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Comparison Of Protein-bound Uremic Toxins Lowering Effect Of Ferric Citrate Versus Sevelamer In Pre-Dialysis Chronic Kidney Disease Patients With Hyperphosphatemia: A Randomized Controlled Trial

Comparison Of Protein-bound Uremic Toxins Lowering Effect Of Ferric Citrate Versus Sevelamer In Pre-Dialysis Chronic Kidney Disease Patients With Hyperphosphatemia: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260306004
Enrollment
80
Registered
2026-03-06
Start date
2025-05-15
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

Is ferric citrate non-inferior to sevelamer to lower protein uremic toxins in pre-dialysis CKD with hyperphosphatemia? Protein-bound uremic toxin Sevelamer Ferric citrate Chronic kidney disease

Interventions

Ferric citrate group: (500 mg/tab) Patients with serum phosphate 4.5-4.9 mg/dL, will receive Ferric citrate 1000 mg after each meal, three times daily. Total 3000 mg per day. Patients with serum phosp
Active Comparator Drug,Placebo Comparator Drug
Ferric citrate,Sevelamer

Sponsors

Thai Red Cross Society Research Fund
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. Adult (age 18-80 years) 2. Pre-dialysis CKD eGFR less than 60 ml/min/1.73m2 by CKD-EPI creatinine equation 3. Hyperphosphatemia (Serum phosphate more than 4.5 mg/dL) without phosphate-binding agents or after 1 week washout

Exclusion criteria

Exclusion criteria: 1. Received sevelamer before 2. Serum ferritin more than 800 ng/mL or TSAT more than 40% 3. Hemochromatosis 4. Pregnancy 5. History of gastrointestinal bleeding in 6 months 6. Previous antibiotic use in 2 weeks 7. Previous biotic supplement in 2 weeks 8. Previous IV or oral iron supplement in 2 weeks

Design outcomes

Primary

MeasureTime frame
P-cresyl sulfate 1 month responder rate

Secondary

MeasureTime frame
Indoxyl sulfate, Fibroblast growth factor23 1 month level

Countries

Thailand

Contacts

Public ContactWannee Jiamjaipaiboon

King Chulalongkorn Memorial Hospital

mai_asc95@hotmail.com0926984451

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026