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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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.

Country

City, postcode or hospital

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

Other trials in United States

Canada1 site

Investigative Site
Edmonton, Alberta, T6G2B7

Other trials in Canada

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.

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 groups in NCT00548249
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.

Aug 2007Jan 2010

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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.

Detailed description

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

Results posted to the registry on 8 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0 µg Iron/dL of Dialysate	26	10
5 µg Iron/dL of Dialysate	26	13
10 µg Iron/dL of Dialysate	29	9
12 µg Iron/dL of Dialysate	22	9
15 µg Iron/dL of Dialysate	28	7

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. Number. Unit: Percent of subjects

Measure	0 µg Iron/dL of Dialysate n = 26	5 µg Iron/dL of Dialysate n = 26	10 µg Iron/dL of Dialysate n = 29	12 µg Iron/dL of Dialysate n = 22	15 µg Iron/dL of Dialysate n = 28
Value	5	6 (0.30 to 3.32)	5 (0.33 to 4.09)	4 (0.21 to 3.02)	10 (0.60 to 5.19)

0 µg Iron/dL of Dialysate vs 5 µg Iron/dL of Dialysate: Cox Proportional Hazard: 1.00 (95% CI 0.30 to 3.32), p = 0.999, Log Rank
0 µg Iron/dL of Dialysate vs 10 µg Iron/dL of Dialysate: Cox Proportional Hazard: 1.17 (95% CI 0.33 to 4.09), p = 0.807, Log Rank
0 µg Iron/dL of Dialysate vs 12 µg Iron/dL of Dialysate: Cox Proportional Hazard: 0.80 (95% CI 0.21 to 3.02), p = 0.748, Log Rank

Population analysed: Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 26 weeks. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0 µg Iron/dL of Dialysate	7 of 26 (26.9%)	20 of 26 (76.9%)	Not reported
5 µg Iron/dL of Dialysate	2 of 26 (7.7%)	17 of 26 (65.4%)	Not reported
10 µg Iron/dL of Dialysate	5 of 29 (17.2%)	20 of 29 (69%)	Not reported
12 µg Iron/dL of Dialysate	7 of 22 (31.8%)	16 of 22 (72.7%)	Not reported
15 µg Iron/dL of Dialysate	5 of 28 (17.9%)	17 of 28 (60.7%)	Not reported

Limitations and caveats (from the sponsor): AE tabulation best summarizes the primary safety outcome. Lack of accuracy in analytical method for measuring iron concentration in inflow and outflow from dialysis machine impaired ability to assess secondary outcome of amount SFP transferred.

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?

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?

On the ClinicalTrials.gov record for NCT00548249.

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; AzTrials last refreshed its copy on 7 Nov 2026.