Kidney Failure, ChronicPhase 4NCT00354692
Effect of Two Iron Preparations on Protein in the Urine
A Phase 4 study testing Sodium Ferric Gluconate and Iron sucrose in people with Kidney Failure, Chronic and Anemia, Iron-Deficiency, run by Watson Pharmaceuticals at 2 sites in United States.
Trial summary
This pilot 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?
- Sodium Ferric Gluconate and Iron sucrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2006to Nov 2006
- 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
- Moderate to severe anemia
- Iron deficiency
- Moderate to severe chronic kidney disease
- Age ≥ 18 or greater and able to give informed consent
Who cannot join
- Receiving dialysis
- Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components
- Clinically unstable
- Indication of iron sufficiency
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Glendale, California
Study site
Shreveport, Louisiana
About this study
Official title: A Randomized Cross-over Pilot Study of the Effect of Sodium Ferric Gluconate Complex vs. Iron Sucrose on Proteinuria in Non-dialysis Chronic Kidney Disease Patients
This pilot 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
- Sodium Ferric Gluconate and Iron sucrose
- 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.
Sodium Ferric Gluconate and Iron sucroseDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Drug: Sodium Ferric Gluconate and Iron sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine protein
Measured: 180 minutes
Secondary outcomes (1)
Change in various urine chemicals
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionNov 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adel R. Rizkala, Pharm.D., MS, Study director, Watson Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354692
- Sponsor's protocol ID
- FER0601
- Status last verified
- Aug 2012
- First submitted
- 18 Jul 2006
- Last updated
- 14 Aug 2012
- Results posted
- No
Publications
Agarwal R, Rizkala AR, Kaskas MO, Minasian R, Trout JR. Iron sucrose causes greater proteinuria than ferric gluconate in non-dialysis chronic kidney disease. Kidney Int. 2007 Sep;72(5):638-42. doi: 10.1038/sj.ki.5002422. Epub 2007 Jul 11.
PubMed 17622274
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-over Pilot Study of the Effect of Sodium Ferric Gluconate Complex vs. Iron Sucrose on Proteinuria in Non-dialysis Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT00354692
- Acronym / sponsor ID
- FER0601
- Conditions
- Kidney Failure, Chronic, Anemia, Iron-Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Nov 2006 (actual)
- First posted
- 20 Jul 2006 (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 pilot 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Sodium Ferric Gluconate and Iron sucrose |
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
- Age ≥ 18 or greater and able to give informed consent
Key exclusion criteria (4 listed)
- Receiving dialysis
- Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components
- Clinically unstable
- Indication of iron sufficiency
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 |
|---|---|---|
| Sodium Ferric Gluconate and Iron sucrose | Drug | Experimental |
Primary outcome
Change in urine protein
Time frame: 180 minutes
1 secondary outcome
Change in various urine chemicals
Time frame: 180 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 14 Aug 2012.
- Results publication: PubMed 17622274Agarwal R, Rizkala AR, Kaskas MO, Minasian R, Trout JR. Iron sucrose causes greater proteinuria than ferric gluconate in non-dialysis chronic kidney disease. Kidney Int. 2007 Sep;72(5):638-42. doi: 10.1038/sj.ki.5002422. Epub 2007 Jul 11.
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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.
Adel R. Rizkala, Pharm.D., MS study director
Watson Laboratories, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Ferric Gluconate and Iron sucrose in people with Kidney Failure, Chronic and Anemia, Iron-Deficiency, run by Watson Pharmaceuticals at 2 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 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 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Change in urine protein (time frame: 180 minutes). 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 NCT00354692, 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 14 Aug 2012.