Phase 4
Completed N=17
Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
Peritoneal Dialysis Complication · Hyperphosphatemia · Hypoalbuminemia
Source: ClinicalTrials.gov NCT04046263 ↗
Enrolled (actual)
17
Serious AEs
11.8%
Results posted
Aug 2022
Primary outcomePrimary: Serum Phosphate at Baseline — 7.47 mg/dL
◆ Published Evidence
Emerging
5citations · ~1 / year
A 6-Month clinical practice pilot study of sucroferric oxyhydroxide on nutritional status in patients on peritoneal dialysis.
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.
Linked Publications
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A 6-Month clinical practice pilot study of sucroferric oxyhydroxide on nutritional status in patients on peritoneal dialysis.
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 |
— | — |
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) and the linked publication. 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. Informational only — not medical advice.