Back to resultsA Prospective, Single-center, Randomized, Controlled Study of Sevelamer Carbonate in the Lipid Metabolism and Uric Acid Treatment of Obesity-Related Glomerulopathy
Primary Purpose
Obesity and Glomerulopathy
Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High dosage Sevelamer Carbonate + Irbesartan
Low dosage Sevelamer Carbonate + Irbesartan
Irbesartan
Sponsored by
About this trial
This is an interventional treatment trial for Obesity and Glomerulopathy
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of obesity
- diagnosed ORG by renal biopsy
- LDL>3.37mmol/L
- Proteinuria 0.5-3.5g/d
- eGFR (CKD-EPI formula) > 30ml/min
Exclusion Criteria:
- Other concomitant renal diseases
- Endocrine or drug-induced obesity;
- Type 2 diabetes
- eyes or obvious microscopic hematuria;
- Swallowing difficulty / severe gastrointestinal dysfunction
- intestinal obstruction;
- severe arrhythmia;
- Hypophosphatemia (<0.7mmol/L);
- allergic to Sevelamer Carbonate
- unable to well cooperate
- Females who are in the period of gestation or lactation, or refuse to use contraception;
- participated in other clinical trial of drug within three months
Sites / Locations
- Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
A Group
B Group
C Group
Arm Description
Outcomes
Primary Outcome Measures
low-density lipoprotein
decreased levels of low-density lipoprotein from baseline
Secondary Outcome Measures
uric acid
Changes of uric acid from baseline after 12 weeks of treatment
blood lipids parameters (CHO, TG, HDL)
Changes of blood lipids parameters from baseline after 12 weeks of treatment
proteinuria
Changes of proteinuria from baseline after 12 weeks of treatment
blood glucose
Changes of blood glucose from baseline after 12 weeks of treatment
glycated hemoglobin
Changes of glycated hemoglobin from baseline after 12 weeks of treatment
Full Information
NCT ID
NCT02644486
First Posted
December 30, 2015
Last Updated
September 29, 2018
Sponsor
Zhi-Hong Liu, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT02644486
Brief Title
A Prospective, Single-center, Randomized, Controlled Study of Sevelamer Carbonate in the Lipid Metabolism and Uric Acid Treatment of Obesity-Related Glomerulopathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
difficulty in enrollment
Study Start Date
January 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhi-Hong Liu, M.D.
4. Oversight
5. Study Description
Brief Summary
To observe the decreased levels of low-density lipoprotein from baseline in patients with obesity-related glomerulopathy (ORG) after 12 weeks of Sevelamer Carbonate treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity and Glomerulopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A Group
Arm Type
Experimental
Arm Title
B Group
Arm Type
Experimental
Arm Title
C Group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
High dosage Sevelamer Carbonate + Irbesartan
Intervention Description
Sevelamer Carbonate 4.8g/d+Irbesartan 300mg/d
Intervention Type
Drug
Intervention Name(s)
Low dosage Sevelamer Carbonate + Irbesartan
Intervention Description
Sevelamer Carbonate 2.4g/d+Irbesartan 300mg/d
Intervention Type
Drug
Intervention Name(s)
Irbesartan
Intervention Description
Irbesartan 300mg/d
Primary Outcome Measure Information:
Title
low-density lipoprotein
Description
decreased levels of low-density lipoprotein from baseline
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
uric acid
Description
Changes of uric acid from baseline after 12 weeks of treatment
Time Frame
12 weeks
Title
blood lipids parameters (CHO, TG, HDL)
Description
Changes of blood lipids parameters from baseline after 12 weeks of treatment
Time Frame
12 weeks
Title
proteinuria
Description
Changes of proteinuria from baseline after 12 weeks of treatment
Time Frame
12 weeks
Title
blood glucose
Description
Changes of blood glucose from baseline after 12 weeks of treatment
Time Frame
12 weeks
Title
glycated hemoglobin
Description
Changes of glycated hemoglobin from baseline after 12 weeks of treatment
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of obesity
diagnosed ORG by renal biopsy
LDL>3.37mmol/L
Proteinuria 0.5-3.5g/d
eGFR (CKD-EPI formula) > 30ml/min
Exclusion Criteria:
Other concomitant renal diseases
Endocrine or drug-induced obesity;
Type 2 diabetes
eyes or obvious microscopic hematuria;
Swallowing difficulty / severe gastrointestinal dysfunction
intestinal obstruction;
severe arrhythmia;
Hypophosphatemia (<0.7mmol/L);
allergic to Sevelamer Carbonate
unable to well cooperate
Females who are in the period of gestation or lactation, or refuse to use contraception;
participated in other clinical trial of drug within three months
Facility Information:
Facility Name
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Prospective, Single-center, Randomized, Controlled Study of Sevelamer Carbonate in the Lipid Metabolism and Uric Acid Treatment of Obesity-Related Glomerulopathy
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