Hyperphosphatemia, Hypoalbuminemia, Peritoneal Dialysis Complication
Conditions
Brief summary
Prospective pilot study to determine if changing the phosphate binder to sucroferric oxyhydroxide for for 6 months improves disordered mineral metabolism and nutrition status in peritoneal dialysis patients.
Interventions
Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * On peritoneal dialysis at least 3 months with a Kt/V of ≥ 1.7 * Use of Automated Peritoneal Dialysis * Serum phosphate \> 5.5 mg/dL or \<5.5 mg/dL on a binder other than velphoro * Serum albumin ≤ 3.7 g/dL * Able to provide consent * Ability to complete self-reported questionnaire
Exclusion criteria
* Inadequate dialysis * Current use of sucroferric oxyhydroxide * Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 6 months * Active malignancy * Recent episode of peritonitis * Pregnancy or planning to become pregnant * Anticipated kidney transplantation within 6 months * Factors judged to limit adherence to interventions * Known adverse side effect to sucroferric oxydroxide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Phosphate at Baseline | Baseline | Serum phosphate at baseline |
| Serum Phosphate at 6 Months | 6 months | Serum phosphate at end of study (6 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Albumin | Baseline, 6 months | Changes in serum albumin from baseline to 6 months |
| Serum FGF23 | 6 months | Change in serum FGF23 from baseline to 6 months |
| Serum PTH | Baseline, 6 months | Change in serum PTH (perathyroid hormone) from baseline to 6 months |
| Serum Prealbumin | 6 months | Change in prealbumin from baseline to 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal.
Sucroferric Oxyhydroxide Chewable Tablet: Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 17 |
| other Total, other adverse events | 9 / 17 |
| serious Total, serious adverse events | 2 / 17 |
Outcome results
Primary
Serum Phosphate at 6 Months
Serum phosphate at end of study (6 months)
Time frame: 6 months
Population: Outcome measure data could not be collected for all participants at the 6 month timepoint due to some participants discontinuing the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Serum Phosphate at 6 Months | 5.69 mg/dL | Standard Deviation 1.17 |
Primary
Serum Phosphate at Baseline
Serum phosphate at baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Serum Phosphate at Baseline | 7.47 mg/dL | Standard Deviation 1.76 |
Secondary
Serum Albumin
Changes in serum albumin from baseline to 6 months
Time frame: Baseline, 6 months
Population: Outcome measure data could not be collected for all participants at the 6 month timepoint due to some participants discontinuing the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Serum Albumin | Baseline | 3.49 g/dL | Standard Deviation 0.37 |
| Intervention | Serum Albumin | 6 Months | 3.50 g/dL | Standard Deviation 0.27 |
Secondary
Serum FGF23
Change in serum FGF23 from baseline to 6 months
Time frame: 6 months
Population: This outcome measure could not be collected due to unforeseen changes in the study capability caused by the COVID-19 public health crisis.
Secondary
Serum Prealbumin
Change in prealbumin from baseline to 6 months
Time frame: 6 months
Population: This outcome measure could not be collected due to unforeseen changes in the study capability caused by the COVID-19 public health crisis.
Secondary
Serum PTH
Change in serum PTH (perathyroid hormone) from baseline to 6 months
Time frame: Baseline, 6 months
Population: Outcome measure data could not be collected for all participants at the 6 month timepoint due to some participants discontinuing the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Serum PTH | Baseline | 416 picograms/mL |
| Intervention | Serum PTH | 6 Months | 361 picograms/mL |