The Effect of Sevelamer Carbonate on Serum Trimethylamine-n-Oxide (TMAO) Level in Patients With Chronic Kidney Disease (CKD) Stage 3b-4

• Status: Unknown status
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to investigate effects of sevelamer carbonate on reducing TMAO in stage 3b-4 CKD (pre-dialysis) patients. The study will also investigate the safety and tolerability of sevelamer carbonate in study population and the effects of sevelamer carbonate on serum p-cresyl sulfate, indoxyl sulfate, LDL-C and uric acid.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fan Fan Hou
• Treatments: Sevelamer

Criteria

Inclusion Criteria:

• 1. Men or women, aged from 18 to 75 years old;

• 2. Provide informed consent prior to enrolling in the study;

• 3. Estimated glomerular filtration rate (eGFR) between 15-45 ml/min/1.73 m2 (calculated by CKD-EPI equation)

Exclusion Criteria:

• 1. Documented poorly controlled diabetes mellitus, poorly controlled hypertension, malignant tumour, or any clinically significant unstable medical condition;

• 2. Active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation;

• 3. Known hypersensitivity to sevelamer or any constituents of the study drug;

• 4. Unable to comply with the requirements of the study;

• 5. Hypophosphatemia (serum phosphorus level <0.87mmol/L);

• 6. Women who have a positive pregnancy test at enrollment or women who are breast-feeding;

• 7. Have been enrolled in other interventional study;

• 8. Received sevelamer or other intestinal adsorbents, or broad-spectrum antibiotic within one month prior to the screening period.