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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02644486

Enrollment

Registered

2015-12-31

Start date

2016-01-31

Completion date

2018-02-28

Last updated

2018-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity and Glomerulopathy

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.

Interventions

DRUGHigh dosage Sevelamer Carbonate + Irbesartan

Sevelamer Carbonate 4.8g/d+Irbesartan 300mg/d

DRUGLow dosage Sevelamer Carbonate + Irbesartan

Sevelamer Carbonate 2.4g/d+Irbesartan 300mg/d

DRUGIrbesartan

Irbesartan 300mg/d

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
low-density lipoprotein	12 weeks	decreased levels of low-density lipoprotein from baseline

Secondary

Measure	Time frame	Description
uric acid	12 weeks	Changes of uric acid 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
blood glucose	12 weeks	Changes of blood glucose from baseline after 12 weeks of treatment
glycated hemoglobin	12 weeks	Changes of glycated hemoglobin from baseline after 12 weeks of treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026