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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04046263
Recruitment Status : Completed
First Posted : August 6, 2019
Results First Posted : August 31, 2022
Last Update Posted : August 31, 2022
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peritoneal Dialysis Complication Hyperphosphatemia Hypoalbuminemia Drug: Sucroferric Oxyhydroxide Chewable Tablet Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
Actual Study Start Date : February 1, 2020
Actual Primary Completion Date : July 31, 2021
Actual Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046263


Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Jessica Kendrick, MD University of Colorado Denver | Anschutz
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Study Protocol and Statistical Analysis Plan  [PDF] January 30, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04046263    
Other Study ID Numbers: 19-1027
First Posted: August 6, 2019    Key Record Dates
Results First Posted: August 31, 2022
Last Update Posted: August 31, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At the end of the study deidentified data will be available to other researchers
Supporting Materials: Study Protocol
Analytic Code
Time Frame: Data will be available at the completion of the study. Researchers must obtain PI approval

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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
Additional relevant MeSH terms:
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Hypoalbuminemia
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Hypoproteinemia
 Blood Protein Disorders
Hematologic Diseases
Ferric Compounds
Hematinics