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

Completed · Phase 2 · Has a placebo group

Conditions studied: End-Stage Renal Disease (ESRD)

In brief

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.

Key facts

Study ID

NCT00548249

Run by

Rockwell Medical Technologies, Inc.

People needed

131

Starts

2007-08-01

Expected to finish

2010-01-01

Last updated by the study team

2020-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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