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

Fan Fan Hou

Status and phase

Unknown

Phase 3

Conditions

CKD Stage 3b

CKD Stage 4

Treatments

Drug: Sevelamer Carbonate

Study type

Interventional

Funder types

Other

Identifiers

NCT03596749

SIMON

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Men or women, aged from 18 to 75 years old;
1. Provide informed consent prior to enrolling in the study;
1. 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;
1. Active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation;
1. Known hypersensitivity to sevelamer or any constituents of the study drug;
1. Unable to comply with the requirements of the study;
1. Hypophosphatemia (serum phosphorus level <0.87mmol/L);
1. Women who have a positive pregnancy test at enrollment or women who are breast-feeding;
1. Have been enrolled in other interventional study;
1. Received sevelamer or other intestinal adsorbents, or broad-spectrum antibiotic within one month prior to the screening period.