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

Hyperphosphatemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04046263
• Other study ID #: 19-1027
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperphosphatemia
• Hypoalbuminemia
• Peritoneal Dialysis Complication

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Phosphate at Baseline	Serum phosphate at baseline	Baseline
Primary	Serum Phosphate at 6 Months	Serum phosphate at end of study (6 months)	6 months
Secondary	Serum Albumin	Changes in serum albumin from baseline to 6 months	Baseline, 6 months
Secondary	Serum FGF23	Change in serum FGF23 from baseline to 6 months	6 months
Secondary	Serum PTH	Change in serum PTH (perathyroid hormone) from baseline to 6 months	Baseline, 6 months
Secondary	Serum Prealbumin	Change in prealbumin from baseline to 6 months	6 months