Chronic Kidney DiseaseNCT02492672
Registry to Evaluate Maintenance Treatment With Venofer in Pediatric Patients With Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by American Regent, Inc. at 9 sites in United States.
Trial summary
The current registry is being undertaken to assess the long-term (12 month) safety and tolerability of Venofer in the pediatric population with chronic kidney disease that requires intravenous iron maintenance therapy. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 50 participants
- Where
- 9 sitesUnited States
- Study dates
- Sep 2014to Dec 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The current registry is being undertaken to assess the long-term (12 month) safety and tolerability of Venofer in the pediatric population with chronic kidney disease (CKD) that requries intravenous iron maintenance therapy.
Who may be able to join
- Age greater than or equal to 2 to less than or equal to 17 years
- Subjects must have a diagnosis of either NDD-CKD, PD-CKD or HD-CKD
- Dialysis patients must be on a stable periotoneal (PD) or hemodialysis (HD) regimen for 1 month
- Patient agrees to participate in the registry (i.e., provide adverse event information) for 12 months
Who cannot join
- -
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Johns Hopkins Medicine
Baltimore, Maryland, 21205
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
East Carolina University
Greenville, North Carolina, 27834
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Iowa
Iowa City, Iowa, 52242
Nemours Orlando A.I. DuPont Hospital for Children
Jacksonville, Florida, 32256
University of Miami
Miami, Florida, 33101
Stanford University
Palo Alto, California, 94306
About this study
Official title: A Multicenter Registry to Evaluate the Long-term Safety and Tolerability of Maintenance Treatment With Iron Sucrose (Venofer) in Pediatric Patients Ages ≥ 2 to ≤ 17 Years With Chronic Kidney Disease
The current registry is being undertaken to assess the long-term (12 month) safety and tolerability of Venofer in the pediatric population with chronic kidney disease that requires intravenous iron maintenance therapy.
Read the detailed description
This will be a multicenter, observational, prospective registry collecting long-term (12-month) safety, tolerability, and laboratory data. Subjects will be screened for inclusion criteria if on hemodialysis (HD), peritoneal dialysis (PD) or have non-dialysis dependent (NDD) chronic kidney disease (CKD).
Treatment-emergent adverse events (adverse events starting from the time of the 1st dose of Venofer administered on study) will be collected via site entry of data into a web-based system. Each research investigator will be responsible for entering adverse event information on the appropriate clinical research form as well as reporting such events to the sponsor.
Number of Subjects: 50 evaluable subjects (i.e., took at lease one dose of Venofer and have safety data recorded at the 12 month time point).
- Conditions
- Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment- emergent adverse events (TEAE)
Adverse Events starting from from the 1st dose of Venofer adminstered on study through 12 month observation
Measured: 1st Venofer dose through 12 month observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionNov 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda M. Mundy, MD, PhD, Study director, American Regent, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492672
- Sponsor's protocol ID
- Registry Protocol
- Status last verified
- Jun 2019
- First submitted
- 6 Jul 2015
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Registry to Evaluate the Long-term Safety and Tolerability of Maintenance Treatment With Iron Sucrose (Venofer) in Pediatric Patients Ages ≥ 2 to ≤ 17 Years With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02492672
- Acronym / sponsor ID
- Registry Protocol
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Nov 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 9 Jul 2015 (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.
The current registry is being undertaken to assess the long-term (12 month) safety and tolerability of Venofer in the pediatric population with chronic kidney disease that requires intravenous iron maintenance therapy.
Detailed description
This will be a multicenter, observational, prospective registry collecting long-term (12-month) safety, tolerability, and laboratory data. Subjects will be screened for inclusion criteria if on hemodialysis (HD), peritoneal dialysis (PD) or have non-dialysis dependent (NDD) chronic kidney disease (CKD).
Treatment-emergent adverse events (adverse events starting from the time of the 1st dose of Venofer administered on study) will be collected via site entry of data into a web-based system. Each research investigator will be responsible for entering adverse event information on the appropriate clinical research form as well as reporting such events to the sponsor.
Number of Subjects: 50 evaluable subjects (i.e., took at lease one dose of Venofer and have safety data recorded at the 12 month time point).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The current registry is being undertaken to assess the long-term (12 month) safety and tolerability of Venofer in the pediatric population with chronic kidney disease (CKD) that requries intravenous iron maintenance therapy.
Key inclusion criteria (4 listed)
- Age greater than or equal to 2 to less than or equal to 17 years
- Subjects must have a diagnosis of either NDD-CKD, PD-CKD or HD-CKD
- Dialysis patients must be on a stable periotoneal (PD) or hemodialysis (HD) regimen for 1 month
- Patient agrees to participate in the registry (i.e., provide adverse event information) for 12 months
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment- emergent adverse events (TEAE)
Time frame: 1st Venofer dose through 12 month observation
Adverse Events starting from from the 1st dose of Venofer adminstered on study through 12 month observation
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 19 Jun 2019.
- Individual participant dataSharing planned: Yes
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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.
Linda M. Mundy, MD, PhD study director
American Regent, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by American Regent, Inc. at 9 sites 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 4 inclusion and 1 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 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
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?
Treatment- emergent adverse events (TEAE) (time frame: 1st Venofer dose through 12 month observation). 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 19 Jun 2019.