End Stage Renal Disease (ESRD)
Conditions
Keywords
Hemodialysis
Brief summary
In maintenance hemodialysis patients, regular administration of parenteral iron by addition of soluble ferric pyrophosphate (SFP) to the dialysate, when compared to conventional dialysate, is effective in preventing the development of iron deficiency, thereby maintaining hemoglobin level; is clinically safe and does not lead to oxidative stress or inflammation.
Interventions
Subjects will be randomized to undergo dialysis with either Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL). Control concentrate lacking SFP (C-HD) does not contain SFP (total iron = 0)
OTHERplacebo
Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)
Sponsors
National Institutes of Health (NIH)
Rockwell Medical Technologies, Inc.
Charles Drew University of Medicine and Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects with end stage renal disease undergoing maintenance hemodialysis three times a week. * Subjects who have required IV iron at any time in the 2 months preceding enrollment.
Exclusion criteria
* Subjects with absolute iron deficiency at the time of enrollment In hemodialysis subjects absolute iron deficiency * Subjects with a current malignancy involving sites other than skin. * Subjects with a history of drug or alcohol abuse within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS | 36 weeks | Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of subjects affected are listed only. The details of the types of events that took place are reported in the Adverse Events section. |
| TOTAL NUMBER OF ADVERSE EVENTS | 36 weeks | Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of events are listed only. The details of the types of events that took place are reported in the Adverse Events section. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SFP Dialysate dialysate with added soluble ferric pyrophosphate (SFP)
soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL). | 4 |
| Standard Dialysate standard dialysate without soluble ferric pyrophosphate (SFP)
placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP) | 7 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated | 0 | 3 |
Baseline characteristics
| Characteristic | SFP Dialysate | Total | Standard Dialysate |
|---|---|---|---|
| Age, Continuous | 51.5 years | 54.0 years | 55.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 6 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 4 participants | 11 participants | 7 participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 4 | 7 / 7 |
| serious Total, serious adverse events | 0 / 4 | 1 / 7 |
Outcome results
Primary
TOTAL NUMBER OF ADVERSE EVENTS
Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of events are listed only. The details of the types of events that took place are reported in the Adverse Events section.
Time frame: 36 weeks
Population: All subjects were included in the Safety Analysis population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SFP Dialysate | TOTAL NUMBER OF ADVERSE EVENTS | Total Number of Serious Adverse Events (SAEs) | 0 events |
| SFP Dialysate | TOTAL NUMBER OF ADVERSE EVENTS | Total Number of Non-Serious Adverse Events | 66 events |
| Standard Dialysate | TOTAL NUMBER OF ADVERSE EVENTS | Total Number of Serious Adverse Events (SAEs) | 1 events |
| Standard Dialysate | TOTAL NUMBER OF ADVERSE EVENTS | Total Number of Non-Serious Adverse Events | 115 events |
Primary
TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS
Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of subjects affected are listed only. The details of the types of events that took place are reported in the Adverse Events section.
Time frame: 36 weeks
Population: All subjects were included in the Safety Analysis population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SFP Dialysate | TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS | Number of Subjects Who Experienced Serious AE | 0 participants |
| SFP Dialysate | TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS | Number of Subjects Who Experienced Non-serious AE | 4 participants |
| Standard Dialysate | TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS | Number of Subjects Who Experienced Non-serious AE | 7 participants |
| Standard Dialysate | TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS | Number of Subjects Who Experienced Serious AE | 1 participants |