End Stage Renal DiseasePhase 3NCT01503021
Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis
A Phase 3 study testing SFP in people with End Stage Renal Disease and Chronic Kidney Disease, run by Rockwell Medical Technologies, Inc. at 31 sites in 2 countries.
Trial summary
The purpose of the parent study is to assess the short-term safety and tolerability of soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of representative adult chronic kidney disease patients on hemodialysis (CKD-HD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Chronic Kidney Disease
- What is being tested?
- SFP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 718 participants
- Where
- 31 sitesin 2 countries
- Study dates
- Nov 2011to Jan 2014
- Phase
- Phase 3
- 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
- Adult ≥ 18 years of age.
- Has chronic kidney disease (CKD) receiving maintenance hemodialysis (HD) (CKD-HD subjects) and regularly undergoing 2 or more dialysis sessions per week.
- Stable pre-dialysis Hgb ≥ 9.0 to ≤ 12.5 g/dL.
- Stable pre-dialysis TSAT ≥ 15% to ≤ 45%.
- Stable pre-dialysis ferritin ≥ 100 to ≤ 1200 µg/L (1200 ng/mL).
- Participated in Parent Study RMTI-SFP-6 and completed the follow-up/early term visit.
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- Hemoglobin ≤12.0 g/dL at screening.
- TSAT ≤45% at screening. (Excursion of TSAT by ≤10% outside this range permitted only if all other inclusion/exclusion criteria are met).
- Serum ferritin ≤1000 µg/L at screening. (Excursion of ferritin by ≤10% outside this range permitted only if all other inclusion/exclusion criteria are met).
Who cannot join
- Any previous exposure to SFP.
- Therapy with intravenous, intramuscular or oral iron at any time between the first/screening visit and the randomization visit, or anticipated requirement for iron supplementation during the study period.
- Non-tunneled vascular catheter for dialysis.
- Scheduled for kidney transplant within the next 8 weeks.
- Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to screening, or during screening period prior to randomization.
- Hospitalization within 1 month prior to screening (except for vascular access surgery).
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- Extension Study, Open Label, Single Active Arm:
- Had a serious adverse event attributable (i.e., probably, possibly, or definitely related) to study drug or had an adverse event attributable to study drug that necessitated premature withdrawal from the double-blind, placebo-controlled crossover phase of the parent study RMTI-SFP-6.
- Non-tunneled vascular catheter for dialysis.
- Scheduled for kidney transplant within 12 weeks after entry into extension phase.
- Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to dosing.
- Pregnancy or intention to become pregnant during the study.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States28 sites
Study site
Arvada, Colorado, 80002
Study site
Baton Rouge, Louisiana, 70808
Study site
Camp Springs, Maryland, 20748
Study site
Chicago, Illinois, 60616
Study site
City of Saint Peters, Missouri, 63376
Study site
Columbia, South Carolina, 29209
Study site
Columbus, Indiana, 47201
Study site
Dayton, Ohio, 45428
Study site
Gulfport, Mississippi, 39501
Research Across America
Houston, Texas, 75234
Study site
Houston, Texas, 77051
Study site
Irving, Texas, 75061
Study site
Lauderhill, Florida, 33319
Study site
Lincoln, Nebraska, 68510
Study site
Marietta, Georgia, 30060
Study site
McComb, Mississippi, 39648
Study site
Mission, Texas, 78572
Study site
Mobile, Alabama, 36688
Study site
Northridge, California, 91324
Study site
Peoria, Illinois, 61603
Study site
Reno, Nevada, 89511
Study site
Rocky Mount, North Carolina, 27804
Study site
Shreveport, Louisiana, 71101
Study site
Temple, Texas, 76508
Study site
Tupelo, Mississippi, 38801
Study site
Tyler, Texas, 75701
Study site
Westminster, Colorado, 80031
Study site
Wichita, Kansas, 67214
Canada3 sites
Study site
Courtice, Ontario, L1E 3C3
Study site
Montreal, Quebec, H3A 1A1
Study site
Regina, Saskatchewan, 54P 0W5
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Crossover, Multicenter Phase III Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in Chronic Kidney Disease Patients Receiving Chronic Hemodialysis
The purpose of the parent study is to assess the short-term safety and tolerability of soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of representative adult chronic kidney disease patients on hemodialysis (CKD-HD).
The purpose of the extension study is to assess the long-term safety and tolerability of SFP.
Read the detailed description
Parent Study: randomized, double-blinded, crossover, up to 6 weeks, 700 patients. Patients were randomized to receive SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate or placebo (standard liquid bicarbonate concentrate) x 2 weeks, then a 1 week washout, then crossed over to the alternate treatment x 2 weeks.
Extension Study: open-label, single active arm, uncontrolled study, up to 53 weeks, 300 patients. Following completion of the RMTI-SFP-6 parent study, patients could enter the extension study, where they received SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate for up to 52 weeks.
- Conditions
- End Stage Renal Disease, Chronic Kidney Disease
- Being tested
- SFP, Placebo
- Keywords
- Soluble ferric pyrophosphate, Chronic kidney disease, Chronic hemodialysis, Ferric pyrophosphate citrate
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFPDrug
Also called Soluble ferric pyrophosphate
Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
PlaceboOther
Also called Standard liquid bicarbonate concentrate
Dialysis with standard liquid bicarbonate concentrate without iron
| Study group | Role | What they receive |
|---|---|---|
| SFP/Placebo | Other | Soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks Receives: Drug: SFP; Other: Placebo |
| Placebo/SFP | Other | Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks. Receives: Drug: SFP; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent Adverse Events
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention.
Measured: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met the protocol criteria for intradialytic hypotension. Intradialytic hypotension events were only to have been reported as adverse events if they exceeded the individual subject's baseline pattern of intradialytic hypotension.
Measured: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Incidence of Related Suspected Hypersensitivity Reactions
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met protocol criteria for suspected hypersensitivity reactions.
Measured: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Secondary outcomes (5)
Incidence of Composite Cardiovascular Events
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for composite cardiovascular events were pre-specified in the statistical analysis plan for the study.
Measured: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Incidence of Hemodialysis Vascular Access Thrombotic Events
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for hemodialysis vascular access thrombotic events were pre-specified in the statistical analysis plan for the study.
Measured: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Incidence of Other Thrombotic Events
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for other thrombotic events were pre-specified in the statistical analysis plan for the study.
Measured: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Incidence of Systemic/Serious Infections
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse events of systemic/serious infections were defined in the statistical analysis plan for the study to include infections for which the subject was administered at least 3 doses of an IV antibiotic, and infections for which the subject was hospitalized.
Measured: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Incidence of Serious Adverse Events
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met seriousness criteria.
Measured: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionJan 2014
- Study completionJan 2014
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 DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockwell Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ray Pratt, MD, Study director, Rockwell Medical, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503021
- Sponsor's protocol ID
- RMTI-SFP-6
- Status last verified
- Sep 2016
- First submitted
- 29 Dec 2011
- Last updated
- 25 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled, Crossover, Multicenter Phase III Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in Chronic Kidney Disease Patients Receiving Chronic Hemodialysis
- ClinicalTrials.gov ID
- NCT01503021
- Acronym / sponsor ID
- RMTI-SFP-6
- Conditions
- End Stage Renal Disease, Chronic Kidney Disease
- Keywords
- Soluble ferric pyrophosphate, Chronic kidney disease, Chronic hemodialysis, Ferric pyrophosphate citrate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- Rockwell Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 2 Jan 2012 (estimated)
- Results
- Posted 21 Apr 2015
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 the parent study is to assess the short-term safety and tolerability of soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of representative adult chronic kidney disease patients on hemodialysis (CKD-HD).
The purpose of the extension study is to assess the long-term safety and tolerability of SFP.
Detailed description
Parent Study: randomized, double-blinded, crossover, up to 6 weeks, 700 patients. Patients were randomized to receive SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate or placebo (standard liquid bicarbonate concentrate) x 2 weeks, then a 1 week washout, then crossed over to the alternate treatment x 2 weeks.
Extension Study: open-label, single active arm, uncontrolled study, up to 53 weeks, 300 patients. Following completion of the RMTI-SFP-6 parent study, patients could enter the extension study, where they received SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate for up to 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SFP/Placebo | Other | Drug: SFP, Other: PlaceboSoluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks |
| Placebo/SFP | Other | Drug: SFP, Other: PlaceboStandard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult ≥ 18 years of age.
- Has chronic kidney disease (CKD) receiving maintenance hemodialysis (HD) (CKD-HD subjects) and regularly undergoing 2 or more dialysis sessions per week.
- Stable pre-dialysis Hgb ≥ 9.0 to ≤ 12.5 g/dL.
- Stable pre-dialysis TSAT ≥ 15% to ≤ 45%.
- Stable pre-dialysis ferritin ≥ 100 to ≤ 1200 µg/L (1200 ng/mL).
Key exclusion criteria (12 listed)
- Any previous exposure to SFP.
- Therapy with intravenous, intramuscular or oral iron at any time between the first/screening visit and the randomization visit, or anticipated requirement for iron supplementation during the study period.
- Non-tunneled vascular catheter for dialysis.
- Scheduled for kidney transplant within the next 8 weeks.
- Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to screening, or during screening period prior to randomization.
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 |
|---|---|---|
| SFPAlso: Soluble ferric pyrophosphateDialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate | Drug | Placebo/SFP, SFP/Placebo |
| PlaceboAlso: Standard liquid bicarbonate concentrateDialysis with standard liquid bicarbonate concentrate without iron | Other | Placebo/SFP, SFP/Placebo |
Primary outcome
Incidence of Treatment-emergent Adverse Events
Time frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention.
Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension
Time frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met the protocol criteria for intradialytic hypotension. Intradialytic hypotension events were only to have been reported as adverse events if they exceeded the individual subject's baseline pattern of intradialytic hypotension.
Incidence of Related Suspected Hypersensitivity Reactions
Time frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met protocol criteria for suspected hypersensitivity reactions.
5 secondary outcomes
Incidence of Composite Cardiovascular Events
Time frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Incidence of Hemodialysis Vascular Access Thrombotic Events
Time frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Incidence of Other Thrombotic Events
Time frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Incidence of Systemic/Serious Infections
Time frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Incidence of Serious Adverse Events
Time frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- 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.
Ray Pratt, MD study director
Rockwell Medical, Inc
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SFP in people with End Stage Renal Disease and Chronic Kidney Disease, run by Rockwell Medical Technologies, Inc. at 31 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 9 inclusion and 12 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 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 21 Apr 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?
Incidence of Treatment-emergent Adverse Events (time frame: Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study). The study lists 3 primary outcomes in all. 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 25 Oct 2016.