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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucroferric Oxyhydroxide Chewable Tablet | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Phosphate at Baseline | Serum phosphate at baseline | Baseline |
| Serum Phosphate at 6 Months | Serum phosphate at end of study (6 months) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Albumin | Changes in serum albumin from baseline to 6 months | Baseline, 6 months |
| Serum FGF23 | Change in serum FGF23 from baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Kendrick, MD | University of Colorado Denver | Anschutz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35810296 | Derived | Perez L, You Z, Teitelbaum I, Andrews ES, Reddin R, Ramirez-Renteria L, Wilson G, Kendrick J. A 6-Month clinical practice pilot study of sucroferric oxyhydroxide on nutritional status in patients on peritoneal dialysis. BMC Nephrol. 2022 Jul 9;23(1):245. doi: 10.1186/s12882-022-02878-5. |
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At the end of the study deidentified data will be available to other researchers
Data will be available at the completion of the study. Researchers must obtain PI approval
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| ID | Title | Description |
|---|---|---|
| FG000 | Sucroferric Oxyhydroxide | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Phosphate at Baseline | Serum phosphate at baseline | Posted | Mean | Standard Deviation | mg/dL | Baseline |
|
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Up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Non-systematic Assessment | 2 participants died, likely due to COVID-19. Was determined not to be study related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI symptoms | Gastrointestinal disorders | Systematic Assessment | includes common GI symptoms such as nausea & vomiting. |
Study sample size is very small and there is no control group. This was due to complications that arose from the COVID-19 public health crisis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Kendrick, MD | University of Colorado Denver | Anschutz | 303-724-1111 | clinicalresearchsupportcenter@ucdenver.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2020 | Jul 13, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| D034141 | Hypoalbuminemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007019 | Hypoproteinemia |
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| 6 months |
| Serum PTH | Change in serum PTH (perathyroid hormone) from baseline to 6 months | Baseline, 6 months |
| Serum Prealbumin | Change in prealbumin from baseline to 6 months | 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| Primary | Serum Phosphate at 6 Months | Serum phosphate at end of study (6 months) | Outcome measure data could not be collected for all participants at the 6 month timepoint due to some participants discontinuing the study. | Posted | Mean | Standard Deviation | mg/dL | 6 months |
|
|
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| Secondary | Serum Albumin | Changes in serum albumin from baseline to 6 months | Outcome measure data could not be collected for all participants at the 6 month timepoint due to some participants discontinuing the study. | Posted | Mean | Standard Deviation | g/dL | Baseline, 6 months |
|
|
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| Secondary | Serum FGF23 | Change in serum FGF23 from baseline to 6 months | This outcome measure could not be collected due to unforeseen changes in the study capability caused by the COVID-19 public health crisis. | Posted | 6 months |
|
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| Secondary | Serum PTH | Change in serum PTH (perathyroid hormone) from baseline to 6 months | Outcome measure data could not be collected for all participants at the 6 month timepoint due to some participants discontinuing the study. | Posted | Median | Inter-Quartile Range | picograms/mL | Baseline, 6 months |
|
|
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| Secondary | Serum Prealbumin | Change in prealbumin from baseline to 6 months | This outcome measure could not be collected due to unforeseen changes in the study capability caused by the COVID-19 public health crisis. | Posted | 6 months |
|
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| 2 |
| 17 |
| 2 |
| 17 |
| 9 |
| 17 |
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| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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