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

This study has been completed.
Sponsor:
Information provided by:
Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00548249
First received: October 19, 2007
Last updated: February 7, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Device: Standard Bicarbonate Solution
Drug: Soluble Ferric Pyrophosphate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Dose Ranging Study of Dialysate Containing Soluble Ferric Pyrophosphate (SFP) Versus Control in Subjects With ESRD Receiving Chronic Hemodialysis.

Resource links provided by NLM:


Further study details as provided by Rockwell Medical Technologies, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
    Efficacy of a Soluble Ferric Pyrophosphate (SFP)-containing dialysate solution in maintaining physiological iron levels during chronic HD, as measured by the percent of subjects whose hgb decreases by a total of 1.0 g/dL (or more) from baseline on each of two successive measurements. Hemoglobin was obtained weekly at the mid-week dialysis treatments and compared to baseline value (average of two hgb measurements obtained at the two consecutive baseline visits prior to randomization).


Secondary Outcome Measures:
  • Change From Baseline in Hemoglobin (Hgb) [ Time Frame: two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks) ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
    Kaplan-Meier Estimate of Time to First Hgb Decrease by >= 1.0 g/dL

  • Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
    Efficacy of SFP administration in dialysate solution as measured by Chr values every four weeks, and at the end of the Subject's Treatment (up to 26 weeks).

  • Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group. [ Time Frame: At each dialysis session for up to 26 weeks ] [ Designated as safety issue: No ]
  • Estimate the Amount of SFP Transferred From the Dialysate to the Blood During a Dialysis Session. [ Time Frame: At each dialysis session for up to 26 weeks ] [ Designated as safety issue: No ]
  • Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart. [ Time Frame: two separate sessions measured one week apart. ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: August 2007
Study Completion Date: January 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 0 µg iron/dL of dialysate
Placebo 0 micrograms (µg) of iron/ deciliter (dL) of dialysate
Device: Standard Bicarbonate Solution
Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Name: Placebo
Experimental: 5 µg iron/dL of dialysate
5 micrograms (µg) of iron/ deciliter (dL) of dialysate
Drug: Soluble Ferric Pyrophosphate
Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Name: SFP
Experimental: 10 µg iron/dL of dialysate
10 micrograms (µg) of iron/ deciliter (dL) of dialysate
Drug: Soluble Ferric Pyrophosphate
Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Name: SFP
Experimental: 12 µg iron/dL of dialysate
12 micrograms (µg) of iron/ deciliter (dL) of dialysate
Drug: Soluble Ferric Pyrophosphate
Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Name: SFP
Experimental: 15 µg iron/dL of dialysate
15 micrograms (µg) of iron/ deciliter (dL) of dialysate
Drug: 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 Name: SFP

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548249

  Show 28 Study Locations
Sponsors and Collaborators
Rockwell Medical Technologies, Inc.
Investigators
Study Director: Richard Yocum, MD Rockwell Medical Technologies
  More Information

No publications provided

Responsible Party: Robert Chioini, President and CEO, Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00548249     History of Changes
Other Study ID Numbers: RMTI-SFP-2
Study First Received: October 19, 2007
Results First Received: November 10, 2010
Last Updated: February 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Rockwell Medical Technologies, Inc.:
Subjects with ESRD receiving chronic Hemodialysis

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Iron
Dialysis Solutions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Pharmaceutical Solutions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014