Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevelamer Carbonate | Experimental | Sevelamer carbonate will be given with fixed dose of 1600mg (p.o. b.i.d) with meals |
|
| Control | No Intervention | blank-control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevelamer Carbonate | Drug | Sevelamer carbonate 1600mg (p.o. b.i.d) with meals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the serum concentration of TMAO between treatment group and control group | The serum concentration of TMAO will be evaluated by high performance liquid chromatography (HPLC) | 22 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the serum concentration of p-cresyl sulfate between treatment group and control group | The serum concentration of p-cresyl sulfate will be evaluated by high performance liquid chromatography (HPLC) | 22 weeks |
| Difference in the serum concentration of indoxyl sulfate between treatment group and control group |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fan Fan Hou, M.D.,PhD | Contact | 0086-20-61641591 | ffhouguangzhou@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fan Fan Hou, M.D.,PhD | Division of nephrology, Nanfang Hospital Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renal Division, Nanfang Hospital,Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22386035 | Background | Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, Chen M, He Q, Liao Y, Yu X, Chen N, Zhang JE, Hu Z, Liu F, Hong D, Ma L, Liu H, Zhou X, Chen J, Pan L, Chen W, Wang W, Li X, Wang H. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012 Mar 3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6. | |
| 15385656 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The serum concentration of indoxyl sulfate will be evaluated by high performance liquid chromatography (HPLC) |
| 22 weeks |
| Difference in the serum concentration of LDL-C between treatment group and control group | Chemistry evaluations | 22 weeks |
| Difference in the serum concentration of uric acid between treatment group and control group | Chemistry evaluations | 22 weeks |
| Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031. |
| 27887750 | Background | Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney Disease. Lancet. 2017 Mar 25;389(10075):1238-1252. doi: 10.1016/S0140-6736(16)32064-5. Epub 2016 Nov 23. |
| 21426503 | Background | Goto S, Yoshiya K, Kita T, Fujii H, Fukagawa M. Uremic toxins and oral adsorbents. Ther Apher Dial. 2011 Apr;15(2):132-4. doi: 10.1111/j.1744-9987.2010.00891.x. Epub 2011 Mar 8. |
| 25599331 | Background | Tang WH, Wang Z, Kennedy DJ, Wu Y, Buffa JA, Agatisa-Boyle B, Li XS, Levison BS, Hazen SL. Gut microbiota-dependent trimethylamine N-oxide (TMAO) pathway contributes to both development of renal insufficiency and mortality risk in chronic kidney disease. Circ Res. 2015 Jan 30;116(3):448-55. doi: 10.1161/CIRCRESAHA.116.305360. Epub 2014 Nov 5. |
| 25710801 | Background | 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. |
| 22461535 | Background | Vlassara H, Uribarri J, Cai W, Goodman S, Pyzik R, Post J, Grosjean F, Woodward M, Striker GE. Effects of sevelamer on HbA1c, inflammation, and advanced glycation end products in diabetic kidney disease. Clin J Am Soc Nephrol. 2012 Jun;7(6):934-42. doi: 10.2215/CJN.12891211. Epub 2012 Mar 29. |
| 24327730 | Background | Rastogi A. Sevelamer revisited: pleiotropic effects on endothelial and cardiovascular risk factors in chronic kidney disease and end-stage renal disease. Ther Adv Cardiovasc Dis. 2013 Dec;7(6):322-42. doi: 10.1177/1753944713513061. |
| 27676197 | Background | Koopen AM, Groen AK, Nieuwdorp M. Human microbiome as therapeutic intervention target to reduce cardiovascular disease risk. Curr Opin Lipidol. 2016 Dec;27(6):615-622. doi: 10.1097/MOL.0000000000000357. |
| 28919117 | Background | GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2. |