Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
Primary Purpose
Peritoneal Dialysis Complication, Hyperphosphatemia, Hypoalbuminemia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sucroferric Oxyhydroxide Chewable Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Peritoneal Dialysis Complication
Eligibility 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
Sites / Locations
- University of Colorado Anschutz Medical Campus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal.
Outcomes
Primary Outcome Measures
Serum Phosphate at Baseline
Serum phosphate at baseline
Serum Phosphate at 6 Months
Serum phosphate at end of study (6 months)
Secondary Outcome Measures
Serum Albumin
Changes in serum albumin from baseline to 6 months
Serum FGF23
Change in serum FGF23 from baseline to 6 months
Serum PTH
Change in serum PTH (perathyroid hormone) from baseline to 6 months
Serum Prealbumin
Change in prealbumin from baseline to 6 months
Full Information
NCT ID
NCT04046263
First Posted
August 2, 2019
Last Updated
August 9, 2022
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT04046263
Brief Title
Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
Official Title
Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis Complication, Hyperphosphatemia, Hypoalbuminemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal.
Intervention Type
Drug
Intervention Name(s)
Sucroferric Oxyhydroxide Chewable Tablet
Intervention Description
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 Outcome Measure Information:
Title
Serum Phosphate at Baseline
Description
Serum phosphate at baseline
Time Frame
Baseline
Title
Serum Phosphate at 6 Months
Description
Serum phosphate at end of study (6 months)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Serum Albumin
Description
Changes in serum albumin from baseline to 6 months
Time Frame
Baseline, 6 months
Title
Serum FGF23
Description
Change in serum FGF23 from baseline to 6 months
Time Frame
6 months
Title
Serum PTH
Description
Change in serum PTH (perathyroid hormone) from baseline to 6 months
Time Frame
Baseline, 6 months
Title
Serum Prealbumin
Description
Change in prealbumin from baseline to 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Kendrick, MD
Organizational Affiliation
University of Colorado Denver | Anschutz
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
35810296
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
We'll reach out to this number within 24 hrs