Phase 4
N=17
Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
Peritoneal Dialysis Complication · Hyperphosphatemia · Hypoalbuminemia
Bottom Line
View on ClinicalTrials.gov: NCT04046263 ↗Enrolled (actual)
17
Serious AEs
11.8%
Results posted
Aug 2022
Primary outcome: Primary: Serum Phosphate at Baseline — 7.47 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sucroferric Oxyhydroxide Chewable Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Phosphate at Baseline |
7.47 | — |
| PRIMARY Serum Phosphate at 6 Months |
5.69 | — |
| SECONDARY Serum Albumin |
3.49; 3.50 | — |
| SECONDARY Serum FGF23 |
— | — |
| SECONDARY Serum PTH |
416; 361 | — |
| SECONDARY Serum Prealbumin |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04046263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.