End Stage Renal Disease (ESRD)NCT00604565

Delivery of Soluble Ferric Pyrophosphate (SFP) Via the Dialysate to Maintain Iron Balance in Hemodialysis Patients

A study testing soluble ferric pyrophosphate (SFP) in people with End Stage Renal Disease (ESRD), run by Charles Drew University of Medicine and Science at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

In maintenance hemodialysis patients, regular administration of parenteral iron by addition of soluble ferric pyrophosphate (SFP) to the dialysate, when compared to conventional dialysate, is effective in preventing the development of iron deficiency, thereby maintaining hemoglobin level; is clinically safe and does… 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?: soluble ferric pyrophosphate (SFP)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 2 sitesUnited States
Study dates: Jan 2008to Dec 2010
Phase: Interventional
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

Subjects with absolute iron deficiency at the time of enrollment In hemodialysis subjects "absolute iron deficiency"
Subjects with a current malignancy involving sites other than skin.
Subjects with a history of drug or alcohol abuse within the last 6 months

Trial locations and contacts

2 sites in 1 country.

United States2 sites

RAI
Los Angeles, California, 90059
University of Louisville Kidney Disease Program
Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: A Prospective, Randomized, Open-label, Multi-center, Controlled Clinical Trial of the Safety and Efficacy of Physiological Iron Maintenance in End Stage Renal Disease (ESRD) Subjects by Delivery of Soluble Ferric Pyrophosphate (SFP) Via Hemodialysate

Conditions: End Stage Renal Disease (ESRD)
Being tested: soluble ferric pyrophosphate (SFP), placebo
Keywords: 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.

soluble ferric pyrophosphate (SFP)Drug
Subjects will be randomized to undergo dialysis with either Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL).
Control concentrate lacking SFP (C-HD) does not contain SFP (total iron = 0)
placeboOther
Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)

Study groups in NCT00604565
Study group	Role	What they receive
SFP dialysate	Experimental	dialysate with added soluble ferric pyrophosphate (SFP) Receives: Drug: soluble ferric pyrophosphate (SFP)
standard dialysate	Placebo comparator	standard dialysate without soluble ferric pyrophosphate (SFP) Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS
Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of subjects affected are listed only. The details of the types of events that took place are reported in the Adverse Events section.
Measured: 36 weeks
TOTAL NUMBER OF ADVERSE EVENTS
Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of events are listed only. The details of the types of events that took place are reported in the Adverse Events section.
Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Dec 2010

First posted30 Jan 2008 (estimated)
Study startJan 2008
Primary completionDec 2010
Study completionDec 2010

Why it stopped: major planned changes to study design

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 N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00604565
Sponsor's protocol ID: SFP-NIH-01
Other IDs: NIH-FP-01
Status last verified: Aug 2015
First submitted: 17 Jan 2008
Last updated: 31 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Open-label, Multi-center, Controlled Clinical Trial of the Safety and Efficacy of Physiological Iron Maintenance in End Stage Renal Disease (ESRD) Subjects by Delivery of Soluble Ferric Pyrophosphate (SFP) Via Hemodialysate
ClinicalTrials.gov ID: NCT00604565
Acronym / sponsor ID: SFP-NIH-01
Conditions: End Stage Renal Disease (ESRD)
Keywords: Hemodialysis
Study type: Interventional
Recruitment status: TerminatedReason stopped: major planned changes to study design
Enrolment: 11 participants (actual)
Lead sponsor: Charles Drew University of Medicine and ScienceUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), Rockwell Medical Technologies, Inc.
Study start: Jan 2008
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 30 Jan 2008 (estimated)
Results: Posted 31 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
SFP dialysate	Experimental	Drug: soluble ferric pyrophosphate (SFP)dialysate with added soluble ferric pyrophosphate (SFP)
standard dialysate	Placebo comparator	Other: placebostandard dialysate without soluble ferric pyrophosphate (SFP)

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 (3 listed)

Subjects with absolute iron deficiency at the time of enrollment In hemodialysis subjects "absolute iron deficiency"
Subjects with a current malignancy involving sites other than skin.
Subjects with a history of drug or alcohol abuse within the last 6 months

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
soluble ferric pyrophosphate (SFP)Subjects will be randomized to undergo dialysis with either Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL). Control concentrate lacking SFP (C-HD) does not contain SFP (total iron = 0)	Drug	SFP dialysate
placeboSubjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)	Other	standard dialysate

Primary outcome

TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS
Time frame: 36 weeks
Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of subjects affected are listed only. The details of the types of events that took place are reported in the Adverse Events section.
TOTAL NUMBER OF ADVERSE EVENTS
Time frame: 36 weeks
Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of events are listed only. The details of the types of events that took place are reported in the Adverse Events section.

Results and safety

Results posted to the registry on 31 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SFP Dialysate	4	4
Standard Dialysate	7	4

Primary outcome: TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS

Time frame: 36 weeks. Number. Unit: participants

Measure	SFP Dialysate n = 4	Standard Dialysate n = 7
Number of Subjects Who Experienced Serious AE	0	1
Number of Subjects Who Experienced Non-serious AE	4	7

Population analysed: All subjects were included in the Safety Analysis population.

Primary outcome: TOTAL NUMBER OF ADVERSE EVENTS

Time frame: 36 weeks. Number. Unit: events

Measure	SFP Dialysate n = 4	Standard Dialysate n = 7
Total Number of Serious Adverse Events (SAEs)	0	1
Total Number of Non-Serious Adverse Events	66	115

Population analysed: All subjects were included in the Safety Analysis population.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SFP Dialysate	0 of 4 (0%)	4 of 4 (100%)	Not reported
Standard Dialysate	1 of 7 (14.3%)	7 of 7 (100%)	Not reported

Limitations and caveats (from the sponsor): Study suspended after 1st 11 subjects enrolled. Study design changed significantly upon re-initiation, so 1st 11 subjects analyzed for safety only; no efficacy. Efficacy analysis from study after re-initiation is found under protocol NIH-FP-01 PRIME.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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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.

Ajay Gupta, MD principal investigator

Rockwell Medical Technologies, Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing soluble ferric pyrophosphate (SFP) in people with End Stage Renal Disease (ESRD), run by Charles Drew University of Medicine and Science 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 0 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: stopped early, as of the sponsor's last update on 31 Aug 2015. 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. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2015). 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?

TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS (time frame: 36 weeks). The study lists 2 primary outcomes in all. 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 NCT00604565.

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 31 Aug 2015.