Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)
Condition: Renal Failure Chronic Requiring Hemodialysis
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Intervention: Soluble Ferric Pyrophosphate (SFP); Standard dialysate
Intervention description: Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months.; Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week.
Intervention MeSH terms: Dialysis Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 294.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: End Stage Renal Disease; Hemodialysis; SFP; Hemodialysis-dependent chronic renal failure

Summary:

      The purpose of this study is to confirm the safety and efficacy of Soluble Ferric
      Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in
      anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will
      be measured primarily by the change from baseline in hemoglobin (Hgb).
    

Eligibility criteria:

        Stage 1:

        Main Inclusion Criteria:

          -  Adult subject ≥ 18 years of age undergoing chronic hemodialysis three or four times
             per week for chronic kidney disease (CKD) for at least 4 months, and expected to
             remain on hemodialysis three to four times weekly and be able to complete the duration
             of the study.

          -  Received IV iron therapy between 6 months and 2 weeks prior to enrollment in order to
             replace iron losses resulting from hemodialysis procedure.

          -  Mean Screening Hgb ≥ 9.5 to ≤ 11.5 grams per deciliter (g/dL).

          -  Mean Screening Transferrin Saturation (TSAT) ≥ 15% to ≤ 40%.

          -  Mean Screening serum ferritin ≥ 200 to ≤ 800 micrograms per liter (µg/L).

          -  If being administered epoetin, darbepoetin, or CERA, epoetin dose ≤ 45,000 Units
             (U)/week, darbepoetin dose ≤ 200 micrograms (µg)/week, or CERA dose ≤ 400 micrograms
             (µg)/month during the four weeks prior to enrollment.

        Main Exclusion Criteria:

          -  Patient has living kidney donor identified or living-donor kidney transplant
             scheduled. (Note: Patients awaiting deceased-donor transplant need not be excluded.)

          -  Vascular access for dialysis with femoral catheter or non-tunneled catheter.

          -  Received a total of > 800 milligrams (mg) IV iron during the 8 weeks prior to
             enrollment.

          -  If being administered an ESA, route of administration change or ESA dose change > 35%
             (i.e., [max - min dose]/max dose > 0.35) over the 2 weeks prior to screening.

          -  Serum albumin < 3.0 grams per deciliter (g/dL) any time over the 8 weeks prior to
             enrollment.

          -  Red Blood Cell (RBC) or whole blood transfusion within 12 weeks prior to enrollment.

        Stage 2:

        Main Inclusion Criteria:

          -  Patient currently enrolled in the Stage 1 run-in period of study.

          -  Undergoing chronic hemodialysis three or four times per week for chronic kidney
             disease (CKD), and expected to remain on hemodialysis three to four times weekly and
             be able to complete duration of the study.

          -  Mean Hgb ≥ 9.5 to ≤ 11.5 g/dL over the three most recent consecutive every-week
             measurements prior to randomization.

          -  Stable Hgb defined as ≤ 1.0 g/dL difference between the maximum and minimum Hgb values
             over the 3 weeks immediately prior to randomization.

          -  Mean TSAT ≥ 15% to ≤ 40% over the two most recent consecutive every-other-week
             measurements prior to randomization.

          -  Mean serum ferritin ≥ 200 to ≤ 800 µg/L over the two most recent consecutive
             every-other-week measurements prior to randomization.

          -  If being administered epoetin, darbepoetin, or CERA, epoetin dose ≤ 45,000 U/week,
             darbepoetin dose ≤ 200 µg/week, or CERA dose ≤ 400 µg/month during the four weeks
             prior to randomization.

        Main Exclusion Criteria:

          -  Patient has living kidney donor identified or living-donor kidney transplant
             scheduled. (Note: Patients awaiting deceased-donor transplant need not be excluded.)

          -  Vascular access for dialysis with femoral catheter or non-tunneled catheter.

          -  Received any amount of IV iron during the 4 weeks prior to randomization.

          -  If being administered an (Erythropoietin Stimulating Agent) ESA, change in dose over
             the 6 weeks immediately prior to randomization.

          -  Serum albumin < 3.0 g/dL any time over the 8 weeks prior to randomization.

          -  RBC or whole blood transfusion during Stage 1.

        Stage 3:

        Main Inclusion Criteria:

          -  Patient randomized in Stage 2 who has completed the full duration of Stage 2 and less
             than 4 weeks have elapsed since completion of Stage 2, OR

          -  Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for
             protocol-defined Protocol-Mandated Change in Anemia Management and less than 4 weeks
             have elapsed since withdrawal from Stage 2, OR

          -  Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for Hgb >11.5 g/dL
             over ≥ 1 week confirmed by ≥ 2 consecutive measurements AND an associated increase in
             Hgb by ≥ 1 g/dL over 4 weeks.

        Main Exclusion Criteria:

          -  Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for any reason
             other than as noted in inclusion criteria above.