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

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ClinicalTrials.gov Identifier: NCT03596749
Recruitment Status : Unknown
Verified August 2018 by Fan Fan Hou, Nanfang Hospital of Southern Medical University.
Recruitment status was:  Not yet recruiting
First Posted : July 24, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Fan Fan Hou, Nanfang Hospital of Southern Medical University

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.

Condition or disease Intervention/treatment Phase
CKD Stage 3b CKD Stage 4 Drug: Sevelamer Carbonate Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Sevelamer Carbonate
Sevelamer carbonate will be given with fixed dose of 1600mg (p.o. b.i.d) with meals
Drug: Sevelamer Carbonate
Sevelamer carbonate 1600mg (p.o. b.i.d) with meals

No Intervention: Control
blank-control



Primary Outcome Measures :
  1. Difference in the serum concentration of TMAO between treatment group and control group [ Time Frame: 22 weeks ]
    The serum concentration of TMAO will be evaluated by high performance liquid chromatography (HPLC)


Secondary Outcome Measures :
  1. Difference in the serum concentration of p-cresyl sulfate between treatment group and control group [ Time Frame: 22 weeks ]
    The serum concentration of p-cresyl sulfate will be evaluated by high performance liquid chromatography (HPLC)

  2. Difference in the serum concentration of indoxyl sulfate between treatment group and control group [ Time Frame: 22 weeks ]
    The serum concentration of indoxyl sulfate will be evaluated by high performance liquid chromatography (HPLC)

  3. Difference in the serum concentration of LDL-C between treatment group and control group [ Time Frame: 22 weeks ]
    Chemistry evaluations

  4. Difference in the serum concentration of uric acid between treatment group and control group [ Time Frame: 22 weeks ]
    Chemistry evaluations



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596749


Contacts
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Contact: Fan Fan Hou, M.D.,PhD 0086-20-61641591 ffhouguangzhou@163.com

Locations
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China, Guangdong
Renal Division, Nanfang Hospital,Southern Medical University
Guangzhou, Guangdong, China, 510515
Contact: Fan Fan Hou, M.D., Ph.D.    86-20-61641597    ffhou@public.guangzhou.gd.cn   
Principal Investigator: Fan Fan Hou, M.D., Ph.D.         
Sub-Investigator: Sheng Nie, M.D.         
Sponsors and Collaborators
Fan Fan Hou
Investigators
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Principal Investigator: Fan Fan Hou, M.D.,PhD Division of nephrology, Nanfang Hospital Southern Medical University
Publications:

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Responsible Party: Fan Fan Hou, Chief of Division of Nephrology, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03596749    
Other Study ID Numbers: SIMON
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Sevelamer
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action