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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230530004

Enrollment

140

Registered

2023-05-30

Start date

2023-07-25

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protein-bound uremic toxin End 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

Interventions

Sevelamer (800 mg per tab) 1 to 3 tabs per oral thrice daily,Calcium carbonate (1000 mg per tab) 0.5 to 1.5 tabs per oral thrice daily

Experimental Drug,Active Comparator Drug

Sevelamer carbonate,Calcium carbonate

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
p-cresyl sulfate change 24 weeks blood sample using high-performance liquid chromatography	—

Secondary

Measure	Time frame
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	—

Countries

Thailand

Contacts

Public ContactNapas Srifa

Faculty of medicine, Chulalongkorn university

khun_cc@hotmail.com0814166083

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026