Effect of Valsartan vs Perindopril on HOMA-IR Index in Patients With Chronic Kidney Disease

November 29, 2014 updated by: Ri-Bao Wei, Chinese PLA General Hospital
The purpose of this study is to compare the effect of valsartan and perindopril on HOMA-IR Index in patients with chronic kidney disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

eligiable volunteers are administrated single-dose over the period I and II (crossover) of Valsartan (80mg) as of Perindopril (4mg).

Every time before and after each medication, HOMA-IR index and other parameters and safety of Valsartan (80mg) and Perindopril (4mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of chronic kidney disease
  • Serum creatinine:1~3mg/dl

Exclusion Criteria:

  • Diabetes
  • Patients treated with corticosteroids or immunosuppressants
  • BMI>30kg/m2
  • SP>180mmHg, DP>110mmHg
  • Patients with serious medical problems requiring specific medical treatment

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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Valsartan
Valsartan 80mg/tablet, 1 tablet once daily (crossover)
Drug: Valsartan
Valsartan 80mg/tablet, 1 tablet once daily (crossover)
Other Names:
  • NOVARTIS
Active Comparator: Perindopril
Perindopril 4mg/tablet, 1 tablet once daily (crossover)
Drug: Perindopril
Perindopril 4mg/tablet, 1 tablet once daily (crossover)
Other Names:
  • ACERTIL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homeostasis model of assessment for insulin resistence index (HOMA-IR index)
Time Frame: 4 weeks
HOMA-IR=FINS*FGLU/22.5
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glomerular filtration rate(eGFR) and Creatinine clearance rate(CCR)
Time Frame: 4 weeks
eGFR and CCR are calculated with MDRD formula
4 weeks
Body mass index(BMI)
Time Frame: 4 weeks
BMI=weight/(height)^2
4 weeks
24-h urine protein, urinary albumin-creatinin ration, retinol binding protein
Time Frame: 4 weeks
4 weeks
Cholesterol, triglycerides, high density lipoprotein, low density lipoprotein
Time Frame: 4 weeks
4 weeks
Glycosylated hemoglobin
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Chinese PLA General Hospital

Investigators

  • Study Chair: RiBao Wei, Master, Department of Nephrology, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2014

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 29, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2014-088

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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