Trial Outcomes & Findings for Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients (NCT NCT01894906)

Last Updated: 2015-02-16

Results Overview

To measure the SFP-derived total iron from the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate). Expended dialysate over the intervals of 0.5, 1, 2 ,3 and 4 hours will be collected and measured. Aliquots will be analyzed for iron content. The mean cumulative net iron delivery will be reported.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

one dialysis session (approximately 4 hours)

Results posted on

2015-02-16

Participant Flow

19 patients were screened and 12 total patients were enrolled. Each patient participated in each of the 6 treatment periods.

Participant milestones

Participant milestones
Measure	Baxter CT-190 (Group 1: Cellulose Triacetate Membrane) Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.	Gambro 17R/21R (Group 2: Polyamide Membrane) Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
Overall Study STARTED	6	6
Overall Study Treatment A	6	6
Overall Study Treatment B	6	6
Overall Study Treatment C	6	6
Overall Study Treatment D	6	6
Overall Study Treatment E	6	6
Overall Study Treatment F	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baxter CT-190 (Group 1: Cellulose Triacetate Membrane) n=6 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.	Gambro 17R/21R (Group 2: Polyamide Membrane). n=6 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.	Total n=12 Participants Total of all reporting groups
Age, Continuous	51.8 years STANDARD_DEVIATION 14.73 • n=5 Participants	52.8 years STANDARD_DEVIATION 8.89 • n=7 Participants	52.3 years STANDARD_DEVIATION 11.61 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
BMI	26.425 kg/m^2 STANDARD_DEVIATION 6.1611 • n=5 Participants	28.332 kg/m^2 STANDARD_DEVIATION 6.6425 • n=7 Participants	27.378 kg/m^2 STANDARD_DEVIATION 6.1888 • n=5 Participants

PRIMARY outcome

Timeframe: one dialysis session (approximately 4 hours)

Population: For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.

Outcome measures

Outcome measures
Measure	Control n=12 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.	Treatment B Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.	Treatment C Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.	Treatment D Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.	Treatment E Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.	Treatment F Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
Net Iron Delivery From SFP Via the Dialysate	692 microgram Standard Deviation 1010	—	—	—	—	—

SECONDARY outcome

Timeframe: one dialysis session (approximately 4 hours)

To compare the amount of SFP-derived iron administered under various treatment conditions to the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate): Dialyzer reuse, Low machine bicarbonate delivery, Polyarylethersulfone (PAES) membrane, and Low Qb/Qd.Iron concentration in timed dialysate collections will be analyzed. Expended dialysate over the intervals of 0.5, 1, 2 ,3 and 4 hours will be collected and measured. Aliquots will be analyzed for iron content. The mean cumulative net iron delivery will be reported.

Outcome measures

Outcome measures
Measure	Control n=12 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.	Treatment B n=12 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.	Treatment C n=12 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.	Treatment D n=12 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.	Treatment E n=12 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.	Treatment F n=12 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
To Compare the Amount of SFP-derived Iron Administered Under Various Treatment Conditions to the Reference HD	-18.5 microgram Standard Deviation 175	692 microgram Standard Deviation 1010	578 microgram Standard Deviation 1380	587 microgram Standard Deviation 994	130 microgram Standard Deviation 594	350 microgram Standard Deviation 1940

SECONDARY outcome

Timeframe: one dialysis session (approximately 4 hours)

The serum Total Iron, Transferrin Bound Iron (TBI) and Non-transferrin Bound Iron (NTBI) pharmacokinetic parameters (baseline corrected and total) will be listed and summarized for each membrane group and overall. The mean serum total iron, TBI, NTBI, unsaturation iron binding capacity (UIBC) and total iron binding capacity (TIBC) concentrations at baseline (BL), end-of-treatment, and the change from BL will be listed for each group (Baxter and Gambro Polyflux), measured from the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate).

Outcome measures

Outcome measures
Measure	Control n=6 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.	Treatment B n=6 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.	Treatment C n=12 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.	Treatment D Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.	Treatment E Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.	Treatment F Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
Pharmacokinetics of Serum Iron and Exploratory Modeling Baseline TIBC	244.7 microgram/dL Standard Deviation 49.31	221.7 microgram/dL Standard Deviation 52.88	233.2 microgram/dL Standard Deviation 50.21	—	—	—
Pharmacokinetics of Serum Iron and Exploratory Modeling End-of Treatment TIBC	247.2 microgram/dL Standard Deviation 39.83	233.5 microgram/dL Standard Deviation 61.40	240.3 microgram/dL Standard Deviation 49.85	—	—	—
Pharmacokinetics of Serum Iron and Exploratory Modeling TIBC Change from BL to EoT	2.5 microgram/dL Standard Deviation 41.95	11.8 microgram/dL Standard Deviation 14.50	7.2 microgram/dL Standard Deviation 30.32	—	—	—

SECONDARY outcome

Timeframe: 4 hours

Dialysate inflow iron concentration was calculated for each treatment group at t = 0, 0.5, 1, 2, 3, and 4 hours.

Outcome measures

Outcome measures
Measure	Control n=12 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.	Treatment B n=12 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.	Treatment C n=12 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.	Treatment D n=12 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.	Treatment E n=12 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.	Treatment F n=12 Participants Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
Dialysate InFlow Iron Concentration t = 0 hours	12.5 micrograms/L Standard Deviation 43.3	0 micrograms/L Standard Deviation 0	0 micrograms/L Standard Deviation 0	1.9 micrograms/L Standard Deviation 6.58	0 micrograms/L Standard Deviation 0	0 micrograms/L Standard Deviation 0
Dialysate InFlow Iron Concentration t = 0.5 hours	0 micrograms/L Standard Deviation 0	71 micrograms/L Standard Deviation 6.87	74.1 micrograms/L Standard Deviation 9.44	63.3 micrograms/L Standard Deviation 5.5	54.7 micrograms/L Standard Deviation 4.61	64.4 micrograms/L Standard Deviation 14
Dialysate InFlow Iron Concentration t = 1 hour	0 micrograms/L Standard Deviation 0	74 micrograms/L Standard Deviation 2.53	76.3 micrograms/L Standard Deviation 7.46	63.9 micrograms/L Standard Deviation 5.12	56.6 micrograms/L Standard Deviation 5.32	69.2 micrograms/L Standard Deviation 13.3
Dialysate InFlow Iron Concentration t = 2 hours	0.925 micrograms/L Standard Deviation 3.2	74.4 micrograms/L Standard Deviation 2.66	75.9 micrograms/L Standard Deviation 7.73	64.4 micrograms/L Standard Deviation 5.37	58.2 micrograms/L Standard Deviation 7.57	68.5 micrograms/L Standard Deviation 14
Dialysate InFlow Iron Concentration t = 3 hours	0 micrograms/L Standard Deviation 0	71.9 micrograms/L Standard Deviation 6.98	76.8 micrograms/L Standard Deviation 8.75	64.8 micrograms/L Standard Deviation 5.84	57.7 micrograms/L Standard Deviation 8.36	69.1 micrograms/L Standard Deviation 12.2
Dialysate InFlow Iron Concentration t = 4 hours	0 micrograms/L Standard Deviation 0	73.6 micrograms/L Standard Deviation 3.4	73.3 micrograms/L Standard Deviation 5.74	63.7 micrograms/L Standard Deviation 6.64	56.1 micrograms/L Standard Deviation 4.8	69.3 micrograms/L Standard Deviation 14.6

SECONDARY outcome

Timeframe: 4 hours

Dialysate outflow iron concentration was calculated for each treatment group at t = 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours.