End-Stage Renal Disease (ESRD)Phase 2NCT00548249
Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis
A Phase 2 study testing Standard Bicarbonate Solution and Soluble Ferric Pyrophosphate in people with End-Stage Renal Disease (ESRD), run by Rockwell Medical Technologies, Inc. at 28 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during chronic hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease (ESRD)
- What is being tested?
- Standard Bicarbonate Solution and Soluble Ferric Pyrophosphate
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Aug 2007to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
None listed.
Who cannot join
- Hemoglobin (Hgb) values on two successive baseline/screening measurements that average ≥ 11.6g/dL
- Subject with a current malignancy involving a site other than skin
- Subject with a history of drug or alcohol abuse within the last six months
- Subject believed to be unable to complete the entire study (e.g., due to a concurrent disease, life expectancy of less than a year)
- Subject who the Principal Investigator considers will be placed at increased risk by the study procedures
- Subject requiring hemodialysis more than 3 times per week on a regular basis.
Show all 19Show fewer
- Subject who is unable to discontinue oral iron or intravenous iron supplements for the duration of the study
- Subject who is pregnant
- Subject considered incompetent to give an informed consent
- Subject with a positive test for Hepatitis B Surface Antigen within the past 30 days or during screening
- Subject with known HIV infection (if this is not known, no HIV testing will be performed)
- Subject with cirrhosis of the liver based on histological criteria or clinical criteria (presence of ascites, esophageal varices, spider nevi, or history of hepatic encephalopathy). Subject with hepatitis C, in the absence of cirrhosis, is not excluded from participation in the study if ALT and AST levels are below 2 times the upper limit of normal consistently during the 2 months preceding enrollment
- Subject with active tuberculosis, fungal, viral, or parasitic infection
- Subject with active bacterial infection requiring antibiotic therapy
- Subject with pre-dialysis Corrected Q-wave to T-wave (QTc) interval ≥ 470 milliseconds (ms)
- Subject with a history of hypokalemia, decompensated heart failure, or family history of Long QT Syndrome that in the Investigator's judgment poses a risk for Torsades de Pointe during the study
- Subject using concomitant medications known to prolong QT/QTc interval (See Appendix I, TABLE A)
- Subject receiving more than 60,000 units or 120 micrograms of erythropoietin (Epogen®, Procrit®, or Aranesp®) per week
- Subject has participated in another clinical trial within 30 days of signing Informed Consent
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States27 sites
Investigator
Arlington, Texas, 76011
Investigator
Arlington, Virginia, 22206
Investigative Site
Augusta, Georgia, 30901
Investigator
Brooklyn, New York, 11212
Investigative Site
Canton, Ohio, 44718
Investigator
Chicago, Illinois, 60617
Investigator
Cincinnati, Ohio, 45229
Investigative Site
Detroit, Michigan, 48202
Investigator
Fort Worth, Texas, 76105
Investigator
Great Neck, New York, 11021
Investigator
Hacienda Heights, California, 91745
Investigator
Hackensack, New Jersey, 07601
Investigative Site
Hershey, Pennsylvania, 17033
Investigator
Los Angeles, California, 90059
Investigative Site
Louisville, Kentucky, 40202-1718
Investigator
McAllen, Texas, 78503
Investigator
Meridian, Idaho, 83642
Investigator
Mineola, New York, 11501
Investigator
New Orleans, Louisiana, 70115
Investigator
New York, New York, 10013
Investigator
Ridgewood, New York, 11385
Investigator
San Antonio, Texas, 78207
Investigator
Seattle, Washington, 92133
Investigator
Springfield, Massachusetts, 01107
Investigator
Tempe, Arizona, 85284
Investigator
Whittier, California, 90603
Investigator
Winston-Salem, North Carolina, 27103
About this study
Official title: A Dose Ranging Study of Dialysate Containing Soluble Ferric Pyrophosphate (SFP) Versus Control in Subjects With ESRD Receiving Chronic Hemodialysis.
The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during chronic hemodialysis.
Read the detailed description
The study was designed to evaluate the efficacy of SFP-containing dialysate solution in maintaining physiological iron levels during chronic hemodialysis, as measured by the primary endpoint of the percent of patients whose Hemoglobin (Hgb) decreased by at least 1.0 gram/ deciliter (g/dL) from baseline. The efficacy and safety findings are to be used to determine the optimal concentration of SFP needed to safely maintain iron levels, compensating for iron losses during chronic hemodialysis.
- Conditions
- End-Stage Renal Disease (ESRD)
- Being tested
- Standard Bicarbonate Solution, Soluble Ferric Pyrophosphate
- Keywords
- Subjects with ESRD receiving chronic Hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Bicarbonate SolutionDevice
Also called Placebo
Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Soluble Ferric PyrophosphateDrug
Also called SFP
Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Soluble Ferric PyrophosphateDrug
Also called SFP
Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Soluble Ferric PyrophosphateDrug
Also called SFP
Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Soluble Ferric PyrophosphateDrug
Also called SFP
Patients received 15 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 0 µg iron/dL of dialysate | Placebo comparator | Placebo 0 micrograms (µg) of iron/ deciliter (dL) of dialysate Receives: Device: Standard Bicarbonate Solution |
| 5 µg iron/dL of dialysate | Experimental | 5 micrograms (µg) of iron/ deciliter (dL) of dialysate Receives: Drug: Soluble Ferric Pyrophosphate |
| 10 µg iron/dL of dialysate | Experimental | 10 micrograms (µg) of iron/ deciliter (dL) of dialysate Receives: Drug: Soluble Ferric Pyrophosphate |
| 12 µg iron/dL of dialysate | Experimental | 12 micrograms (µg) of iron/ deciliter (dL) of dialysate Receives: Drug: Soluble Ferric Pyrophosphate |
| 15 µg iron/dL of dialysate | Experimental | 15 micrograms (µg) of iron/ deciliter (dL) of dialysate Receives: Drug: Soluble Ferric Pyrophosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects Whose Hemoglobin (Hgb) Decreases by a Total of 1.0 Grams/ Deciliter (g/dL) (or More) From Baseline on Each of Two Successive Measurements.
Efficacy of a Soluble Ferric Pyrophosphate (SFP)-containing dialysate solution in maintaining physiological iron levels during chronic HD, as measured by the percent of subjects whose hgb decreases by a total of 1.0 g/dL (or more) from baseline on each of two successive measurements. Hemoglobin was obtained weekly at the mid-week dialysis treatments and compared to baseline value (average of two hgb measurements obtained at the two consecutive baseline visits prior to randomization).
Measured: up to 26 weeks
Secondary outcomes (5)
Change From Baseline in Hemoglobin (Hgb)
Measured: two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks)
Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group.
Kaplan-Meier Estimate of Time to First Hgb Decrease by >= 1.0 g/dL
Measured: Up to 26 weeks
Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
Efficacy of SFP administration in dialysate solution as measured by Chr values every four weeks, and at the end of the Subject's Treatment (up to 26 weeks).
Measured: Every 4 weeks
Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group.
Measured: At each dialysis session for up to 26 weeks
Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart.
Measured: two separate sessions measured one week apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End-Stage Renal Disease (ESRD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockwell Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Yocum, MD, Study director, Rockwell Medical Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548249
- Sponsor's protocol ID
- RMTI-SFP-2
- Status last verified
- Nov 2020
- First submitted
- 19 Oct 2007
- Last updated
- 2 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Ranging Study of Dialysate Containing Soluble Ferric Pyrophosphate (SFP) Versus Control in Subjects With ESRD Receiving Chronic Hemodialysis.
- ClinicalTrials.gov ID
- NCT00548249
- Acronym / sponsor ID
- RMTI-SFP-2
- Conditions
- End-Stage Renal Disease (ESRD)
- Keywords
- Subjects with ESRD receiving chronic Hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Rockwell Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 23 Oct 2007 (estimated)
- Results
- Posted 8 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during chronic hemodialysis.
Detailed description
The study was designed to evaluate the efficacy of SFP-containing dialysate solution in maintaining physiological iron levels during chronic hemodialysis, as measured by the primary endpoint of the percent of patients whose Hemoglobin (Hgb) decreased by at least 1.0 gram/ deciliter (g/dL) from baseline. The efficacy and safety findings are to be used to determine the optimal concentration of SFP needed to safely maintain iron levels, compensating for iron losses during chronic hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0 µg iron/dL of dialysate | Placebo comparator | Device: Standard Bicarbonate SolutionPlacebo 0 micrograms (µg) of iron/ deciliter (dL) of dialysate |
| 5 µg iron/dL of dialysate | Experimental | Drug: Soluble Ferric Pyrophosphate5 micrograms (µg) of iron/ deciliter (dL) of dialysate |
| 10 µg iron/dL of dialysate | Experimental | Drug: Soluble Ferric Pyrophosphate10 micrograms (µg) of iron/ deciliter (dL) of dialysate |
| 12 µg iron/dL of dialysate | Experimental | Drug: Soluble Ferric Pyrophosphate12 micrograms (µg) of iron/ deciliter (dL) of dialysate |
| 15 µg iron/dL of dialysate | Experimental | Drug: Soluble Ferric Pyrophosphate15 micrograms (µg) of iron/ deciliter (dL) of dialysate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (19 listed)
- Hemoglobin (Hgb) values on two successive baseline/screening measurements that average ≥ 11.6g/dL
- Subject with a current malignancy involving a site other than skin
- Subject with a history of drug or alcohol abuse within the last six months
- Subject believed to be unable to complete the entire study (e.g., due to a concurrent disease, life expectancy of less than a year)
- Subject who the Principal Investigator considers will be placed at increased risk by the study procedures
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 |
|---|---|---|
| Standard Bicarbonate SolutionAlso: PlaceboPatients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. | Device | 0 µg iron/dL of dialysate |
| Soluble Ferric PyrophosphateAlso: SFPPatients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. | Drug | 5 µg iron/dL of dialysate |
| Soluble Ferric PyrophosphateAlso: SFPPatients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. | Drug | 10 µg iron/dL of dialysate |
| Soluble Ferric PyrophosphateAlso: SFPPatients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. | Drug | 12 µg iron/dL of dialysate |
| Soluble Ferric PyrophosphateAlso: SFPPatients received 15 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. | Drug | 15 µg iron/dL of dialysate |
Primary outcome
Percent of Subjects Whose Hemoglobin (Hgb) Decreases by a Total of 1.0 Grams/ Deciliter (g/dL) (or More) From Baseline on Each of Two Successive Measurements.
Time frame: up to 26 weeks
Efficacy of a Soluble Ferric Pyrophosphate (SFP)-containing dialysate solution in maintaining physiological iron levels during chronic HD, as measured by the percent of subjects whose hgb decreases by a total of 1.0 g/dL (or more) from baseline on each of two successive measurements. Hemoglobin was obtained weekly at the mid-week dialysis treatments and compared to baseline value (average of two hgb measurements obtained at the two consecutive baseline visits prior to randomization).
5 secondary outcomes
Change From Baseline in Hemoglobin (Hgb)
Time frame: two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks)
Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group.
Time frame: Up to 26 weeks
Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
Time frame: Every 4 weeks
Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group.
Time frame: At each dialysis session for up to 26 weeks
Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart.
Time frame: two separate sessions measured one week apart.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard Yocum, MD study director
Rockwell Medical Technologies
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard Bicarbonate Solution and Soluble Ferric Pyrophosphate in people with End-Stage Renal Disease (ESRD), run by Rockwell Medical Technologies, Inc. at 28 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 0 inclusion and 19 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 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Subjects Whose Hemoglobin (Hgb) Decreases by a Total of 1.0 Grams/ Deciliter (g/dL) (or More) From Baseline on Each of Two Successive Measurements. (time frame: up to 26 weeks). 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 2 Dec 2020.