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

Phase 3

• Conditions: CKD Stage 4; CKD Stage 3b
• Interventions: Drug: Sevelamer Carbonate

• Registration Number: NCT03596749
• Lead Sponsor: Fan Fan Hou

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-24
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-03
• Last Update Posted: 2018-08-07
• Study Start: 2018-09-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevelamer Carbonate	Sevelamer Carbonate	Sevelamer carbonate will be given with fixed dose of 1600mg (p.o. b.i.d) with meals

Primary Outcome Measures

Name	Time	Method
Difference in the serum concentration of TMAO between treatment group and control group	22 weeks	The serum concentration of TMAO will be evaluated by high performance liquid chromatography (HPLC)

Secondary Outcome Measures

Name	Time	Method
Difference in the serum concentration of indoxyl sulfate between treatment group and control group	22 weeks	The serum concentration of indoxyl sulfate will be evaluated by high performance liquid chromatography (HPLC)
Difference in the serum concentration of p-cresyl sulfate between treatment group and control group	22 weeks	The serum concentration of p-cresyl sulfate will be evaluated by high performance liquid chromatography (HPLC)
Difference in the serum concentration of LDL-C between treatment group and control group	22 weeks	Chemistry evaluations
Difference in the serum concentration of uric acid between treatment group and control group	22 weeks	Chemistry evaluations

Trial Locations

Locations (1)

Renal Division, Nanfang Hospital,Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China