Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis

November 17, 2020 updated by: Rockwell Medical Technologies, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
131

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2B7
        • Investigative Site
  • United States
    • Arizona
      • Tempe, Arizona, United States, 85284
        • Investigator
    • California
      • Hacienda Heights, California, United States, 91745
        • Investigator
      • Los Angeles, California, United States, 90059
        • Investigator
      • Whittier, California, United States, 90603
        • Investigator
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Investigative Site
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Investigator
    • Illinois
      • Chicago, Illinois, United States, 60617
        • Investigator
    • Kentucky
      • Louisville, Kentucky, United States, 40202-1718
        • Investigative Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Investigator
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Investigator
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Investigative Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Investigator
    • New York
      • Brooklyn, New York, United States, 11212
        • Investigator
      • Great Neck, New York, United States, 11021
        • Investigator
      • Mineola, New York, United States, 11501
        • Investigator
      • New York, New York, United States, 10013
        • Investigator
      • Ridgewood, New York, United States, 11385
        • Investigator
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Investigator
    • Ohio
      • Canton, Ohio, United States, 44718
        • Investigative Site
      • Cincinnati, Ohio, United States, 45229
        • Investigator
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Investigative Site
    • Texas
      • Arlington, Texas, United States, 76011
        • Investigator
      • Fort Worth, Texas, United States, 76105
        • Investigator
      • McAllen, Texas, United States, 78503
        • Investigator
      • San Antonio, Texas, United States, 78207
        • Investigator
    • Virginia
      • Arlington, Virginia, United States, 22206
        • Investigator
    • Washington
      • Seattle, Washington, United States, 92133
        • Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Selected Inclusion Criteria:

  1. Adult subject ≥ 18 years of age undergoing chronic hemodialysis for end-stage renal disease (ESRD) three times a week
  2. Hemoglobin (Hgb) values on two successive screening/baseline measures immediately prior to the start of the study averaging 10.1 to 11.5 grams/ deciliter (g/dL), inclusive
  3. Transferrin Saturation (TSAT) values that average 20% or more, but not exceeding 35%, prior to dialysis measured during the screening period
  4. Ferritin values that average 200 to 800 micrograms/ liter (µg/L), inclusive, measured during the screening period. An average ferritin above 800 µg/L but no greater than 1200 µg/L is allowed if the average TSAT is 20% to no greater than 25%.
  5. Except for vascular access surgery, subject has no hospitalization in previous three months for a significant illness that, in the opinion of the Investigator, confers a significant risk of hospitalization during the course of the study. No blood transfusions within the last 4 weeks are allowed.
  6. Subject has an adequate dialyzer blood flow rate that is acceptable to the Principal Investigator

Exclusion Criteria:

  1. Hemoglobin (Hgb) values on two successive baseline/screening measurements that average ≥ 11.6g/dL
  2. Subject with a current malignancy involving a site other than skin
  3. Subject with a history of drug or alcohol abuse within the last six months
  4. Subject believed to be unable to complete the entire study (e.g., due to a concurrent disease, life expectancy of less than a year)
  5. Subject who the Principal Investigator considers will be placed at increased risk by the study procedures
  6. Subject requiring hemodialysis more than 3 times per week on a regular basis.
  7. Subject who is unable to discontinue oral iron or intravenous iron supplements for the duration of the study
  8. Subject who is pregnant
  9. Subject considered incompetent to give an informed consent
  10. Subject with a positive test for Hepatitis B Surface Antigen within the past 30 days or during screening
  11. Subject with known HIV infection (if this is not known, no HIV testing will be performed)
  12. 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
  13. Subject with active tuberculosis, fungal, viral, or parasitic infection
  14. Subject with active bacterial infection requiring antibiotic therapy
  15. Subject with pre-dialysis Corrected Q-wave to T-wave (QTc) interval ≥ 470 milliseconds (ms)
  16. 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
  17. Subject using concomitant medications known to prolong QT/QTc interval (See Appendix I, TABLE A)
  18. Subject receiving more than 60,000 units or 120 micrograms of erythropoietin (Epogen®, Procrit®, or Aranesp®) per week
  19. Subject has participated in another clinical trial within 30 days of signing Informed Consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 0 µg iron/dL of dialysate
Placebo 0 micrograms (µg) of iron/ deciliter (dL) of dialysate
Device: Standard Bicarbonate Solution
Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • Placebo
Experimental: 5 µg iron/dL of dialysate
5 micrograms (µg) of iron/ deciliter (dL) of dialysate
Drug: Soluble Ferric Pyrophosphate
Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP
Drug: Soluble Ferric Pyrophosphate
Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP
Drug: Soluble Ferric Pyrophosphate
Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP
Drug: Soluble Ferric Pyrophosphate
Patients received 15 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP
Experimental: 10 µg iron/dL of dialysate
10 micrograms (µg) of iron/ deciliter (dL) of dialysate
Drug: Soluble Ferric Pyrophosphate
Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP
Drug: Soluble Ferric Pyrophosphate
Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP
Drug: Soluble Ferric Pyrophosphate
Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP
Drug: Soluble Ferric Pyrophosphate
Patients received 15 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP
Experimental: 12 µg iron/dL of dialysate
12 micrograms (µg) of iron/ deciliter (dL) of dialysate
Drug: Soluble Ferric Pyrophosphate
Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP
Drug: Soluble Ferric Pyrophosphate
Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP
Drug: Soluble Ferric Pyrophosphate
Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP
Drug: Soluble Ferric Pyrophosphate
Patients received 15 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP
Experimental: 15 µg iron/dL of dialysate
15 micrograms (µg) of iron/ deciliter (dL) of dialysate
Drug: Soluble Ferric Pyrophosphate
Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP
Drug: Soluble Ferric Pyrophosphate
Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP
Drug: Soluble Ferric Pyrophosphate
Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP
Drug: Soluble Ferric Pyrophosphate
Patients received 15 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
  • SFP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
up to 26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin (Hgb)
Time Frame: two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks)
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
Kaplan-Meier Estimate of Time to First Hgb Decrease by >= 1.0 g/dL
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
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).
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
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.
two separate sessions measured one week apart.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rockwell Medical Technologies, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Richard Yocum, MD, Rockwell Medical Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RMTI-SFP-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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