A Prospective, Single-center, Randomized, Controlled Study of Sevelamer Carbonate in the Lipid Metabolism and Uric Acid Treatment of Obesity-Related Glomerulopathy
Not Applicable
Terminated
- Conditions
- Obesity and Glomerulopathy
- Interventions
- Drug: Low dosage Sevelamer Carbonate + IrbesartanDrug: High dosage Sevelamer Carbonate + Irbesartan
- Registration Number
- NCT02644486
- Lead Sponsor
- Zhi-Hong Liu, M.D.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C Group Irbesartan - B Group Low dosage Sevelamer Carbonate + Irbesartan - A Group High dosage Sevelamer Carbonate + Irbesartan -
- Primary Outcome Measures
Name Time Method low-density lipoprotein 12 weeks decreased levels of low-density lipoprotein from baseline
- Secondary Outcome Measures
Name Time Method uric acid 12 weeks Changes of uric acid from baseline after 12 weeks of treatment
blood glucose 12 weeks Changes of blood glucose from baseline after 12 weeks of treatment
blood lipids parameters (CHO, TG, HDL) 12 weeks Changes of blood lipids parameters from baseline after 12 weeks of treatment
proteinuria 12 weeks Changes of proteinuria from baseline after 12 weeks of treatment
glycated hemoglobin 12 weeks Changes of glycated hemoglobin from baseline after 12 weeks of treatment
Trial Locations
- Locations (1)
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
🇨🇳Nanjing, Jiangsu, China