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

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT04046263
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Actual Duration (Months): 19.9
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peritoneal Dialysis Complication; Hyperphosphatemia; Hypoalbuminemia	Drug: Sucroferric Oxyhydroxide Chewable Tablet	Phase 4

Study Design

• Study Type: Interventional
• 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: Feb 1, 2020
• Actual Primary Completion Date: Jul 31, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

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

Primary Outcome Measures

1. Serum phosphate [6 months]

   Changes in serum phosphate from baseline to 6 months

Secondary Outcome Measures

1. Serum albumin [6 months]

   Changes in serum albumin from baseline to 6 months

2. Serum FGF23 [6 months]

   Change in serum FGF23 from baseline to 6 months

3. Serum PTH [6 months]

   Change in serum PTH from baseline to 6 months

4. Serum prealbumin [6 months]

   Change in prealbumin from baseline to 6 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT04046263
• Other Study ID Numbers: 19-1027
• First Posted: Aug 6, 2019
• Last Update Posted: Oct 12, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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: Hypoalbuminemia; Hyperphosphatemia; Ferric Compounds

Study Results

No Results Posted as of Oct 12, 2021