Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 4

Conditions: Hypoalbuminemia; Peritoneal Dialysis Complication; Hyperphosphatemia

Treatments: Drug: Sucroferric Oxyhydroxide Chewable Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04046263

19-1027

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Intervention

Experimental group

Description:

Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal.

Treatment:

Drug: Sucroferric Oxyhydroxide Chewable Tablet