AnemiaPhase 3NCT00236964
Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis
A Phase 3 study testing Iron Sucrose + Erythropoietin and Oral Iron + Erythropoietin in people with Anemia, run by American Regent, Inc..
Trial summary
The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Iron Sucrose + Erythropoietin and Oral Iron + Erythropoietin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 23 Feb 2001to 30 May 2002
- Phase
- Phase 3
- 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
- Creatine Clearance <40 mL/min
- Average Baseline Hemoglobin < 10.5g/dL
- Serum Transferrin Saturation (TSAT) < 25% and Ferritin <300ng/mL
Who cannot join
- Blood Transfusion within 30days
- Uncontrolled Hypertension
- Suffering form concommitant disease of the liver
- Serious bacterial infection
- Pregnancy / lactation
- Symptomatic HIV
- Expected to under dialysis or renal transplant during study
About this study
The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis.
Read the detailed description
Randomized open-label multicenter active-controlled study of anemic patients with Chronic Renal Failure who are not yet receiving dialysis. The duration of the study was five months. After screening procedures including multiple hemoglobin values, patients were randomly assigned to either IV Iron Sucrose (200mg X 5) or oral iron sulfate (325mg TID)for 29 days. Safety assessments included the recording of all adverse events, physical examinations, vital signs, electrocardiograms and clinical laboratory tests. Efficacy parameters included hematologic parameters.
- Conditions
- Anemia
- Being tested
- Iron Sucrose + Erythropoietin, Oral Iron + Erythropoietin
- Keywords
- Anemia, Chronic Kidney Disease
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Sucrose + ErythropoietinDrug
Also called Venofer
The total dose of iron sucrose was 1,000 mg. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36.
Oral Iron + ErythropoietinDrug
Also called Ferrous sulfate
Oral iron 325 mg three time daily for 29 days. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36.
| Study group | Role | What they receive |
|---|---|---|
| Iron Sucrose | Experimental | Iron sucrose 200 mg intravenous on Days 1, 8, 15, 22, and 29 Receives: Drug: Iron Sucrose + Erythropoietin |
| Oral Iron | Active comparator | Oral ferrous sulfate 325 mg three times a day on Days 1 to 29. Receives: Drug: Oral Iron + Erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Hemoglobin
Change in hemoglobin g/dL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).
Measured: Baseline and Day 43
Mean Change in Serum Ferritin
Change in Ferritin ng/mL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).
Measured: Baseline and Day 43
Secondary outcomes (2)
Clinical Success (Change in Hemoglobin)
Participants were considered to have achieved clinical success if they attained a change in hemoglobin ≥0.8 g/dL. The difference from baseline to Day 43 was calculated and rounded.
Measured: Baseline and Day 43
Clinical success (change in Ferritin)
Participants were considered to have achieved clinical success if they attained a change in ferritin ≥160 ng/mL. The difference from baseline to Day 43 was calculated and rounded.
Measured: Baseline and Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study start23 Feb 2001
- Primary completion30 May 2002
- Study completion30 May 2002
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 AnemiaStudies 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Falone, MD, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236964
- Sponsor's protocol ID
- 1VEN99012
- Status last verified
- Jan 2018
- First submitted
- 7 Oct 2005
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Charytan C, Qunibi W, Bailie GR; Venofer Clinical Studies Group. Comparison of intravenous iron sucrose to oral iron in the treatment of anemic patients with chronic kidney disease not on dialysis. Nephron Clin Pract. 2005;100(3):c55-62. doi: 10.1159/000085049. Epub 2005 Apr 11.
PubMed 15824508
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis
- ClinicalTrials.gov ID
- NCT00236964
- Acronym / sponsor ID
- 1VEN99012
- Conditions
- Anemia
- Keywords
- Anemia, Chronic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2001 (actual)
- Primary completion
- 30 May 2002 (actual)
- Study completion
- 30 May 2002 (actual)
- First posted
- 12 Oct 2005 (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.
The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis.
Detailed description
Randomized open-label multicenter active-controlled study of anemic patients with Chronic Renal Failure who are not yet receiving dialysis. The duration of the study was five months. After screening procedures including multiple hemoglobin values, patients were randomly assigned to either IV Iron Sucrose (200mg X 5) or oral iron sulfate (325mg TID)for 29 days. Safety assessments included the recording of all adverse events, physical examinations, vital signs, electrocardiograms and clinical laboratory tests. Efficacy parameters included hematologic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron Sucrose | Experimental | Drug: Iron Sucrose + ErythropoietinIron sucrose 200 mg intravenous on Days 1, 8, 15, 22, and 29 |
| Oral Iron | Active comparator | Drug: Oral Iron + ErythropoietinOral ferrous sulfate 325 mg three times a day on Days 1 to 29. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Creatine Clearance <40 mL/min
- Average Baseline Hemoglobin < 10.5g/dL
- Serum Transferrin Saturation (TSAT) < 25% and Ferritin <300ng/mL
Key exclusion criteria (7 listed)
- Blood Transfusion within 30days
- Uncontrolled Hypertension
- Suffering form concommitant disease of the liver
- Serious bacterial infection
- Pregnancy / lactation
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 Sucrose + ErythropoietinAlso: VenoferThe total dose of iron sucrose was 1,000 mg. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36. | Drug | Iron Sucrose |
| Oral Iron + ErythropoietinAlso: Ferrous sulfateOral iron 325 mg three time daily for 29 days. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36. | Drug | Oral Iron |
Primary outcome
Mean Change in Hemoglobin
Time frame: Baseline and Day 43
Change in hemoglobin g/dL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).
Mean Change in Serum Ferritin
Time frame: Baseline and Day 43
Change in Ferritin ng/mL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).
2 secondary outcomes
Clinical Success (Change in Hemoglobin)
Time frame: Baseline and Day 43
Clinical success (change in Ferritin)
Time frame: Baseline and Day 43
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 9 May 2025.
- Results publication: PubMed 15824508Charytan C, Qunibi W, Bailie GR; Venofer Clinical Studies Group. Comparison of intravenous iron sucrose to oral iron in the treatment of anemic patients with chronic kidney disease not on dialysis. Nephron Clin Pract. 2005;100(3):c55-62. doi: 10.1159/000085049. Epub 2005 Apr 11.
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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.
Mark Falone, MD study director
Medical Director
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iron Sucrose + Erythropoietin and Oral Iron + Erythropoietin in people with Anemia, run by American Regent, Inc..
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 3 inclusion and 7 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 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Mean Change in Hemoglobin (time frame: Baseline and Day 43). The study lists 2 primary outcomes in all. 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 NCT00236964, 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 9 May 2025.