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

Phase 4

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Valsartan; Drug: Perindopril

• Registration Number: NCT02299310
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

The purpose of this study is to compare the effect of valsartan and perindopril on HOMA-IR Index in patients with chronic kidney disease.

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 Timeline

• Status Verified: 2014-11
• Study Start: 2014-11
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Last Update Submitted: 2014-11-29
• Last Update Posted: 2014-12-02
• Primary Completion: 2015-11
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Valsartan	Valsartan	Valsartan 80mg/tablet, 1 tablet once daily (crossover)
Perindopril	Perindopril	Perindopril 4mg/tablet, 1 tablet once daily (crossover)

Primary Outcome Measures

Name	Time	Method
Homeostasis model of assessment for insulin resistence index (HOMA-IR index)	4 weeks	HOMA-IR=FINS\*FGLU/22.5

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China