A Prospective, Single-center, Randomized, Controlled Study of Sevelamer Carbonate in the Lipid Metabolism and Uric Acid Treatment of Obesity-Related Glomerulopathy

Obesity and Glomerulopathy Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02644486
• Other study ID #: NJCT-1406
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: February 2018

Study information

• Verified date: September 2018
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity and Glomerulopathy

Intervention

Drug:
• High dosage Sevelamer Carbonate + Irbesartan
Sevelamer Carbonate 4.8g/d+Irbesartan 300mg/d
• Low dosage Sevelamer Carbonate + Irbesartan
Sevelamer Carbonate 2.4g/d+Irbesartan 300mg/d
• Irbesartan
Irbesartan 300mg/d

Locations

Country	Name	City	State
China	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhi-Hong Liu, M.D.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	low-density lipoprotein	decreased levels of low-density lipoprotein from baseline	12 weeks
Secondary	uric acid	Changes of uric acid from baseline after 12 weeks of treatment	12 weeks
Secondary	blood lipids parameters (CHO, TG, HDL)	Changes of blood lipids parameters from baseline after 12 weeks of treatment	12 weeks
Secondary	proteinuria	Changes of proteinuria from baseline after 12 weeks of treatment	12 weeks
Secondary	blood glucose	Changes of blood glucose from baseline after 12 weeks of treatment	12 weeks
Secondary	glycated hemoglobin	Changes of glycated hemoglobin from baseline after 12 weeks of treatment	12 weeks