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

NCT04046263 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19-1027
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Dialysis Complication; Hyperphosphatemia; Hypoalbuminemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Serum Albumin

  Baseline, 6 months

• Serum FGF23

  6 months

• Serum PTH

  Baseline, 6 months

• Serum Prealbumin

  6 months

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Sucroferric Oxyhydroxide Chewable Tablet DRUG

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

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 35810296 DERIVED

MeSH Terms

Conditions

Hyperphosphatemia; Hypoalbuminemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

Study sample size is very small and there is no control group. This was due to complications that arose from the COVID-19 public health crisis.

Results Point of Contact

• Title: Jessica Kendrick, MD
• Organization: University of Colorado Denver | Anschutz

clinicalresearchsupportcenter@ucdenver.edu

303-724-1111

Study Officials

• Jessica Kendrick, MD

  University of Colorado Denver | Anschutz

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: February 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: August 31, 2022
• Results First Posted: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data will be available at the completion of the study. Researchers must obtain PI approval

Locations

US (1)