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

Phase 4

Completed

• Conditions: Hyperphosphatemia; Hypoalbuminemia; Peritoneal Dialysis Complication
• Interventions: Drug: Sucroferric Oxyhydroxide Chewable Tablet

• Registration Number: NCT04046263
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-06
• Study Start: 2020-02-01
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Results First Submitted: 2022-07-13
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-09
• Last Update Submitted: 2022-08-09
• Results First Posted: 2022-08-31
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Sucroferric Oxyhydroxide Chewable Tablet	Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Serum PTH	Baseline, 6 months	Change in serum PTH (perathyroid hormone) from baseline to 6 months
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 Prealbumin	6 months	Change in prealbumin from baseline to 6 months

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States