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

August 3, 2018 updated by: Fan Fan Hou

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Renal Division, Nanfang Hospital,Southern Medical University
        • Contact:
        • Principal Investigator:
          • Fan Fan Hou, M.D., Ph.D.
        • Sub-Investigator:
          • Sheng Nie, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
22 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
22 weeks
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)
22 weeks
Difference in the serum concentration of LDL-C between treatment group and control group
Time Frame: 22 weeks
Chemistry evaluations
22 weeks
Difference in the serum concentration of uric acid between treatment group and control group
Time Frame: 22 weeks
Chemistry evaluations
22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fan Fan Hou

Investigators

  • Principal Investigator: Fan Fan Hou, M.D.,PhD, Division of nephrology, Nanfang Hospital Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

July 12, 2018

First Posted (Actual)

July 24, 2018

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 3, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIMON

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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