Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis
NCT ID: NCT00548249
Last Updated: 2020-12-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
131 participants
INTERVENTIONAL
2007-08-31
2010-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
0 µg iron/dL of dialysate
Placebo 0 micrograms (µg) of iron/ deciliter (dL) of dialysate
Standard Bicarbonate Solution
Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
5 µg iron/dL of dialysate
5 micrograms (µg) of iron/ deciliter (dL) of dialysate
Soluble Ferric Pyrophosphate
Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
10 µg iron/dL of dialysate
10 micrograms (µg) of iron/ deciliter (dL) of dialysate
Soluble Ferric Pyrophosphate
Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
12 µg iron/dL of dialysate
12 micrograms (µg) of iron/ deciliter (dL) of dialysate
Soluble Ferric Pyrophosphate
Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
15 µg iron/dL of dialysate
15 micrograms (µg) of iron/ deciliter (dL) of dialysate
Soluble Ferric Pyrophosphate
Patients received 15 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard Bicarbonate Solution
Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Soluble Ferric Pyrophosphate
Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Soluble Ferric Pyrophosphate
Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Soluble Ferric Pyrophosphate
Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rockwell Medical Technologies, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Richard Yocum, MD
Role: STUDY_DIRECTOR
Rockwell Medical Technologies
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigator
Tempe, Arizona, United States
Investigator
Hacienda Heights, California, United States
Investigator
Los Angeles, California, United States
Investigator
Whittier, California, United States
Investigative Site
Augusta, Georgia, United States
Investigator
Meridian, Idaho, United States
Investigator
Chicago, Illinois, United States
Investigative Site
Louisville, Kentucky, United States
Investigator
New Orleans, Louisiana, United States
Investigator
Springfield, Massachusetts, United States
Investigative Site
Detroit, Michigan, United States
Investigator
Hackensack, New Jersey, United States
Investigator
Brooklyn, New York, United States
Investigator
Great Neck, New York, United States
Investigator
Mineola, New York, United States
Investigator
New York, New York, United States
Investigator
Ridgewood, New York, United States
Investigator
Winston-Salem, North Carolina, United States
Investigative Site
Canton, Ohio, United States
Investigator
Cincinnati, Ohio, United States
Investigative Site
Hershey, Pennsylvania, United States
Investigator
Arlington, Texas, United States
Investigator
Fort Worth, Texas, United States
Investigator
McAllen, Texas, United States
Investigator
San Antonio, Texas, United States
Investigator
Arlington, Virginia, United States
Investigator
Seattle, Washington, United States
Investigative Site
Edmonton, Alberta, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RMTI-SFP-2
Identifier Type: -
Identifier Source: org_study_id