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

Zhi-Hong Liu, M.D.

Status: Terminated

Conditions: Obesity and Glomerulopathy

Treatments: Drug: Low dosage Sevelamer Carbonate + Irbesartan; Drug: Irbesartan; Drug: High dosage Sevelamer Carbonate + Irbesartan

Study type: Interventional

Funder types: Other

Identifiers

NCT02644486

NJCT-1406

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 3 patient groups

A Group

Experimental group

Treatment:

Drug: High dosage Sevelamer Carbonate + Irbesartan

B Group

Experimental group

Treatment:

Drug: Low dosage Sevelamer Carbonate + Irbesartan

C Group

Active Comparator group

Treatment:

Drug: Irbesartan