Study Stopped
difficulty in enrollment
A Prospective, Single-center, Randomized, Controlled Study of Sevelamer Carbonate in the Lipid Metabolism and Uric Acid Treatment of Obesity-Related Glomerulopathy
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2015
CompletedFirst Posted
Study publicly available on registry
December 31, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedOctober 2, 2018
September 1, 2018
2.1 years
December 30, 2015
September 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
low-density lipoprotein
decreased levels of low-density lipoprotein from baseline
12 weeks
Secondary Outcomes (5)
uric acid
12 weeks
blood lipids parameters (CHO, TG, HDL)
12 weeks
proteinuria
12 weeks
blood glucose
12 weeks
glycated hemoglobin
12 weeks
Study Arms (3)
A Group
EXPERIMENTALB Group
EXPERIMENTALC Group
ACTIVE COMPARATORInterventions
Sevelamer Carbonate 4.8g/d+Irbesartan 300mg/d
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, 210002, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
December 30, 2015
First Posted
December 31, 2015
Study Start
January 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
October 2, 2018
Record last verified: 2018-09