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

September 29, 2018 updated by: Zhi-Hong Liu, M.D.
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A Group
Drug: High dosage Sevelamer Carbonate + Irbesartan
Sevelamer Carbonate 4.8g/d+Irbesartan 300mg/d
Experimental: B Group
Drug: Low dosage Sevelamer Carbonate + Irbesartan
Sevelamer Carbonate 2.4g/d+Irbesartan 300mg/d
Active Comparator: C Group
Drug: Irbesartan
Irbesartan 300mg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
low-density lipoprotein
Time Frame: 12 weeks
decreased levels of low-density lipoprotein from baseline
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
uric acid
Time Frame: 12 weeks
Changes of uric acid from baseline after 12 weeks of treatment
12 weeks
blood lipids parameters (CHO, TG, HDL)
Time Frame: 12 weeks
Changes of blood lipids parameters from baseline after 12 weeks of treatment
12 weeks
proteinuria
Time Frame: 12 weeks
Changes of proteinuria from baseline after 12 weeks of treatment
12 weeks
blood glucose
Time Frame: 12 weeks
Changes of blood glucose from baseline after 12 weeks of treatment
12 weeks
glycated hemoglobin
Time Frame: 12 weeks
Changes of glycated hemoglobin from baseline after 12 weeks of treatment
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhi-Hong Liu, M.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

December 30, 2015

First Submitted That Met QC Criteria

December 30, 2015

First Posted (Estimate)

December 31, 2015

Study Record Updates

Last Update Posted (Actual)

October 2, 2018

Last Update Submitted That Met QC Criteria

September 29, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJCT-1406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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