AnemiaPhase 3NCT00236938

Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

A Phase 3 study testing Venofer and stable erythropoietin (EPO) regimen and stable erythropoietin (EPO) regimen in people with Anemia, run by American Regent, Inc..

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

This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal 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?: Venofer and stable erythropoietin (EPO) regimen and stable erythropoietin (EPO) regimen
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: No sites listed yet
Study dates: Jul 2002to 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 >= 9.5 and <= 11.5 g/dL.
Ferritin <= 500 ng/ml.
Serum Transferrin Saturation (TSAT) <= 25%.
Stable erythropoietin (EPO) Regimen for 8 weeks.
No iron for last 4 weeks before randomization.

Who cannot join

Known Sensitivity to Iron Sucrose.
Suffering concomitant severe diseases of the liver \& cardiovascular system.
Pregnancy / Lactation.
Inadequate dialysis.
Current treatment for asthma.
Significant blood loss.

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Probability of need for transfusion or transfusion within 1 week of enrollment.
Anticipated major surgery.
Hemochromatosis / hemosiderosis.

About this study

This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.

Read the detailed description

This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. Erythropoietin regimen was to remain stable. Patients were followed to day 71 for safety and efficacy.

Conditions: Anemia
Being tested: Venofer and stable erythropoietin (EPO) regimen, stable erythropoietin (EPO) regimen
Keywords: iron, peritoneal dialysis, anemia
Medical subject headings: Anemia

What participants receive

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

Venofer and stable erythropoietin (EPO) regimenDrug
Also called Iron Sucrose
Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
stable erythropoietin (EPO) regimenDrug
Also called EPO
Stable erythropoietin (EPO) dose and no supplemental iron.

Study groups in NCT00236938
Study group	Role	What they receive
Group A	Experimental	Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29. Receives: Drug: Venofer and stable erythropoietin (EPO) regimen
Group B	Active comparator	Stable erythropoietin (EPO) dose and no supplemental iron. Receives: Drug: stable erythropoietin (EPO) regimen

What is being measured

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

Mean Change From Baseline to the Highest Hemoglobin up to Day 71
Measured: Change from Baseline up to Day 71

Secondary outcomes (3)

The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71
Measured: Change from Baseline up to Day 71
The Mean Change From Baseline to the Highest Ferritin up to Day 71
Measured: Change from Baseline up to Day 71
The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71
Measured: Change from Baseline up to Day 71

Timeline

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

Jul 2002Oct 2004

First posted12 Oct 2005 (estimated)
Study startJul 2002
Primary completionSep 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: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00236938
Sponsor's protocol ID: 1VEN02021 / 1VEN02022
Status last verified: Apr 2021
First submitted: 10 Oct 2005
Last updated: 19 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Singh H, Reed J, Noble S, Cangiano JL, Van Wyck DB; United States Iron Sucrose (Venofer) Clinical Trials Group. Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythropoiesis-stimulating agents for anemia: a randomized, controlled trial. Clin J Am Soc Nephrol. 2006 May;1(3):475-82. doi: 10.2215/CJN.01541005. Epub 2006 Mar 29.
PubMed 17699248

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?

Official record

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All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis
ClinicalTrials.gov ID: NCT00236938
Acronym / sponsor ID: 1VEN02021 / 1VEN02022
Conditions: Anemia
Keywords: iron, peritoneal dialysis, anemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: American Regent, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2002
Primary completion: Sep 2004 (actual)
Study completion: Oct 2004 (actual)
First posted: 12 Oct 2005 (estimated)
Results: Posted 7 Sep 2009

Clinical summary

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

This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.

Detailed description

Study design

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

Arm	Type	Receives
Group A	Experimental	Drug: Venofer and stable erythropoietin (EPO) regimenFixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
Group B	Active comparator	Drug: stable erythropoietin (EPO) regimenStable erythropoietin (EPO) dose and no supplemental iron.

Who may qualify

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

Key inclusion criteria (5 listed)

Hemoglobin >= 9.5 and <= 11.5 g/dL.
Ferritin <= 500 ng/ml.
Serum Transferrin Saturation (TSAT) <= 25%.
Stable erythropoietin (EPO) Regimen for 8 weeks.
No iron for last 4 weeks before randomization.

Key exclusion criteria (9 listed)

Known Sensitivity to Iron Sucrose.
Suffering concomitant severe diseases of the liver \& cardiovascular system.
Pregnancy / Lactation.
Inadequate dialysis.
Current treatment for asthma.

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
Venofer and stable erythropoietin (EPO) regimenAlso: Iron SucroseFixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.	Drug	Group A
stable erythropoietin (EPO) regimenAlso: EPOStable erythropoietin (EPO) dose and no supplemental iron.	Drug	Group B

Primary outcome

Mean Change From Baseline to the Highest Hemoglobin up to Day 71
Time frame: Change from Baseline up to Day 71

3 secondary outcomes

The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71
Time frame: Change from Baseline up to Day 71
The Mean Change From Baseline to the Highest Ferritin up to Day 71
Time frame: Change from Baseline up to Day 71
The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71
Time frame: Change from Baseline up to Day 71

Results and safety

Results posted to the registry on 7 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: Venofer and Erythropoietin EPO Fixed Dose	75	62
Group B: Erythropoietin EPO Fixed Dose Only	46	26

Primary outcome: Mean Change From Baseline to the Highest Hemoglobin up to Day 71

Time frame: Change from Baseline up to Day 71. Mean (Standard Deviation). Unit: g/dL

Measure	Group A: Venofer and Erythropoietin EPO Fixed Dose n = 66	Group B: Erythropoietin EPO Fixed Dose Only n = 30
Value	1.3 (1.10)	.7 (1.10)

Population analysed: Intent-to-Treat Population (ITT): All safety population subjects who received at least 1 dose of study medication or EPO and had at least 1 post-baseline efficacy measurement.

3 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Group A: Venofer and Erythropoietin EPO Fixed Dose	9 of 75 (12%)	33 of 75 (44%)	Not reported
Group B: Erythropoietin EPO Fixed Dose Only	5 of 46 (10.9%)	20 of 46 (43.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17699248Singh H, Reed J, Noble S, Cangiano JL, Van Wyck DB; United States Iron Sucrose (Venofer) Clinical Trials Group. Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythropoiesis-stimulating agents for anemia: a randomized, controlled trial. Clin J Am Soc Nephrol. 2006 May;1(3):475-82. doi: 10.2215/CJN.01541005. Epub 2006 Mar 29.

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Not yet recruitingObservational study
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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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Venofer and stable erythropoietin (EPO) regimen and stable erythropoietin (EPO) regimen 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 5 inclusion and 9 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 May 2021. 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?

Yes. Results are posted in the registry (first posted 7 Sep 2009). 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?

Mean Change From Baseline to the Highest Hemoglobin up to Day 71 (time frame: Change from Baseline up to Day 71). 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 NCT00236938, 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 May 2021.