- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02644486
A Prospective, Single-center, Randomized, Controlled Study of Sevelamer Carbonate in the Lipid Metabolism and Uric Acid Treatment of Obesity-Related Glomerulopathy
September 29, 2018 updated by: Zhi-Hong Liu, M.D.
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.
Study Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210002
- Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
-
-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: A Group
|
Sevelamer Carbonate 4.8g/d+Irbesartan 300mg/d
|
Experimental: B Group
|
Sevelamer Carbonate 2.4g/d+Irbesartan 300mg/d
|
Active Comparator: C Group
|
Irbesartan 300mg/d
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
low-density lipoprotein
Time Frame: 12 weeks
|
decreased levels of low-density lipoprotein from baseline
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
uric acid
Time Frame: 12 weeks
|
Changes of uric acid from baseline after 12 weeks of treatment
|
12 weeks
|
blood lipids parameters (CHO, TG, HDL)
Time Frame: 12 weeks
|
Changes of blood lipids parameters from baseline after 12 weeks of treatment
|
12 weeks
|
proteinuria
Time Frame: 12 weeks
|
Changes of proteinuria from baseline after 12 weeks of treatment
|
12 weeks
|
blood glucose
Time Frame: 12 weeks
|
Changes of blood glucose from baseline after 12 weeks of treatment
|
12 weeks
|
glycated hemoglobin
Time Frame: 12 weeks
|
Changes of glycated hemoglobin from baseline after 12 weeks of treatment
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
January 1, 2016
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
February 1, 2018
Study Registration Dates
First Submitted
December 30, 2015
First Submitted That Met QC Criteria
December 30, 2015
First Posted (Estimate)
December 31, 2015
Study Record Updates
Last Update Posted (Actual)
October 2, 2018
Last Update Submitted That Met QC Criteria
September 29, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NJCT-1406
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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