NCT03596749

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

July 12, 2018

Last Update Submit

August 3, 2018

Conditions

CKD Stage 3bCKD Stage 4

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Difference in the serum concentration of p-cresyl sulfate between treatment group and control group

    22 weeks

  • Difference in the serum concentration of indoxyl sulfate between treatment group and control group

    22 weeks

  • Difference in the serum concentration of LDL-C between treatment group and control group

    22 weeks

  • Difference in the serum concentration of uric acid between treatment group and control group

    22 weeks

Study Arms (2)

Sevelamer Carbonate

EXPERIMENTAL

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

Drug: Sevelamer Carbonate

Control

NO INTERVENTION

blank-control

Interventions

Sevelamer CarbonateDRUG

Sevelamer carbonate 1600mg (p.o. b.i.d) with meals

Sevelamer Carbonate

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Men or women, aged from 18 to 75 years old;
  • \. Provide informed consent prior to enrolling in the study;
  • \. Estimated glomerular filtration rate (eGFR) between 15-45 ml/min/1.73 m2 (calculated by CKD-EPI equation)

You may not qualify if:

  • \. Documented poorly controlled diabetes mellitus, poorly controlled hypertension, malignant tumour, or any clinically significant unstable medical condition;
  • \. Active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation;
  • \. Known hypersensitivity to sevelamer or any constituents of the study drug;
  • \. Unable to comply with the requirements of the study;
  • \. Hypophosphatemia (serum phosphorus level \<0.87mmol/L);
  • \. Women who have a positive pregnancy test at enrollment or women who are breast-feeding;
  • \. Have been enrolled in other interventional study;
  • \. Received sevelamer or other intestinal adsorbents, or broad-spectrum antibiotic within one month prior to the screening period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renal Division, Nanfang Hospital,Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (10)

  • 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.

    PMID: 22386035BACKGROUND

  • 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.

    PMID: 15385656BACKGROUND

  • 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.

    PMID: 27887750BACKGROUND

  • 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.

    PMID: 21426503BACKGROUND

  • 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.

    PMID: 25599331BACKGROUND

  • 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.

    PMID: 25710801BACKGROUND

  • 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.

    PMID: 22461535BACKGROUND

  • 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.

    PMID: 24327730BACKGROUND

  • 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.

    PMID: 27676197BACKGROUND

  • 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.

    PMID: 28919117BACKGROUND

MeSH Terms

Interventions

Sevelamer

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic Chemicals

Study Officials

  • Fan Fan Hou, M.D.,PhD

    Division of nephrology, Nanfang Hospital Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fan Fan Hou, M.D.,PhD

CONTACT

0086-20-61641591ffhouguangzhou@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of Division of Nephrology

Study Record Dates

First Submitted

July 12, 2018

First Posted

July 24, 2018

Study Start

September 1, 2018

Primary Completion

May 1, 2019

Study Completion

July 1, 2019

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

CN(1)