Protein-bound uremic toxin lowering effects of sevelamer in end-stage kidney disease receiving hemodialysis with hyperphosphatemia: a randomized controlled trial

Phase 4

Completed

• Conditions: Protein-bound uremic toxinEnd stage kidney disease receiving hemodialysis; Sevelamer; Calcium carbonate; Phosphate binder; Protein-bound uremic toxin; p-cresyl sulfate; Indoxyl sulfate; Cardio-ankle vascular index (CAVI); End stage renal disease; Hemodialysis

• Registration Number: TCTR20230530004
• Lead Sponsor: Faculty of medicine, CHulalongkorn university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-30
• Study Completion: 2024-06-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Age more than 18 years old
2. Chronic kidney disease receiving hemodialysis for more than 3 months
3. Hyperphosphatemia at least 5.5 mg/dL or currently receiving phosphate binders
4. Consent to the study

Exclusion Criteria

1. Severe vascular calcification defined as symptomatic peripheral vascular disease, history of amputation due to peripheral vascular occlusion, recent cerebrovascular disease within 6 months and calciphylaxis
2. Baseline serum calcium more than 10.0 mg/dL before randomisation
3. Untreated secondary or tertiary hyperparathyroidism with PTH more than 1000 pg/mL
4. Pregnancy
5. Recent any routes on antibiotics within 2 weeks
6. Planned kidney transplantation within 6 months
7. Patients with terminal illness, life expectancy less than 6 months
8. Active infection or active malignancies
9. Likely to non-compliance
10. Patients receiving hemodiafiltration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
p-cresyl sulfate change 24 weeks blood sample using high-performance liquid chromatography

Secondary Outcome Measures

Name	Time	Method
Indoxyl sulfate change 24 weeks blood sample using high-performance liquid chromatography,high sensitivity C-reactive protein change 24 weeks blood sample using nephelometer,intact parathyroid hormone change 24 weeks Electrochemiluminescence immunoassay,cardio-ankle vascular index (CAVI) change 24 weeks non-invasive blood pressure and phonocardiography