Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients

January 28, 2015 updated by: Rockwell Medical Technologies, Inc.

A Controlled, Randomized Study to Assess the Quantitative Mass Transfer of Iron From SFP-containing Hemodialysate Under Varying Conditions of Blood and Dialysate Flow Rates, Dialyzer Membrane Types and Dialysate Bicarbonate Concentrations in CKD-HD Patients.

The purpose of this study is to determine the quantity of iron derived from SFP that is transferred from the dialysate to patients during a single dialysis session. The effects of various conditions which may affect the transfer of iron such as blood and dialysate flow rate, changes in bicarbonate delivery, dialyzer membrane type and the effect of reuse will also be investigated. The absorption and removal of iron from the blood will also be investigated.

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

  • A total of 12 subjects on standard 3X/week hemodialysis will be studied in 2 groups (6 subjects per group)

  • 2 primary dialyzer membranes will be studied.:

    • Polyamide Membrane (Gambro Polyflux series: 17R and 21R)
    • Cellulose Triacetate (Baxter CT series: CT-190)
  • Each 1-week treatment cycle will include 3 haemodialysis (HD) sessions per subject, including 2 study treatment-HD sessions and 1 non-treatment-HD session per subject. Treatment-HD sessions will be conducted midweek and end-of-week (i.e. Dialysis days 3 and 5 of each week with a 1 day interdialytic interval) to avoid excessive fluid shifts due to the increased UF needed during the non-treatment HD session (conducted at beginning of the week; HD day 1).
  • Within each group, each subject will be randomized to 1 of 6 treatment sequences. The treatments to be investigated are: Control; new dialyzer, reused dialyzer, low blood flow/dialysate flow, Low bicarbonate concentration and a different synthetic dialyzer membrane (PAES)
  • Blood for a complete serum iron profile over time will be obtained during the new dialyzer (SFP/standard bicarbonate/new dialyzer/ high Qb and Qd) for all subjects. This will necessitate approximately a 24-hour inpatient confinement to obtain blood at specified time intervals after dialysis is completed. Blood for a partial iron profile will be collected during the dialysis sessions at all other dialysis sessions.
  • Each of the 6 enrolled subjects per dialyzer membrane type will be assigned to a different sequence of treatments to help ensure that the treatment sequence does not affect the analysis (Note: the first dialysis sessions of each of the 3 study weeks, i.e. HD1, HD4 and HD7, are non-study related sessions during which no study procedures are performed except for adverse event collection.

  • Patients should not be receiving any of the following medications from screening through the end of the study:

    • Oral iron preparations, including multivitamin supplements containing iron
    • Intravenous iron preparations
  • Doses of ESA's should not be changed from screening to the end of the study.

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.
12

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
  • Phase 1

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

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404

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

Inclusion Criteria:

  1. Adult subject ≥ 18 years of age undergoing chronic hemodialysis for chronic kidney disease (CKD) for at least 3 months, expected to remain on hemodialysis and be able to complete the study.
  2. Screening Hgb ≥ 9.5 g/dL.
  3. Screening transferrin saturation % (TSAT) ≥ 15% to ≤ 45%.
  4. Screening serum ferritin ≥ 200 to ≤ 1200 µg/L.
  5. Subject's standard dialyzer membrane is one of the 2 types, i.e. Baxter CT-190 or Gambro 17R or 21R.
  6. The subject uses a reprocessed dialyzer for standard HD treatments.
  7. Prescribed dialysis 3X/week.
  8. Minimally adequate measured dialysis dose defined as URR (urea reduction ratio) ≥ 65%, or single-pool Kt/V (dialyzer clearance of urea multiplied by dialysis time, divided by patient's total body water) ≥ 1.2, or KIDt/V (online dialyzer clearance measured using ionic dialysance multiplied by dialysis time, divided by patients total body water) ≥ 1.2.
  9. Stable dialyzer blood flow rate that is generally ≥ 350 mL/min and acceptable to the Investigator.
  10. Stable dialysate flow rate that is generally ≥ 600 mL/min and acceptable to the Investigator.
  11. Vascular access for dialysis that will be used upon enrollment with stable function in the judgment of the Investigator.
  12. Female subjects must be either amenorrheic for ≥ 1 year or agree to not become pregnant by continuous use of an effective birth control method acceptable to the Investigator for the duration of their participation in the study.
  13. Must be willing and able to provide written informed consent directly or through their authorized representative.

Exclusion Criteria:

  1. Subject has a living kidney donor identified or living-donor kidney transplant scheduled during study participation. (Note: Patients awaiting deceased-donor transplant need not be excluded.)
  2. Vascular access for hemodialysis is a femoral catheter.
  3. Known active bleeding from any site other than AV fistula or graft (e.g., gastrointestinal, hemorrhoidal, nasal, pulmonary, etc.).
  4. Scheduled surgery during the study.
  5. RBC or whole blood transfusion within 4 weeks prior to Screening.
  6. Hospitalization in the month prior to Screening (except for vascular access surgery) that, in the opinion of the Investigator, confers a significant risk of hospitalization during the course of this study.
  7. Evidence of current malignancy involving a site other than skin (except any melanoma, which renders the patient non-eligible).
  8. History of drug or alcohol abuse within the last 6 months.
  9. Regularly requiring hemodialysis more than three times per week.
  10. Noncompliance with dialysis regimen in the opinion of the Investigator.
  11. Pregnancy or intention to become pregnant before completing all study drug treatment.
  12. Known ongoing inflammatory disorder (other than CKD), such as systemic lupus erythematosus, rheumatoid arthritis, or other collagen-vascular disease undergoing a disease flare.
  13. Any current febrile illness (e.g., oral temperature > 100.4°F, 38°C). (The patient may subsequently become eligible at least 1 week after resolution of the illness).
  14. Known active bacterial, tuberculosis, fungal, viral, or parasitic infection requiring anti-microbial therapy or anticipated to require anti-microbial therapy during the patient's participation in this study.
  15. Occult tuberculosis requiring prophylactic treatment with anti-tubercular drug(s) that overlaps with the patient's participation in this study.
  16. Known positive status for hepatitis B surface antigen (hepatitis B testing is not required as part of this protocol).
  17. Known human immunodeficiency virus (HIV) infection (HIV testing is not required as part of this protocol).
  18. Cirrhosis of the liver based on histological criteria or clinical criteria (i.e., presence of ascites, esophageal varices, multiple spider nevi, or history of hepatic encephalopathy).
  19. Active hepatitis with ALT and/or AST levels consistently greater than twice the upper limit of normal at any time during the two months prior to enrollment.
  20. Participation in a study of an investigational drug or device within 30 days prior to randomization in this study.

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: Crossover Assignment
  • Masking: None (Open Label)

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: Control
Each subject will receive one control treatment and 5 treatments with SFP added to dialysate. The 5 SFP treatments will encompass 5 different conditions which may impact the intradialytic transfer of iron to the subject: new dialyzer, reused dialyzer, low blood/dialysate flow rate, low machine delivered bicarbonate concentration, and a different synthetic dialysis membrane (PAES).
Other: Placebo
Experimental: Soluble Ferric Pyrophosphate
Group/ cohort designation: Cellulose dialysis membrane (CT-190)/ Polyamide membrane. Each subject will receive one control treatment and 5 treatments with SFP added to dialysate. The 5 SFP treatments will encompass 5 different conditions which may impact the intradialytic transfer of iron to the subject: new dialyzer, reused dialyzer, low blood/dialysate flow rate, low machine delivered bicarbonate concentration, and a different synthetic dialysis membrane (PAES).
Drug: Soluble Ferric Pyrophosphate
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
Net Iron Delivery From SFP Via the Dialysate
Time Frame: one dialysis session (approximately 4 hours)
To measure the SFP-derived total iron from the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate). Expended dialysate over the intervals of 0.5, 1, 2 ,3 and 4 hours will be collected and measured. Aliquots will be analyzed for iron content. The mean cumulative net iron delivery will be reported.
one dialysis session (approximately 4 hours)

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
To Compare the Amount of SFP-derived Iron Administered Under Various Treatment Conditions to the Reference HD
Time Frame: one dialysis session (approximately 4 hours)
To compare the amount of SFP-derived iron administered under various treatment conditions to the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate): Dialyzer reuse, Low machine bicarbonate delivery, Polyarylethersulfone (PAES) membrane, and Low Qb/Qd.Iron concentration in timed dialysate collections will be analyzed. Expended dialysate over the intervals of 0.5, 1, 2 ,3 and 4 hours will be collected and measured. Aliquots will be analyzed for iron content. The mean cumulative net iron delivery will be reported.
one dialysis session (approximately 4 hours)
Pharmacokinetics of Serum Iron and Exploratory Modeling
Time Frame: one dialysis session (approximately 4 hours)
The serum Total Iron, Transferrin Bound Iron (TBI) and Non-transferrin Bound Iron (NTBI) pharmacokinetic parameters (baseline corrected and total) will be listed and summarized for each membrane group and overall. The mean serum total iron, TBI, NTBI, unsaturation iron binding capacity (UIBC) and total iron binding capacity (TIBC) concentrations at baseline (BL), end-of-treatment, and the change from BL will be listed for each group (Baxter and Gambro Polyflux), measured from the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate).
one dialysis session (approximately 4 hours)
Dialysate InFlow Iron Concentration
Time Frame: 4 hours
Dialysate inflow iron concentration was calculated for each treatment group at t = 0, 0.5, 1, 2, 3, and 4 hours.
4 hours
Dialysate OutFlow Iron Concentration
Time Frame: 4 hours
Dialysate outflow iron concentration was calculated for each treatment group at t = 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours.
4 hours

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: Raymond D Pratt, MC FACP, Rockwell Medical Inc

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.
July 1, 2013

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.
September 1, 2013

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.
September 1, 2013

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).
June 27, 2013

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.
July 3, 2013

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.
July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

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.
February 16, 2015

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.
January 28, 2015

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.
January 1, 2015

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-8

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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