Anemia, Iron-DeficiencyPhase 4DRIVENCT00224081
DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)
A Phase 4 study testing Sodium ferric gluconate, in people with Anemia, Iron-Deficiency and Kidney Failure, Chronic, run by Watson Pharmaceuticals at 29 sites in United States.
Trial summary
This study explores the safety and efficacy of intravenous iron therapy in anemic hemodialysis patients treated with epoetin alfa, who have higher serum ferritin levels, but low to normal transferrin saturation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Iron-Deficiency, Kidney Failure, Chronic, Hemodialysis
- What is being tested?
- Sodium ferric gluconate,
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 29 sitesUnited States
- Study dates
- Sep 2004to May 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
- Chronic hemodialysis
- Elevated serum ferritin with low to normal transferrin saturation (TSAT)
- Moderate to severe anemia
- Receiving epoetin alfa treatment
Who cannot join
- Known sensitivity to Ferrlecit®
- Medical conditions that would confound the efficacy evaluation
- Recent blood transfusion
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Study site
Arlington, Texas
Study site
Bakersfield, California
Study site
Boston, Massachusetts
Study site
Brooklyn, New York
Study site
Chattanooga, Tennessee
Study site
Columbia, Missouri
Study site
Crestwood, Illinois
Study site
Glendale, California
Study site
Houston, Texas
Study site
Kalamazoo, Michigan
Study site
Knoxville, Tennessee
Study site
Lauderdale Lakes, Florida
Study site
Los Angeles, California
Study site
Minneola, New York
Study site
Morgantown, West Virginia
Study site
New York, New York
Study site
North Brunswick, New Jersey
Study site
Philadelphia, Pennsylvania
Study site
Roswell, Georgia
Study site
Royal Oak, Michigan
Study site
San Antonio, Texas
Study site
Santa Rosa, California
Study site
Shreveport, Louisiana
Study site
St Louis, Missouri
Study site
Tampa, Florida
Study site
Torrance, California
Study site
Waycross, Georgia
Study site
Wichita, Kansas
Study site
Youngstown, Ohio
About this study
Official title: Dialysis Patients' Response to IV Iron With Elevated Ferritin
This study explores the safety and efficacy of intravenous iron therapy in anemic hemodialysis patients treated with epoetin alfa, who have higher serum ferritin levels, but low to normal transferrin saturation.
- Being tested
- Sodium ferric gluconate,
- Keywords
- iron deficiency anemia, ferritin, hemodialysis, sodium ferric gluconate, epoetin alfa
- Medical subject headings
- Anemia, Iron-Deficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium ferric gluconate,Drug
Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions
| Study group | Role | What they receive |
|---|---|---|
| Ferric gluconate | Experimental | Not described Receives: Drug: Sodium ferric gluconate, |
| standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin and anemia medications
Measured: 6 weeks
Secondary outcomes (1)
Change in various iron indices
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 posted22 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron-DeficiencyStudies 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
- 134 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
- NCT00224081
- Sponsor's protocol ID
- FER0401
- Acronym
- DRIVE
- Status last verified
- Dec 2015
- First submitted
- 13 Sep 2005
- Last updated
- 10 Dec 2015
- Results posted
- No
Publications
Coyne DW, Kapoian T, Suki W, Singh AK, Moran JE, Dahl NV, Rizkala AR; DRIVE Study Group. Ferric gluconate is highly efficacious in anemic hemodialysis patients with high serum ferritin and low transferrin saturation: results of the Dialysis Patients' Response to IV Iron with Elevated Ferritin (DRIVE) Study. J Am Soc Nephrol. 2007 Mar;18(3):975-84. doi: 10.1681/ASN.2006091034. Epub 2007 Jan 31.
PubMed 17267740Singh AK, Coyne DW, Shapiro W, Rizkala AR; DRIVE Study Group. Predictors of the response to treatment in anemic hemodialysis patients with high serum ferritin and low transferrin saturation. Kidney Int. 2007 Jun;71(11):1163-71. doi: 10.1038/sj.ki.5002223. Epub 2007 Mar 28.
PubMed 17396118Kapoian T, O'Mara NB, Singh AK, Moran J, Rizkala AR, Geronemus R, Kopelman RC, Dahl NV, Coyne DW. Ferric gluconate reduces epoetin requirements in hemodialysis patients with elevated ferritin. J Am Soc Nephrol. 2008 Feb;19(2):372-9. doi: 10.1681/ASN.2007050606. Epub 2008 Jan 23.
PubMed 18216316Pizzi LT, Bunz TJ, Coyne DW, Goldfarb DS, Singh AK. Ferric gluconate treatment provides cost savings in patients with high ferritin and low transferrin saturation. Kidney Int. 2008 Dec;74(12):1588-95. doi: 10.1038/ki.2008.489. Epub 2008 Oct 1.
PubMed 19034302
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialysis Patients' Response to IV Iron With Elevated Ferritin
- ClinicalTrials.gov ID
- NCT00224081
- Acronym / sponsor ID
- DRIVE / FER0401
- Keywords
- iron deficiency anemia, ferritin, hemodialysis, sodium ferric gluconate, epoetin alfa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- May 2006 (actual)
- First posted
- 22 Sep 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 study explores the safety and efficacy of intravenous iron therapy in anemic hemodialysis patients treated with epoetin alfa, who have higher serum ferritin levels, but low to normal transferrin saturation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric gluconate | Experimental | Drug: Sodium ferric gluconate, |
| standard of care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic hemodialysis
- Elevated serum ferritin with low to normal transferrin saturation (TSAT)
- Moderate to severe anemia
- Receiving epoetin alfa treatment
Key exclusion criteria (3 listed)
- Known sensitivity to Ferrlecit®
- Medical conditions that would confound the efficacy evaluation
- Recent blood transfusion
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,Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions | Drug | Ferric gluconate |
Primary outcome
Change in hemoglobin and anemia medications
Time frame: 6 weeks
1 secondary outcome
Change in various iron indices
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 10 Dec 2015.
- Results publication: PubMed 17267740Coyne DW, Kapoian T, Suki W, Singh AK, Moran JE, Dahl NV, Rizkala AR; DRIVE Study Group. Ferric gluconate is highly efficacious in anemic hemodialysis patients with high serum ferritin and low transferrin saturation: results of the Dialysis Patients' Response to IV Iron with Elevated Ferritin (DRIVE) Study. J Am Soc Nephrol. 2007 Mar;18(3):975-84. doi: 10.1681/ASN.2006091034. Epub 2007 Jan 31.
- Results publication: PubMed 17396118Singh AK, Coyne DW, Shapiro W, Rizkala AR; DRIVE Study Group. Predictors of the response to treatment in anemic hemodialysis patients with high serum ferritin and low transferrin saturation. Kidney Int. 2007 Jun;71(11):1163-71. doi: 10.1038/sj.ki.5002223. Epub 2007 Mar 28.
- Results publication: PubMed 18216316Kapoian T, O'Mara NB, Singh AK, Moran J, Rizkala AR, Geronemus R, Kopelman RC, Dahl NV, Coyne DW. Ferric gluconate reduces epoetin requirements in hemodialysis patients with elevated ferritin. J Am Soc Nephrol. 2008 Feb;19(2):372-9. doi: 10.1681/ASN.2007050606. Epub 2008 Jan 23.
- Results publication: PubMed 19034302Pizzi LT, Bunz TJ, Coyne DW, Goldfarb DS, Singh AK. Ferric gluconate treatment provides cost savings in patients with high ferritin and low transferrin saturation. Kidney Int. 2008 Dec;74(12):1588-95. doi: 10.1038/ki.2008.489. Epub 2008 Oct 1.
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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.
29 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, in people with Anemia, Iron-Deficiency and Kidney Failure, Chronic, run by Watson Pharmaceuticals at 29 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 3 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 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 hemoglobin and anemia medications (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 NCT00224081, which also lists 4 linked publications.
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 10 Dec 2015.