Kidney Failure, ChronicPhase 1NCT00534144
Comparison Between Effects of Two Iron Preparations on Protein in the Urine
A Phase 1 study testing iron sucrose injection, USP and sodium ferric gluconate complex in sucrose injection in people with Kidney Failure, Chronic and Anemia, Iron-Deficiency, run by Watson Pharmaceuticals at 13 sites in 2 countries.
Trial summary
This study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Anemia, Iron-Deficiency
- What is being tested?
- iron sucrose injection, USP and sodium ferric gluconate complex in sucrose injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Sep 2007to Nov 2008
- Phase
- Phase 1
- 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
- Moderate to severe anemia
- Iron deficiency
- Moderate to severe chronic kidney disease, not receiving dialysis
- Age ≥ 18 or greater and able to give informed consent
Who cannot join
- Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components
- Clinically unstable
- Indication of iron sufficiency
- Bladder obstruction conditions that would not allow for good urine output
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Study site
Alhambra, California
Study site
Bell Gardens, California
Study site
Boston, Massachusetts
Study site
Exeter, California
Study site
Fairfax, Virginia
Study site
Fort Lauderdale, Florida
Study site
Glendale, California
Study site
Hines, Illinois
Study site
Houston, Texas
Study site
Phoenix, Arizona
Study site
Shreveport, Louisiana
Study site
Visalia, California
About this study
Official title: A Randomized Controlled Trial of the Effect of IV Iron on Proteinuria in Non-Dialysis Chronic Kidney Disease Patients
This study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein
- Conditions
- Kidney Failure, Chronic, Anemia, Iron-Deficiency
- Being tested
- iron sucrose injection, USP, sodium ferric gluconate complex in sucrose injection
- Medical subject headings
- Kidney Failure, Chronic, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron sucrose injection, USPDrug
iron sucrose injection, USP, 100 mg intravenously (IV) per week, for 5 weeks
sodium ferric gluconate complex in sucrose injectionDrug
sodium ferric gluconate complex in sucrose injection, 100 mg intravenously (IV) per week, for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Iron Sucrose | Active comparator | Not described Receives: Drug: iron sucrose injection, USP |
| Ferric Gluconate | Active comparator | Not described Receives: Drug: sodium ferric gluconate complex in sucrose injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine protein
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naomi V. Dahl, Pharm.D., Study director, Watson Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534144
- Sponsor's protocol ID
- FER0701
- Status last verified
- Sep 2011
- First submitted
- 20 Sep 2007
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Agarwal R, Leehey DJ, Olsen SM, Dahl NV. Proteinuria induced by parenteral iron in chronic kidney disease--a comparative randomized controlled trial. Clin J Am Soc Nephrol. 2011 Jan;6(1):114-21. doi: 10.2215/CJN.06020710. Epub 2010 Sep 28.
PubMed 20876669
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effect of IV Iron on Proteinuria in Non-Dialysis Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT00534144
- Acronym / sponsor ID
- FER0701
- Conditions
- Kidney Failure, Chronic, Anemia, Iron-Deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 24 Sep 2007 (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 study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron Sucrose | Active comparator | Drug: iron sucrose injection, USP |
| Ferric Gluconate | Active comparator | Drug: sodium ferric gluconate complex in sucrose injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate to severe anemia
- Iron deficiency
- Moderate to severe chronic kidney disease, not receiving dialysis
- Age ≥ 18 or greater and able to give informed consent
Key exclusion criteria (4 listed)
- Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components
- Clinically unstable
- Indication of iron sufficiency
- Bladder obstruction conditions that would not allow for good urine output
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 injection, USPiron sucrose injection, USP, 100 mg intravenously (IV) per week, for 5 weeks | Drug | Iron Sucrose |
| sodium ferric gluconate complex in sucrose injectionsodium ferric gluconate complex in sucrose injection, 100 mg intravenously (IV) per week, for 5 weeks | Drug | Ferric Gluconate |
Primary outcome
Change in urine protein
Time frame: 6 weeks
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 23 Sep 2011.
- Results publication: PubMed 20876669Agarwal R, Leehey DJ, Olsen SM, Dahl NV. Proteinuria induced by parenteral iron in chronic kidney disease--a comparative randomized controlled trial. Clin J Am Soc Nephrol. 2011 Jan;6(1):114-21. doi: 10.2215/CJN.06020710. Epub 2010 Sep 28.
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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.
Naomi V. Dahl, Pharm.D. study director
Watson Laboratories, Inc.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing iron sucrose injection, USP and sodium ferric gluconate complex in sucrose injection in people with Kidney Failure, Chronic and Anemia, Iron-Deficiency, run by Watson Pharmaceuticals at 13 sites in 2 countries.
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 4 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 23 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Puerto Rico. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in urine protein (time frame: 6 weeks). 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 NCT00534144, 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 23 Sep 2011.