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

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.

Study Overview

• Status: Completed
• Conditions: Hyperphosphatemia; Hypoalbuminemia; Peritoneal Dialysis Complication
• Intervention / Treatment: Drug: Sucroferric Oxyhydroxide Chewable Tablet

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Phosphate at Baseline	Serum phosphate at baseline	Baseline
Serum Phosphate at 6 Months	Serum phosphate at end of study (6 months)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Albumin	Changes in serum albumin from baseline to 6 months	Baseline, 6 months
Serum FGF23	Change in serum FGF23 from baseline to 6 months	6 months
Serum PTH	Change in serum PTH (perathyroid hormone) from baseline to 6 months	Baseline, 6 months
Serum Prealbumin	Change in prealbumin from baseline to 6 months	6 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jessica Kendrick, MD, University of Colorado Denver | Anschutz

Publications and helpful links

General Publications

• Perez L, You Z, Teitelbaum I, Andrews ES, Reddin R, Ramirez-Renteria L, Wilson G, Kendrick J. A 6-Month clinical practice pilot study of sucroferric oxyhydroxide on nutritional status in patients on peritoneal dialysis. BMC Nephrol. 2022 Jul 9;23(1):245. doi: 10.1186/s12882-022-02878-5.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Blood Protein Disorders; Phosphorus Metabolism Disorders; Hypoproteinemia; Hyperphosphatemia; Hypoalbuminemia; Hematinics; Ferric Compounds
• Other Study ID Numbers: 19-1027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: At the end of the study deidentified data will be available to other researchers
• IPD Sharing Time Frame: Data will be available at the completion of the study. Researchers must obtain PI approval
• IPD Sharing Supporting Information Type: Study Protocol; Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes