AnemiaPhase 2NCT00239616
Pharmacokinetic of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin
A Phase 2 study testing Iron Sucrose injection in people with Anemia, run by American Regent, Inc..
Trial summary
This is an open-label, multicenter pharmacokinetic study of Hemodialysis (HD) or Peritoneal Dialysis (PD) patients receiving erythropoietin. Patients were administered 100mg of iron sucrose undiluted by slow IV push over 5 minutes. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anemia
- What is being tested?
- Iron Sucrose injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2002to 15 Sep 2003
- Phase
- Phase 2
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 12 and 18 years
- History of Chronic Renal Failure requiring HD or PD
- Hgb </= 13 g/dL
- Ferritin < 800 ng/ml
- Transferrin Saturation (TSAT) < 50%
- Receiving epoetin
Who cannot join
- Known Sensitivity to Iron Sucrose
- Severe Concomitant disease of the liver or cardiovascular system
- Serious bacterial Infection
- Pregnancy / Lactation
- Active Hepatitis
- Patients with Causes of iron deficiency other that Chronic Renal Failure
Show all 10Show fewer
- Blood Transfusion
- Body Weight < 25 kilograms
- Currently being treated for Asthma
- Received investigational drug within last 30 days
About this study
Official title: Open-label Multicenter, Pharmacokinetic Study of a Single Dose of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin
This is an open-label, multicenter pharmacokinetic study of Hemodialysis (HD) or Peritoneal Dialysis (PD) patients receiving erythropoietin. Patients were administered 100mg of iron sucrose undiluted by slow IV push over 5 minutes. Patients underwent serial blood draws and were subsequently followed for 7 days for safety endpoints.
Read the detailed description
This is an open-label, multicenter pharmacokinetic study of HD of adolescent PD patients receiving erythropoietin. Patients between the ages of 12 and 18 were administered 100mg of iron sucrose, undiluted by slow IV push over 5 minutes, and underwent serial blood draws. The patients were subsequently followed for 7 days for safety endpoints.
- Conditions
- Anemia
- Being tested
- Iron Sucrose injection
- Keywords
- Anemia, Pharmacokinetics
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Sucrose injectionDrug
Also called Venofer
Iron sucrose 100 mg dose
| Study group | Role | What they receive |
|---|---|---|
| Iron Sucrose | Experimental | A single 100 mg dose (1 vial), 20 mg/min injected over 5 minutes Receives: Drug: Iron Sucrose injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Measured Plasma Concentration (Cmax)
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Measured: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC 0-t)
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUC 0-t is defined as AUC from time 0 to the last data point
Measured: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Area Under the Curve From Time Zero Extrapolated to Infinity (AUC 0-∞)
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC 0-∞ is defined as area under the concentration vs. time curve from zero to infinity.
Measured: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Terminal Elimination Half-life (T1/2)
T1/2 refers to the time taken for concentration of a drug to decrease from its maximum concentration to half of Cmax
Measured: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Secondary outcomes (2)
Total Body Clearance (CL)
CL refers to the Dose/AUC 0-∞
Measured: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Volume of Distribution (Vd)
Vd refers to the ratio of amount of drug in a body (dose) to concentration of the drug that is measured in blood, plasma, and un-bound in interstitial fluid.
Measured: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
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 start5 Jun 2002
- Primary completion15 Sep 2003
- Study completion15 Sep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT00239616
- Sponsor's protocol ID
- 1VEN01016
- Status last verified
- Jan 2018
- First submitted
- 13 Oct 2005
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Multicenter, Pharmacokinetic Study of a Single Dose of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin
- ClinicalTrials.gov ID
- NCT00239616
- Acronym / sponsor ID
- 1VEN01016
- Conditions
- Anemia
- Keywords
- Anemia, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2002 (actual)
- Primary completion
- 15 Sep 2003 (actual)
- Study completion
- 15 Sep 2003 (actual)
- First posted
- 17 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.
This is an open-label, multicenter pharmacokinetic study of Hemodialysis (HD) or Peritoneal Dialysis (PD) patients receiving erythropoietin. Patients were administered 100mg of iron sucrose undiluted by slow IV push over 5 minutes. Patients underwent serial blood draws and were subsequently followed for 7 days for safety endpoints.
Detailed description
This is an open-label, multicenter pharmacokinetic study of HD of adolescent PD patients receiving erythropoietin. Patients between the ages of 12 and 18 were administered 100mg of iron sucrose, undiluted by slow IV push over 5 minutes, and underwent serial blood draws. The patients were subsequently followed for 7 days for safety endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron Sucrose | Experimental | Drug: Iron Sucrose injectionA single 100 mg dose (1 vial), 20 mg/min injected over 5 minutes |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age between 12 and 18 years
- History of Chronic Renal Failure requiring HD or PD
- Hgb </= 13 g/dL
- Ferritin < 800 ng/ml
- Transferrin Saturation (TSAT) < 50%
Key exclusion criteria (10 listed)
- Known Sensitivity to Iron Sucrose
- Severe Concomitant disease of the liver or cardiovascular system
- Serious bacterial Infection
- Pregnancy / Lactation
- Active Hepatitis
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 injectionAlso: VenoferIron sucrose 100 mg dose | Drug | Iron Sucrose |
Primary outcome
Maximum Measured Plasma Concentration (Cmax)
Time frame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC 0-t)
Time frame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUC 0-t is defined as AUC from time 0 to the last data point
Area Under the Curve From Time Zero Extrapolated to Infinity (AUC 0-∞)
Time frame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC 0-∞ is defined as area under the concentration vs. time curve from zero to infinity.
Terminal Elimination Half-life (T1/2)
Time frame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
T1/2 refers to the time taken for concentration of a drug to decrease from its maximum concentration to half of Cmax
2 secondary outcomes
Total Body Clearance (CL)
Time frame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Volume of Distribution (Vd)
Time frame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
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 18 May 2025.
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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 2 study testing Iron Sucrose injection 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 6 inclusion and 10 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 18 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Maximum Measured Plasma Concentration (Cmax) (time frame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes). The study lists 4 primary outcomes in all. 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 18 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.