these effects are compounded when patients also experience chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency, Heart Failure, Chronic Kidney Disease
- What is being tested?
- Iron Sucrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteArgentina
- Study dates
- Mar 2006to Feb 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- LV ejection fraction (EF) ≤ 35%
- New York Heart Association (NYHA) functional class II to IV
- Anemia with an iron deficit defined by Hb 12.5 g/dl for men and 11.5 g/dl for women, and some of the following: serum ferritin 100 ng/ml and/or with transferrin saturation (TSAT) 20%
- Creatinine clearance 90 ml/min.
Who cannot join
- Hemodialysis therapy
- Anemia not due to iron deficiency
- NYHA functional class I
- History of allergy to the iron supplements
- Acute bacterial infections, parasitism known in the 4 previous weeks
- Neoplasm
Show all 12Show fewer
- Chronic digestive diseases
- Hypothyroidism
- Congenital cardiopathies
- Receiving iron supplements in the 4 previous weeks
- Receiving rhEPO in the 4 previous weeks
- History of hospitalization during the 4 weeks before enrollment into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hospitalization and Mortality in Iron Deficient, Anemic Patients With Chronic Kidney (CKD) and Heart Failure Receiving Intravenous Iron Therapy: A Five Year Follow-up From a Pilot Study
Iron deficiency, independent of anemia, appears to increase morbidity and mortality as well as impairing health-related quality of life in chronic heart failure (CHF), and these effects are compounded when patients also experience chronic kidney disease (CKD). This study was designed to determine the effects of intravenous iron treatment on morbidity and mortality following an initial 6-month period and a longer period of up to 5 years.
Read the detailed description
Effect of i.v. iron sucrose on iron parameters and anemia
- During the original 6 month trial, patients in the i.v. iron group received 1000mg iron per the protocol. No patients required iron in the subsequent 6 months.
- During the subsequent follow-up, patients required a mean of between 165 and 274 mg iron per year (range: 0 to 600 mg per patient per year).
- Post the initial 1000mg iron, 19 out of 20 patients required at least a second dose of i.v. iron. Most patients required only one or two doses per year.
- The average time to requiring a second iron administration was 14.5 ± 2.7 months (range: 14 months, 23 months).
- Correction of iron deficiency (ID) resulted in statistically significant increases in transferrin saturation (TSAT) throughout the study (p < 0.01 untreated group). At all measured points, TSAT values in the treated group were at least on target (> 20% increase).
- For serum ferritin, significant differences were observed at 6 months and 1 year however this difference was not observed at 5 years post baseline where serum ferritin values were 173ng/mL and 167ng/mL for the control and IV iron groups, respectively.
- Statistically significant improvements versus the untreated group were observed for both hemoglobin (Hb) and creatinine clearance (CrCl) as well as for left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) functional class at each year.
Effect of i.v. iron sucrose on hospitalizations and mortality
- There were numerically fewer hospitalization reported at 6 months compared to those among untreated patients (0% and 25%, respectively), although the difference versus untreated patients was not statistically significant (p=ns).
- At 1 year after commencing the original study, the number of patients requiring a hospitalization (for any reason) was 50% in the control group and 10% in the IV iron group (p<0.01).
- By 5 years follow-up these rates had increased to 85% in the control arm and 20% in the IV iron treated group (p<0.01).
- In relation to all-cause mortality, there were no deaths in either group after the first 6 months. The number of deaths due to any cause after year 1 had increased in both groups (20% in the untreated group, 5% in the treated group; p=ns).
- At 5 years follow-up, 11 (55%) of patients in the control arm were deceased, compared with 4 (20%) in the IV iron treated group (p < 0.05).
- Conditions
- Iron Deficiency, Heart Failure, Chronic Kidney Disease
- Being tested
- Iron Sucrose, Placebo
- Keywords
- Iron Sucrose, Mortality, Hospitalization
- Medical subject headings
- Iron Deficiencies, Heart Failure, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron SucroseDrug
Also called Venofer
At each visit, the patient lay on a stretcher and underwent a vein cannulation in the forearm with a commercial canula no. 16, which was connected to IV tubing that was connected to a bag contained 200 ml isotonic saline solution 0.9% plus 200 mg of Iron Sucrose. Each infusion was administered throughout 60 min. This scheme was followed for 5 consecutive weeks.
PlaceboDrug
Also called Sodium Chloride 0.9%
At each visit, the patient lay on a stretcher and underwent a vein cannulation in the forearm with a commercial canula no. 16, which was connected to IV tubing that was connected to a bag of isotonic saline solution 0.9% (200 ml). Each infusion was administered throughout 60 min. This scheme was followed for 5 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Placebo Receives: Drug: Placebo |
| Group B | Other | Iron Sucrose Receives: Drug: Iron Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 5 years
Secondary outcomes (1)
Hospitalization
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMar 2006
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Aleman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Eduardo Toblli, Hospital Aleman
- Investigators
- Jorge E Toblli, MD; PhD, Principal investigator, Hospital Aleman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392910
- Sponsor's protocol ID
- 5427-06/07
- Status last verified
- Mar 2015
- First submitted
- 15 Mar 2015
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Toblli JE, Lombrana A, Duarte P, Di Gennaro F. Intravenous iron reduces NT-pro-brain natriuretic peptide in anemic patients with chronic heart failure and renal insufficiency. J Am Coll Cardiol. 2007 Oct 23;50(17):1657-65. doi: 10.1016/j.jacc.2007.07.029.
PubMed 17950147
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospitalization and Mortality in Iron Deficient, Anemic Patients With Chronic Kidney (CKD) and Heart Failure Receiving Intravenous Iron Therapy: A Five Year Follow-up From a Pilot Study
- ClinicalTrials.gov ID
- NCT02392910
- Acronym / sponsor ID
- 5427-06/07
- Conditions
- Iron Deficiency, Heart Failure, Chronic Kidney Disease
- Keywords
- Iron Sucrose, Mortality, Hospitalization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital AlemanUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Iron deficiency, independent of anemia, appears to increase morbidity and mortality as well as impairing health-related quality of life in chronic heart failure (CHF), and these effects are compounded when patients also experience chronic kidney disease (CKD). This study was designed to determine the effects of intravenous iron treatment on morbidity and mortality following an initial 6-month period and a longer period of up to 5 years.
Detailed description
Effect of i.v. iron sucrose on iron parameters and anemia
- During the original 6 month trial, patients in the i.v. iron group received 1000mg iron per the protocol. No patients required iron in the subsequent 6 months.
- During the subsequent follow-up, patients required a mean of between 165 and 274 mg iron per year (range: 0 to 600 mg per patient per year).
- Post the initial 1000mg iron, 19 out of 20 patients required at least a second dose of i.v. iron. Most patients required only one or two doses per year.
- The average time to requiring a second iron administration was 14.5 ± 2.7 months (range: 14 months, 23 months).
- Correction of iron deficiency (ID) resulted in statistically significant increases in transferrin saturation (TSAT) throughout the study (p < 0.01 untreated group). At all measured points, TSAT values in the treated group were at least on target (> 20% increase).
- For serum ferritin, significant differences were observed at 6 months and 1 year however this difference was not observed at 5 years post baseline where serum ferritin values were 173ng/mL and 167ng/mL for the control and IV iron groups, respectively.
- Statistically significant improvements versus the untreated group were observed for both hemoglobin (Hb) and creatinine clearance (CrCl) as well as for left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) functional class at each year.
Effect of i.v. iron sucrose on hospitalizations and mortality
- There were numerically fewer hospitalization reported at 6 months compared to those among untreated patients (0% and 25%, respectively), although the difference versus untreated patients was not statistically significant (p=ns).
- At 1 year after commencing the original study, the number of patients requiring a hospitalization (for any reason) was 50% in the control group and 10% in the IV iron group (p<0.01).
- By 5 years follow-up these rates had increased to 85% in the control arm and 20% in the IV iron treated group (p<0.01).
- In relation to all-cause mortality, there were no deaths in either group after the first 6 months. The number of deaths due to any cause after year 1 had increased in both groups (20% in the untreated group, 5% in the treated group; p=ns).
- At 5 years follow-up, 11 (55%) of patients in the control arm were deceased, compared with 4 (20%) in the IV iron treated group (p < 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Drug: PlaceboPlacebo |
| Group B | Other | Drug: Iron SucroseIron Sucrose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- LV ejection fraction (EF) ≤ 35%
- New York Heart Association (NYHA) functional class II to IV
- Anemia with an iron deficit defined by Hb 12.5 g/dl for men and 11.5 g/dl for women, and some of the following: serum ferritin 100 ng/ml and/or with transferrin saturation (TSAT) 20%
- Creatinine clearance 90 ml/min.
Key exclusion criteria (12 listed)
- Hemodialysis therapy
- Anemia not due to iron deficiency
- NYHA functional class I
- History of allergy to the iron supplements
- Acute bacterial infections, parasitism known in the 4 previous weeks
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 |
|---|---|---|
| Iron SucroseAlso: VenoferAt each visit, the patient lay on a stretcher and underwent a vein cannulation in the forearm with a commercial canula no. 16, which was connected to IV tubing that was connected to a bag contained 200 ml isotonic saline solution 0.9% plus 200 mg of Iron Sucrose. Each infusion was administered throughout 60 min. This scheme was followed for 5 consecutive weeks. | Drug | Group B |
| PlaceboAlso: Sodium Chloride 0.9%At each visit, the patient lay on a stretcher and underwent a vein cannulation in the forearm with a commercial canula no. 16, which was connected to IV tubing that was connected to a bag of isotonic saline solution 0.9% (200 ml). Each infusion was administered throughout 60 min. This scheme was followed for 5 consecutive weeks. | Drug | Group A |
Primary outcome
mortality
Time frame: 5 years
1 secondary outcome
Hospitalization
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Background: PubMed 17950147Toblli JE, Lombrana A, Duarte P, Di Gennaro F. Intravenous iron reduces NT-pro-brain natriuretic peptide in anemic patients with chronic heart failure and renal insufficiency. J Am Coll Cardiol. 2007 Oct 23;50(17):1657-65. doi: 10.1016/j.jacc.2007.07.029.
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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.
Jorge E Toblli, MD; PhD principal investigator
Hospital Aleman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron Sucrose in people with Iron Deficiency and Heart Failure, run by Hospital Aleman at 1 site in Argentina.
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 4 inclusion and 12 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 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mortality (time frame: 5 years). 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 NCT02392910, which also lists 1 linked publication.
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 19 Mar 2015.