Clinical trial NCT03596749: The Effect of Sevelamer Carbonate on Serum Trimethylamine-n-Oxide (TMAO) Level in Patients With Chronic Kidney Disease (CKD) Stage 3b-4
Official title: The Effect of Sevelamer Carbonate on Serum Trimethylamine-n-Oxide (TMAO) Level in Patients With Chronic Kidney Disease (CKD) Stage 3b-4: a Protocol of a Randomized, Parallel, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: CKD Stage 3b
CKD Stage 4
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Difference in the serum concentration of TMAO between treatment group and control group
timeFrame: 22 weeks
Secondary outcomes:
measure: Difference in the serum concentration of p-cresyl sulfate between treatment group and control group
timeFrame: 22 weeks
measure: Difference in the serum concentration of indoxyl sulfate between treatment group and control group
timeFrame: 22 weeks
measure: Difference in the serum concentration of LDL-C between treatment group and control group
timeFrame: 22 weeks
measure: Difference in the serum concentration of uric acid between treatment group and control group
timeFrame: 22 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Renal Division, Nanfang Hospital,Southern Medical University
state: Guangdong
Study officials:
affiliation: Division of nephrology, Nanfang Hospital Southern Medical University
name: Fan Fan Hou, M.D.,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Yubero-Serrano EM, Woodward M, Poretsky L, Vlassara H, Striker GE; AGE-less Study Group. Effects of sevelamer carbonate on advanced glycation end products and antioxidant/pro-oxidant status in patients with diabetic kidney disease. Clin J Am Soc Nephrol. 2015 May 7;10(5):759-66. doi: 10.2215/CJN.07750814. Epub 2015 Feb 20.
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