Back to resultsThe Effect of Sevelamer Carbonate on Serum Trimethylamine-n-Oxide (TMAO) Level in Patients With Chronic Kidney Disease (CKD) Stage 3b-4
Primary Purpose
CKD Stage 3b, CKD Stage 4
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Sevelamer Carbonate
Sponsored by
About this trial
This is an interventional treatment trial for CKD Stage 3b
Eligibility 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.
Sites / Locations
- Renal Division, Nanfang Hospital,Southern Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sevelamer Carbonate
Control
Arm Description
Sevelamer carbonate will be given with fixed dose of 1600mg (p.o. b.i.d) with meals
blank-control
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
Difference in the serum concentration of LDL-C between treatment group and control group
Chemistry evaluations
Difference in the serum concentration of uric acid between treatment group and control group
Chemistry evaluations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03596749
Brief Title
The Effect of Sevelamer Carbonate on Serum Trimethylamine-n-Oxide (TMAO) Level in Patients With Chronic Kidney Disease (CKD) Stage 3b-4
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
July 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fan Fan Hou
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CKD Stage 3b, CKD Stage 4
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sevelamer Carbonate
Arm Type
Experimental
Arm Description
Sevelamer carbonate will be given with fixed dose of 1600mg (p.o. b.i.d) with meals
Arm Title
Control
Arm Type
No Intervention
Arm Description
blank-control
Intervention Type
Drug
Intervention Name(s)
Sevelamer Carbonate
Intervention Description
Sevelamer carbonate 1600mg (p.o. b.i.d) with meals
Primary Outcome Measure Information:
Title
Difference in the serum concentration of TMAO between treatment group and control group
Description
The serum concentration of TMAO will be evaluated by high performance liquid chromatography (HPLC)
Time Frame
22 weeks
Secondary Outcome Measure Information:
Title
Difference in the serum concentration of p-cresyl sulfate between treatment group and control group
Description
The serum concentration of p-cresyl sulfate will be evaluated by high performance liquid chromatography (HPLC)
Time Frame
22 weeks
Title
Difference in the serum concentration of indoxyl sulfate between treatment group and control group
Description
The serum concentration of indoxyl sulfate will be evaluated by high performance liquid chromatography (HPLC)
Time Frame
22 weeks
Title
Difference in the serum concentration of LDL-C between treatment group and control group
Description
Chemistry evaluations
Time Frame
22 weeks
Title
Difference in the serum concentration of uric acid between treatment group and control group
Description
Chemistry evaluations
Time Frame
22 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fan Fan Hou, M.D.,PhD
Phone
0086-20-61641591
Email
ffhouguangzhou@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fan Fan Hou, M.D.,PhD
Organizational Affiliation
Division of nephrology, Nanfang Hospital Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renal Division, Nanfang Hospital,Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fan Fan Hou, M.D., Ph.D.
Phone
86-20-61641597
Email
ffhou@public.guangzhou.gd.cn
First Name & Middle Initial & Last Name & Degree
Fan Fan Hou, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Sheng Nie, M.D.
12. IPD Sharing Statement
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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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