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

NCT00548249 | Completed Phase 2 Results DMC

• 1 other identifier: RMTI-SFP-2
• Study Type: interventional
• Target: 131
• Locations: 2 countries
• Sites: 28

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.

Conditions

End-Stage Renal Disease (ESRD)

Keywords

Subjects with ESRD receiving chronic Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  up to 26 weeks

Secondary Outcomes (5)

• Change From Baseline in Hemoglobin (Hgb)

  two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks)

• 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.

  Up to 26 weeks

• Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.

  Every 4 weeks

• Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group.

  At each dialysis session for up to 26 weeks

• Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart.

  two separate sessions measured one week apart.

Study Arms (5)

0 µg iron/dL of dialysate

PLACEBO COMPARATOR

Placebo 0 micrograms (µg) of iron/ deciliter (dL) of dialysate

Device: Standard Bicarbonate Solution

5 µg iron/dL of dialysate

EXPERIMENTAL

5 micrograms (µg) of iron/ deciliter (dL) of dialysate

Drug: Soluble Ferric Pyrophosphate

10 µg iron/dL of dialysate

EXPERIMENTAL

10 micrograms (µg) of iron/ deciliter (dL) of dialysate

Drug: Soluble Ferric Pyrophosphate

12 µg iron/dL of dialysate

EXPERIMENTAL

12 micrograms (µg) of iron/ deciliter (dL) of dialysate

Drug: Soluble Ferric Pyrophosphate

15 µg iron/dL of dialysate

EXPERIMENTAL

15 micrograms (µg) of iron/ deciliter (dL) of dialysate

Drug: Soluble Ferric Pyrophosphate

Interventions

Standard Bicarbonate Solution DEVICE

Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.

Also known as: Placebo

0 µg iron/dL of dialysate

Soluble Ferric Pyrophosphate DRUG

Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.

Also known as: SFP

5 µg iron/dL of dialysate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subject ≥ 18 years of age undergoing chronic hemodialysis for end-stage renal disease (ESRD) three times a week
• 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
• Transferrin Saturation (TSAT) values that average 20% or more, but not exceeding 35%, prior to dialysis measured during the screening period
• 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%.
• 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.
• Subject has an adequate dialyzer blood flow rate that is acceptable to the Principal Investigator

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)

Sponsors & Collaborators

• Rockwell Medical Technologies, Inc.: lead

Study Sites (28)

Investigator

Tempe, Arizona, 85284, United States

Location

Investigator

Hacienda Heights, California, 91745, United States

Location

Investigator

Los Angeles, California, 90059, United States

Location

Investigator

Whittier, California, 90603, United States

Location

Investigative Site

Augusta, Georgia, 30901, United States

Location

Investigator

Meridian, Idaho, 83642, United States

Location

Investigator

Chicago, Illinois, 60617, United States

Location

Investigative Site

Louisville, Kentucky, 40202-1718, United States

Location

Investigator

New Orleans, Louisiana, 70115, United States

Location

Investigator

Springfield, Massachusetts, 01107, United States

Location

Investigative Site

Detroit, Michigan, 48202, United States

Location

Investigator

Hackensack, New Jersey, 07601, United States

Location

Investigator

Brooklyn, New York, 11212, United States

Location

Investigator

Great Neck, New York, 11021, United States

Location

Investigator

Mineola, New York, 11501, United States

Location

Investigator

New York, New York, 10013, United States

Location

Investigator

Ridgewood, New York, 11385, United States

Location

Investigator

Winston-Salem, North Carolina, 27103, United States

Location

Investigative Site

Canton, Ohio, 44718, United States

Location

Investigator

Cincinnati, Ohio, 45229, United States

Location

Investigative Site

Hershey, Pennsylvania, 17033, United States

Location

Investigator

Arlington, Texas, 76011, United States

Location

Investigator

Fort Worth, Texas, 76105, United States

Location

Investigator

McAllen, Texas, 78503, United States

Location

Investigator

San Antonio, Texas, 78207, United States

Location

Investigator

Arlington, Virginia, 22206, United States

Location

Investigator

Seattle, Washington, 92133, United States

Location

Investigative Site

Edmonton, Alberta, T6G2B7, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

spleen fibrinolytic proteinase (human)

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

AE tabulation best summarizes the primary safety outcome. Lack of accuracy in analytical method for measuring iron concentration in inflow and outflow from dialysis machine impaired ability to assess secondary outcome of amount SFP transferred.

Results Point of Contact

• Title: Richard C. Yocum, MD
• Organization: Rockwell Medical

ryocum@rockwellmed.com

858-229-8585

Study Officials

• Richard Yocum, MD

  Rockwell Medical Technologies

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 23, 2007
• Study Start: August 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: January 1, 2010
• Last Updated: December 2, 2020
• Results First Posted: February 8, 2011

Record last verified: 2020-11

Locations

US (27); CA (1)