AnemiaPhase 3NCT00236977

Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

A Phase 3 study testing Venofer and Ferrous Sulfate in people with Anemia, run by American Regent, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia
What is being tested?: Venofer and Ferrous Sulfate
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 182 participants
Where: 1 siteUnited States
Study dates: Aug 2003to Oct 2004
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

Hemoglobin < or = 11.5 gm/dL
Stable dose or not receiving EPO
Renal Anemia

Who cannot join

IV iron with last 6 months
Chronic infection, malignancy,major surgery within last month
Blood Transfusion with last two months
Significant blood loss within last 3 months
Concomitant sever diseases of the liver

Trial locations and contacts

1 site in 1 country.

United States1 site

Luitpold Pharmaceuticals
Valley Forge, Pennsylvania, 19403

Other trials in United States

About this study

Official title: Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

Read the detailed description

The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not receiving erythropoietin. After an extensive enrollment period, patients were randomized to receive oral iron (ferrous sulfate, 325mg three times daily (TID) for 56 days) or IV iron sucrose (total 1000mg, 500mg X 2 OR 200mg X 5 within two weeks). Erythropoietin schedule was to remain unchanged during the 56 day study.

Conditions: Anemia
Being tested: Venofer, Ferrous Sulfate
Keywords: CKD, iron, anemia
Medical subject headings: Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VenoferDrug
Also called iron sucrose tablets
iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
Ferrous SulfateDrug
Also called Oral Iron Tablets
oral iron tablets; 325 mg three times a day orally for 56 days

Study groups in NCT00236977
Study group	Role	What they receive
Venofer	Experimental	iron sucrose injection Receives: Drug: Venofer
Ferrous Sulfate	Active comparator	oral iron Receives: Drug: Ferrous Sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

Patients With an Increase in Hemoglobin >= 1gm/dL.
Measured: Change from Baseline up to Day 56

Secondary outcomes (6)

Number of Subjects With a Clinical Response
Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml)
Measured: Change from Baseline up to Day 56
Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56
Measured: Change from Baseline up to Day 56
Highest Change From Baseline in Ferritin (ng/mL) up to Day 56
Measured: Change from Baseline up to Day 56
Mean Change in Ferritin (ng/mL) From Baseline to Day 56
Measured: Change from Baseline at Day 56
Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56
Measured: Change from Baseline at Day 56
Mean Change From Baseline in Hemoglobin (g/dL) at Day 56
Measured: Change from Baseline at Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2003Oct 2004

First posted12 Oct 2005 (estimated)
Study startAug 2003
Primary completionOct 2004
Study completionOct 2004

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 (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: 182 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00236977
Sponsor's protocol ID: 1VEN03027
Status last verified: Sep 2020
First submitted: 7 Oct 2005
Last updated: 6 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S; United States Iron Sucrose (Venofer) Clinical Trials Group. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int. 2005 Dec;68(6):2846-56. doi: 10.1111/j.1523-1755.2005.00758.x.
PubMed 16316362

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia
ClinicalTrials.gov ID: NCT00236977
Acronym / sponsor ID: 1VEN03027
Conditions: Anemia
Keywords: CKD, iron, anemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 182 participants (actual)
Lead sponsor: American Regent, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2003
Primary completion: Oct 2004 (actual)
Study completion: Oct 2004 (actual)
First posted: 12 Oct 2005 (estimated)
Results: Posted 9 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Venofer	Experimental	Drug: Venoferiron sucrose injection
Ferrous Sulfate	Active comparator	Drug: Ferrous Sulfateoral iron

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Hemoglobin < or = 11.5 gm/dL
Stable dose or not receiving EPO
Renal Anemia

Key exclusion criteria (5 listed)

IV iron with last 6 months
Chronic infection, malignancy,major surgery within last month
Blood Transfusion with last two months
Significant blood loss within last 3 months
Concomitant sever diseases of the liver

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
VenoferAlso: iron sucrose tabletsiron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.	Drug	Venofer
Ferrous SulfateAlso: Oral Iron Tabletsoral iron tablets; 325 mg three times a day orally for 56 days	Drug	Ferrous Sulfate

Primary outcome

Patients With an Increase in Hemoglobin >= 1gm/dL.
Time frame: Change from Baseline up to Day 56

6 secondary outcomes

Number of Subjects With a Clinical Response
Time frame: Change from Baseline up to Day 56
Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56
Time frame: Change from Baseline up to Day 56
Highest Change From Baseline in Ferritin (ng/mL) up to Day 56
Time frame: Change from Baseline up to Day 56
Mean Change in Ferritin (ng/mL) From Baseline to Day 56
Time frame: Change from Baseline at Day 56
Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56
Time frame: Change from Baseline at Day 56
Mean Change From Baseline in Hemoglobin (g/dL) at Day 56
Time frame: Change from Baseline at Day 56

Results and safety

Results posted to the registry on 9 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Venofer	91	70
Ferrous Sulfate	91	72

Primary outcome: Patients With an Increase in Hemoglobin >= 1gm/dL.

Time frame: Change from Baseline up to Day 56. Number. Unit: participants

Measure	Venofer n = 79	Ferrous Sulfate n = 82
Value	35	23

Population analysed: Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year and 2 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Venofer	10 of 91 (11%)	37 of 91 (40.7%)	Not reported
Ferrous Sulfate	6 of 91 (6.6%)	42 of 91 (46.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 16316362Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S; United States Iron Sucrose (Venofer) Clinical Trials Group. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int. 2005 Dec;68(6):2846-56. doi: 10.1111/j.1523-1755.2005.00758.x.

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Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
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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 A Falone, MD study director

American Regent, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Venofer and Ferrous Sulfate in people with Anemia, run by American Regent, Inc. at 1 site in United States.

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 5 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 6 Oct 2020. 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 United States. 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 9 Mar 2010). 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?

Patients With an Increase in Hemoglobin >= 1gm/dL. (time frame: Change from Baseline up to Day 56). 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 NCT00236977, 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 6 Oct 2020.