HemodialysisPhase 4NCT06690450
Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis(HD) Patients
A Phase 4 study testing Venofer® 200 mg and Venofer® 100 mg in people with Hemodialysis, run by American Regent, Inc..
Trial summary
The Objective of this study is to assess the Safety and Tolerability of 200 mg and 100 mg of Venofer Administered to Hemodialysis(HD) Patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Venofer® 200 mg and Venofer® 100 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Aug 2001to Feb 2002
- Phase
- Phase 4
- 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
- Males or females over 18 years of age and able to give informed consent.
- Undergoing hemodialysis.
- If receiving epoetin α, then the dose was stable.
- Percentage serum transferrin saturation (TSAT) <50% and serum ferritin <800 ng/mL.
- Absence of infection, malignancy, or surgery in the month prior to study start.
- Intolerance of other iron products did not preclude participation in this study.
Who cannot join
- Known sensitivity to any component of Venofer®.
- Suffering from concomitant severe diseases of the liver, cardiovascular system, severe psychiatric disorders or other conditions which, in the opinion of the investigator, made participation unacceptable.
- Serious bacterial, viral infection, or other acute infectious illness (e.g., hepatitis) unless completely resolved at least 4 weeks prior to inclusion in the study.
- Pregnancy or lactation.
- HIV positive by medical history or laboratory test (optional), or active hepatitis.
- Anemia caused by diseases (including systemic lupus erythematosus (SLE), rheumatoid arthritis, myeloma, or hereditary hemoglobinopathies) other than chronic renal failure or iron deficiency.
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- Asthma.
- Clinical evidence of gastrointestinal bleeding.
- Would probably require blood transfusion or might undergo a renal transplant during the study.
- Anticipated surgery of any kind during the study other than vascular access surgery.
- Received an investigational drug within 30 days prior to screening.
- Previously participated in another Venofer® study.
About this study
Official title: A Randomized Study to Assess the Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis (HD) Patients
The Objective of this study is to assess the Safety and Tolerability of 200 mg and 100 mg of Venofer Administered to Hemodialysis(HD) Patients.
Read the detailed description
This is a randomized open label multi-center study of two parallel patient groups undergoing hemodialysis. Group A will receive 200 mg of iron sucrose, while Group B will receive 100 mg of iron sucrose during the study. The duration of the study for each patient will be approximately 3 weeks including a screening phase, a treatment visit and a follow-up visit.
- Conditions
- Hemodialysis
- Being tested
- Venofer® 200 mg, Venofer® 100 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venofer® 200 mgDrug
Also called Iron sucrose
A single 200 mg dose of Venofer® administered by slow intravenous push over 5 minutes
Venofer® 100 mgDrug
Also called Iron sucrose
A single 100 mg dose of Venofer® administered by slow intravenous push over 2 minutes without a test dose.
| Study group | Role | What they receive |
|---|---|---|
| Venofer® 200 mg | Experimental | A single 200 mg dose of Venofer® administered by slow intravenous push over 5 minutes. Receives: Drug: Venofer® 200 mg |
| Venofer® 100 mg | Active comparator | A single 100 mg dose of Venofer® administered by slow intravenous push over 2 minutes without a test dose Receives: Drug: Venofer® 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.0
Any untoward medical events were elicited by nonspecific questions such as "Have you noticed any problems".
Measured: 3 to 6 days
Secondary outcomes (1)
The number of participants prematurely discontinued the study due to an adverse event
The investigator determined whether any adverse event warranted removal of a subject from the study
Measured: 3 to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study startAug 2001
- Primary completionJan 2002
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carol Duffy, D.O.,FACC, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690450
- Sponsor's protocol ID
- 1VEN01015
- Status last verified
- Nov 2024
- First submitted
- 7 Feb 2019
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Assess the Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis (HD) Patients
- ClinicalTrials.gov ID
- NCT06690450
- Acronym / sponsor ID
- 1VEN01015
- Conditions
- Hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2001 (actual)
- Primary completion
- Jan 2002 (actual)
- Study completion
- Feb 2002 (actual)
- First posted
- 15 Nov 2024 (actual)
- 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 Objective of this study is to assess the Safety and Tolerability of 200 mg and 100 mg of Venofer Administered to Hemodialysis(HD) Patients.
Detailed description
This is a randomized open label multi-center study of two parallel patient groups undergoing hemodialysis. Group A will receive 200 mg of iron sucrose, while Group B will receive 100 mg of iron sucrose during the study. The duration of the study for each patient will be approximately 3 weeks including a screening phase, a treatment visit and a follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venofer® 200 mg | Experimental | Drug: Venofer® 200 mgA single 200 mg dose of Venofer® administered by slow intravenous push over 5 minutes. |
| Venofer® 100 mg | Active comparator | Drug: Venofer® 100 mgA single 100 mg dose of Venofer® administered by slow intravenous push over 2 minutes without a test dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females over 18 years of age and able to give informed consent.
- Undergoing hemodialysis.
- If receiving epoetin α, then the dose was stable.
- Percentage serum transferrin saturation (TSAT) <50% and serum ferritin <800 ng/mL.
- Absence of infection, malignancy, or surgery in the month prior to study start.
Key exclusion criteria (12 listed)
- Known sensitivity to any component of Venofer®.
- Suffering from concomitant severe diseases of the liver, cardiovascular system, severe psychiatric disorders or other conditions which, in the opinion of the investigator, made participation unacceptable.
- Serious bacterial, viral infection, or other acute infectious illness (e.g., hepatitis) unless completely resolved at least 4 weeks prior to inclusion in the study.
- Pregnancy or lactation.
- HIV positive by medical history or laboratory test (optional), or 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 |
|---|---|---|
| Venofer® 200 mgAlso: Iron sucroseA single 200 mg dose of Venofer® administered by slow intravenous push over 5 minutes | Drug | Venofer® 200 mg |
| Venofer® 100 mgAlso: Iron sucroseA single 100 mg dose of Venofer® administered by slow intravenous push over 2 minutes without a test dose. | Drug | Venofer® 100 mg |
Primary outcome
The number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.0
Time frame: 3 to 6 days
Any untoward medical events were elicited by nonspecific questions such as "Have you noticed any problems".
1 secondary outcome
The number of participants prematurely discontinued the study due to an adverse event
Time frame: 3 to 6 days
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 15 Nov 2024.
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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.
Carol Duffy, D.O.,FACC study director
Medical Director
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Venofer® 200 mg and Venofer® 100 mg in people with Hemodialysis, 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 12 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 15 Nov 2024. 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 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?
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?
The number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.0 (time frame: 3 to 6 days). 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 15 Nov 2024.