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Completed

NCT Number: NCT04046263

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.

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Key information

Conditions

Peritoneal Dialysis Complication Blood Protein Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hyperphosphatemia Hypoalbuminemia Hypoproteinemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Serum Phosphate at Baseline

    Time frame: Baseline

    Serum phosphate at baseline

  2. Serum Phosphate at 6 Months

    Time frame: 6 months

    Serum phosphate at end of study (6 months)

Secondary outcomes

  1. Serum Albumin

    Time frame: Baseline, 6 months

    Changes in serum albumin from baseline to 6 months

  2. Serum FGF23

    Time frame: 6 months

    Change in serum FGF23 from baseline to 6 months

  3. Serum PTH

    Time frame: Baseline, 6 months

    Change in serum PTH (perathyroid hormone) from baseline to 6 months

  4. Serum Prealbumin

    Time frame: 6 months

    Change in prealbumin from baseline to 6 months

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 6, 2019
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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