AnemiaPhase 4NCT00239642
Safety and Efficacy of Iron Sucrose in Children
A Phase 4 study testing Venofer (iron sucrose injection) in people with Anemia and Chronic Kidney Disease, run by American Regent, Inc. at 1 site in United States.
Trial summary
Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Anemia, Chronic Kidney Disease
- What is being tested?
- Venofer (iron sucrose injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Apr 2010
- Phase
- Phase 4
- 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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between 2 to 21 years of age
- Patients on stable hemodialysis (HD) or peritoneal dialysis (PD) regimen for 3 months for ≥ 3 months
- Non-dialysis dependent (NDD) patients with glomerular filtration rate (GFR) <60
- Hemoglobin (Hgb) ≥ 11g/dL to ≤ 13.5g/dL
- Ferritin ≤ 800 ng/mL
- Transferrin saturation (TSAT) ≥ 20% to ≤ 50%
- Received stable erythropoietin (EPO) regimen for ≥ 8 weeks prior to the qualifying screening visit
Who cannot join
- Known hypersensitivity to iron sucrose
- Severe diseased of the liver, cardiovascular system, or hemopoietic system
- Serious infection requiring hospitalization
- Significant blood loss within the last 3 months
- Bleeding disorders
- Pregnancy / Lactation
Show all 9Show fewer
- Actively being treated for asthma
- Hemoglobinopathy
- Receiving a myelosuppressive drug
Trial locations and contacts
1 site in 1 country.
United States1 site
Luitpold Pharmaceutials
Norristown, Pennsylvania, 19403
About this study
Official title: Comparison of the Safety and Efficacy of Three Iron Sucrose Maintenance Regimens in Pediatric Chronic Kidney Disease (CKD) Patients
Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients
Read the detailed description
Randomized, controlled, open label trial of pediatric CKD patients on stable erythropoietin (EPO) therapy. Patients will be followed for 12 weeks to assess safety (incidence of adverse events) and efficacy (clinical success)
- Conditions
- Anemia, Chronic Kidney Disease
- Being tested
- Venofer (iron sucrose injection)
- Keywords
- Iron, Anemia, CKD
- 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.
Venofer (iron sucrose injection)Drug
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Venofer (iron sucrose injection)Drug
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Venofer (iron sucrose injection)Drug
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Venofer (0.5 mg/kg) | Experimental | 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously Receives: Drug: Venofer (iron sucrose injection) |
| Venofer (1.0 mg/kg) | Experimental | 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously Receives: Drug: Venofer (iron sucrose injection) |
| Venofer (2.0 mg/kg) | Experimental | 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously Receives: Drug: Venofer (iron sucrose injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event
Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm
Measured: baseline through week 12
Secondary outcomes (8)
Number of Subjects Achieving Clinical Success
Summary of the Number of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and Stable EPO Dosing (±25% of Baseline Dose)
Measured: anytime during the 12 week post-baseline period
Percentage (%) of Subjects Achieving Clinical Success
Summary of the Percentage (%) of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and stable EPO Dosing (±25% of Baseline Dose)
Measured: anytime during the 12 week post-baseline period
Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive
Measured: anytime during the 12-week post-baseline period
Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
Measured: anytime during the 12 week post-baseline period
Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive
Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive
Measured: anytime during the 12 week post-baseline period
Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive
Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive
Measured: anytime during the 12 week post-baseline period
Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline
Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease >25% in EPO dose from Baseline
Measured: anytime during the 12 week post-baseline period
Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline
Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease >25% in EPO Dose from Baseline
Measured: anytime during the 12 week post-baseline period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startJul 2005
- Primary completionJan 2009
- Study completionApr 2010
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark A Falone, MD, Study director, American Regent, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239642
- Sponsor's protocol ID
- 1VEN03017
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2005
- Last updated
- 17 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Safety and Efficacy of Three Iron Sucrose Maintenance Regimens in Pediatric Chronic Kidney Disease (CKD) Patients
- ClinicalTrials.gov ID
- NCT00239642
- Acronym / sponsor ID
- 1VEN03017
- Conditions
- Anemia, Chronic Kidney Disease
- Keywords
- Iron, Anemia, CKD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 17 Oct 2005 (estimated)
- Results
- Posted 10 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients
Detailed description
Randomized, controlled, open label trial of pediatric CKD patients on stable erythropoietin (EPO) therapy. Patients will be followed for 12 weeks to assess safety (incidence of adverse events) and efficacy (clinical success)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Venofer (0.5 mg/kg) | Experimental | Drug: Venofer (iron sucrose injection)0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
| Venofer (1.0 mg/kg) | Experimental | Drug: Venofer (iron sucrose injection)1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
| Venofer (2.0 mg/kg) | Experimental | Drug: Venofer (iron sucrose injection)2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patients between 2 to 21 years of age
- Patients on stable hemodialysis (HD) or peritoneal dialysis (PD) regimen for 3 months for ≥ 3 months
- Non-dialysis dependent (NDD) patients with glomerular filtration rate (GFR) <60
- Hemoglobin (Hgb) ≥ 11g/dL to ≤ 13.5g/dL
- Ferritin ≤ 800 ng/mL
Key exclusion criteria (9 listed)
- Known hypersensitivity to iron sucrose
- Severe diseased of the liver, cardiovascular system, or hemopoietic system
- Serious infection requiring hospitalization
- Significant blood loss within the last 3 months
- Bleeding disorders
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 (iron sucrose injection)0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously | Drug | Venofer (0.5 mg/kg) |
| Venofer (iron sucrose injection)1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously | Drug | Venofer (1.0 mg/kg) |
| Venofer (iron sucrose injection)2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously | Drug | Venofer (2.0 mg/kg) |
Primary outcome
Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event
Time frame: baseline through week 12
Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm
8 secondary outcomes
Number of Subjects Achieving Clinical Success
Time frame: anytime during the 12 week post-baseline period
Percentage (%) of Subjects Achieving Clinical Success
Time frame: anytime during the 12 week post-baseline period
Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
Time frame: anytime during the 12-week post-baseline period
Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
Time frame: anytime during the 12 week post-baseline period
Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive
Time frame: anytime during the 12 week post-baseline period
Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive
Time frame: anytime during the 12 week post-baseline period
Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline
Time frame: anytime during the 12 week post-baseline period
Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline
Time frame: anytime during the 12 week post-baseline period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 4 study testing Venofer (iron sucrose injection) in people with Anemia and Chronic Kidney Disease, 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 7 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 17 Nov 2021. 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 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?
Yes. Results are posted in the registry (first posted 10 Jan 2012). 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?
Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event (time frame: baseline through week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2021.