Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients

NCT ID: NCT01286012

Last Updated: 2018-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-01-31

Brief Summary

The purpose of this study is to compare the clinical safety and efficacy of SFP in sparing the need for erythropoiesis stimulating agents (ESAs) required to maintain hemoglobin (hgb) levels in chronic hemodialysis subjects who receive SFP via the dialysate versus subjects who receive conventional dialysate without iron.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SFP in liquid bicarbonate

Group Type: ACTIVE_COMPARATOR

Soluble Ferric Pyrophosphate in liquid bicarbonate

Intervention Type: DRUG

Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.

Erythrocyte Stimulating Agent (ESA)

Intervention Type: DRUG

ESA was administered according to the recommendation of a blinded central anemia management center (CAMC) based on the weekly hemoglobin value and its rate of change.

Intravenous (IV) Iron

Intervention Type: DRUG

Approved IV iron preparations were administered per a protocol driven algorithm when patients serum ferritin value decreased below 200 ug/L.

Placebo: Conventional Liquid Bicarbonate

Control concentrate lacking SFP does not contain SFP (total iron = 0)

Group Type: PLACEBO_COMPARATOR

Placebo: Conventional liquid bicarbonate

Intervention Type: DRUG

Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking SFP at every dialysis session, for a total duration of 36 weeks.

Erythrocyte Stimulating Agent (ESA)

Intervention Type: DRUG

ESA was administered according to the recommendation of a blinded central anemia management center (CAMC) based on the weekly hemoglobin value and its rate of change.

Intravenous (IV) Iron

Intervention Type: DRUG

Approved IV iron preparations were administered per a protocol driven algorithm when patients serum ferritin value decreased below 200 ug/L.

Interventions

Soluble Ferric Pyrophosphate in liquid bicarbonate

Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.

Intervention Type: DRUG

Placebo: Conventional liquid bicarbonate

Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking SFP at every dialysis session, for a total duration of 36 weeks.

Intervention Type: DRUG

Erythrocyte Stimulating Agent (ESA)

ESA was administered according to the recommendation of a blinded central anemia management center (CAMC) based on the weekly hemoglobin value and its rate of change.

Intervention Type: DRUG

Intravenous (IV) Iron

Approved IV iron preparations were administered per a protocol driven algorithm when patients serum ferritin value decreased below 200 ug/L.

Intervention Type: DRUG

Other Intervention Names

SFP

Eligibility Criteria

Inclusion Criteria

1. Male and female subjects ≥ 18 years of age.

2. End-stage renal disease undergoing maintenance hemodialysis 3 to 4 times a week for at least 4 months and expected to remain on this schedule and be able to complete the study. Subjects on a cadaveric transplant list need not be excluded for this reason unless there is an identified donor.

3. Mean Hgb in the range of ≥ 9.5 to ≤ 12.0 g/dL during screening.

4. The difference between the maximum and minimum Hgb values during screening does not exceed 1.0 g/dL.

5. Mean ferritin ≥ 200 to ≤ 1000 µg/L during screening.

6. Mean TSAT ≥ 15% to ≤ 40% during screening.

7. Any and all serum albumin measured during the 2 months preceding randomization must be ≥ 3.0 g/dL.

8. Prescribed ESA dosing remaining in the range of ≥ 4,000 to ≤ 45,000 U/week epoetin or ≥ 12.5 to ≤ 200 µg/week darbepoetin during the 6 weeks preceding randomization.

9. Required IV iron at any time in the 6 months preceding randomization.

Exclusion Criteria

1. Vascular access for dialysis is a catheter.

2. During the 6 months prior to randomization, infection of the vascular access to be used at the time of randomization.

3. Received a total of > 600 mg IV iron during the 6 weeks prior to randomization.

4. Received any amount of IV or oral iron during the 2 weeks prior to randomization.

5. Change in prescribed ESA dose:

1. Any change in prescribed ESA dose within 4 weeks prior to randomization.

2. The prescribed ESA dose at the time of randomization is > 25% higher or lower than the prescribed dose at 6 weeks prior to randomization.

3. Change in prescribed type of ESA (e.g., epoetin vs. darbepoetin) or route of administration within 6 weeks prior to randomization.

6. Actual ESA dosing missed or withheld for a cumulative total of ≥ 1 week for any reason during the 6 weeks prior to randomization.

7. Known cause of anemia other than anemia attributable to renal disease (e.g., sickle cell disease, thalassemia, pure red cell aplasia, hemolytic anemia, myelodysplastic syndrome, etc.)

8. Scheduled kidney transplant or a donor has been identified but the transplant has not been scheduled.

9. Known ongoing inflammatory disorder (other than Chronic Kidney Disease), such as systemic lupus erythematosus, rheumatoid arthritis, other collagen-vascular diseases, etc.

11. Known active tuberculosis, fungal, viral, or parasitic infection requiring anti-microbial therapy or anticipated to require anti-microbial therapy during the patient's participation in this study. Subjects with hepatitis C, in the absence of cirrhosis, are not excluded from participation in the study if Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels are below 2 times the upper limit of normal on a consistent basis during the 2 months preceding randomization.

12. Occult tuberculosis requiring prophylactic treatment with anti-tubercular drug(s) that overlaps with the patient's participation in this study.

13. Cirrhosis of the liver based on histological criteria or clinical criteria (e.g., presence of ascites, esophageal varices, spider nevi, or history of hepatic encephalopathy).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rockwell Medical Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ray Pratt, MD

Role: STUDY_DIRECTOR

Rockwell Medical

Locations

Investigator

Birmingham, Alabama, United States

Investigator

Tempe, Arizona, United States

Investigator

Granada Hills, California, United States

Investigator

Colorado Springs, Colorado, United States

Investigator

Miami, Florida, United States

Investigator

Miami, Florida, United States

Investigator

Albany, Georgia, United States

Investigator

Hayden, Idaho, United States

Investigator

Louisville, Kentucky, United States

Investigator

New Orleans, Louisiana, United States

Investigator

Columbus, Mississippi, United States

Investigator

Kansas City, Missouri, United States

Investigator

Las Vegas, Nevada, United States

Investigator

Paterson, New Jersey, United States

Investigator

Lexington, North Carolina, United States

Investigator

Columbia, Tennessee, United States

Investigator

Duncanville, Texas, United States

Investigator

Greenville, Texas, United States

Investigator

San Antonio, Texas, United States

Investigator

San Antonio, Texas, United States

Investigator

St. George, Utah, United States

Investigator

Taylorsville, Utah, United States

Investigator

Fajardo, , Puerto Rico

Countries

United States; Puerto Rico

References

Gupta A, Lin V, Guss C, Pratt R, Ikizler TA, Besarab A. Ferric pyrophosphate citrate administered via dialysate reduces erythropoiesis-stimulating agent use and maintains hemoglobin in hemodialysis patients. Kidney Int. 2015 Nov;88(5):1187-94. doi: 10.1038/ki.2015.203. Epub 2015 Jul 8.

Reference Type: DERIVED

PMID: 26154926 (View on PubMed)

Other Identifiers

NIH-FP-01 PRIME

Identifier Type: -

Identifier Source: org_study_id