Status:
COMPLETED
Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients
Lead Sponsor:
Rockwell Medical Technologies, Inc.
Conditions:
Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 w...
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 s...
Eligibility Criteria
Inclusion
- 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.
- Screening Hgb ≥ 9.5 g/dL.
- Screening transferrin saturation % (TSAT) ≥ 15% to ≤ 45%.
- Screening serum ferritin ≥ 200 to ≤ 1200 µg/L.
- Subject's standard dialyzer membrane is one of the 2 types, i.e. Baxter CT-190 or Gambro 17R or 21R.
- The subject uses a reprocessed dialyzer for standard HD treatments.
- Prescribed dialysis 3X/week.
- 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.
- Stable dialyzer blood flow rate that is generally ≥ 350 mL/min and acceptable to the Investigator.
- Stable dialysate flow rate that is generally ≥ 600 mL/min and acceptable to the Investigator.
- Vascular access for dialysis that will be used upon enrollment with stable function in the judgment of the Investigator.
- 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.
- Must be willing and able to provide written informed consent directly or through their authorized representative.
Exclusion
- 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.)
- Vascular access for hemodialysis is a femoral catheter.
- Known active bleeding from any site other than AV fistula or graft (e.g., gastrointestinal, hemorrhoidal, nasal, pulmonary, etc.).
- Scheduled surgery during the study.
- RBC or whole blood transfusion within 4 weeks prior to Screening.
- 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.
- Evidence of current malignancy involving a site other than skin (except any melanoma, which renders the patient non-eligible).
- History of drug or alcohol abuse within the last 6 months.
- Regularly requiring hemodialysis more than three times per week.
- Noncompliance with dialysis regimen in the opinion of the Investigator.
- Pregnancy or intention to become pregnant before completing all study drug treatment.
- Known ongoing inflammatory disorder (other than CKD), such as systemic lupus erythematosus, rheumatoid arthritis, or other collagen-vascular disease undergoing a disease flare.
- 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).
- 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.
- Occult tuberculosis requiring prophylactic treatment with anti-tubercular drug(s) that overlaps with the patient's participation in this study.
- Known positive status for hepatitis B surface antigen (hepatitis B testing is not required as part of this protocol).
- Known human immunodeficiency virus (HIV) infection (HIV testing is not required as part of this protocol).
- 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).
- 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.
- Participation in a study of an investigational drug or device within 30 days prior to randomization in this study.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01894906
Start Date
July 1 2013
End Date
September 1 2013
Last Update
February 16 2015
Active Locations (1)
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1
Minneapolis, Minnesota, United States, 55404