Status:
COMPLETED
Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
Lead Sponsor:
University of Colorado, Denver
Conditions:
Peritoneal Dialysis Complication
Hyperphosphatemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04046263
Start Date
February 1 2020
End Date
July 31 2021
Last Update
August 31 2022
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045