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CKD Stage 3bPhase 3NCT03596749

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

A Phase 3 study testing Sevelamer Carbonate in people with CKD Stage 3b and CKD Stage 4, run by Fan Fan Hou at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
CKD Stage 3b, CKD Stage 4
What is being tested?
Sevelamer Carbonate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
1 Sep 2018to 1 Jul 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Fan Fan Hou, M.D.,PhD contact

0086-20-61641591

ffhouguangzhou@163.com

China1 site

  • Renal Division, Nanfang Hospital,Southern Medical University

    Guangzhou, Guangdong, 510515

    Fan Fan Hou, M.D., Ph.D., 86-20-61641597, ffhou@public.guangzhou.gd.cn

    Fan Fan Hou, M.D., Ph.D.

Other trials in China

About this study

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

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.

Being tested
Sevelamer Carbonate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sevelamer CarbonateDrug

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

Study groups in NCT03596749
Study groupRoleWhat they receive
Sevelamer CarbonateExperimentalSevelamer carbonate will be given with fixed dose of 1600mg (p.o. b.i.d) with meals
Receives: Drug: Sevelamer Carbonate
ControlNo interventionblank-control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 22 weeks

Secondary outcomes (4)

  1. 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)

    Measured: 22 weeks

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

    The serum concentration of indoxyl sulfate will be evaluated by high performance liquid chromatography (HPLC)

    Measured: 22 weeks

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

    Chemistry evaluations

    Measured: 22 weeks

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

    Chemistry evaluations

    Measured: 22 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2018
  2. Study start1 Sep 2018 (estimated)
  3. Primary completion1 May 2019 (estimated)
  4. Study completion1 Jul 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03596749
Sponsor's protocol ID
SIMON
Status last verified
Aug 2018
First submitted
12 Jul 2018
Last updated
7 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 22386035

  • 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.

    PubMed 15385656

  • 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.

    PubMed 27887750

  • 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.

    PubMed 21426503

  • 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.

    PubMed 25599331

  • 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.

    PubMed 25710801

  • 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.

    PubMed 22461535

  • 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.

    PubMed 24327730

  • 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.

    PubMed 27676197

  • 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.

    PubMed 28919117

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sevelamer Carbonate in people with CKD Stage 3b and CKD Stage 4, run by Fan Fan Hou at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fan Fan Hou, M.D.,PhD (0086-20-61641591, ffhouguangzhou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the serum concentration of TMAO between treatment group and control group (time frame: 22 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03596749, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.

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