Clinical trial NCT00548249: Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis
Official title: A Dose Ranging Study of Dialysate Containing Soluble Ferric Pyrophosphate (SFP) Versus Control in Subjects With ESRD Receiving Chronic Hemodialysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End-Stage Renal Disease (ESRD)
Keywords: Subjects with ESRD receiving chronic Hemodialysis
Lead sponsor: Rockwell Medical Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-23
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: up to 26 weeks
Secondary outcomes:
measure: Change From Baseline in Hemoglobin (Hgb)
timeFrame: two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks)
measure: 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.
timeFrame: Up to 26 weeks
measure: Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
timeFrame: Every 4 weeks
measure: Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group.
timeFrame: At each dialysis session for up to 26 weeks
measure: Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart.
timeFrame: two separate sessions measured one week apart.
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Investigator
state: Arizona
city: Hacienda Heights
country: United States
facility: Investigator
state: California
city: Los Angeles
country: United States
facility: Investigator
state: California
city: Whittier
country: United States
facility: Investigator
state: California
city: Augusta
country: United States
facility: Investigative Site
state: Georgia
city: Meridian
country: United States
facility: Investigator
state: Idaho
city: Chicago
country: United States
facility: Investigator
state: Illinois
city: Louisville
country: United States
facility: Investigative Site
state: Kentucky
city: New Orleans
country: United States
facility: Investigator
state: Louisiana
city: Springfield
country: United States
facility: Investigator
state: Massachusetts
city: Detroit
country: United States
facility: Investigative Site
state: Michigan
city: Hackensack
country: United States
facility: Investigator
state: New Jersey
city: Brooklyn
country: United States
facility: Investigator
state: New York
city: Great Neck
country: United States
facility: Investigator
state: New York
city: Mineola
country: United States
facility: Investigator
state: New York
city: New York
country: United States
facility: Investigator
state: New York
city: Ridgewood
country: United States
facility: Investigator
state: New York
city: Winston-Salem
country: United States
facility: Investigator
state: North Carolina
city: Canton
country: United States
facility: Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Investigator
state: Ohio
city: Hershey
country: United States
facility: Investigative Site
state: Pennsylvania
city: Arlington
country: United States
facility: Investigator
state: Texas
city: Fort Worth
country: United States
facility: Investigator
state: Texas
city: McAllen
country: United States
facility: Investigator
state: Texas
city: San Antonio
country: United States
facility: Investigator
state: Texas
city: Arlington
country: United States
facility: Investigator
state: Virginia
city: Seattle
country: United States
facility: Investigator
state: Washington
city: Edmonton
country: Canada
facility: Investigative Site
state: Alberta
Study officials:
affiliation: Rockwell Medical Technologies
name: Richard Yocum, MD
role: STUDY_DIRECTOR
References: