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

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ClinicalTrials.gov Identifier: NCT02299310
Recruitment Status : Unknown
Verified November 2014 by Ri-Bao Wei, Chinese PLA General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 24, 2014
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Ri-Bao Wei, 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Valsartan Drug: Perindopril Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Valsartan vs Perindopril on HOMA-IR Index in Patients With Chronic Kidney Disease
Study Start Date : November 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Valsartan
Valsartan 80mg/tablet, 1 tablet once daily (crossover)
Drug: Valsartan
Valsartan 80mg/tablet, 1 tablet once daily (crossover)
Other Name: NOVARTIS

Active Comparator: Perindopril
Perindopril 4mg/tablet, 1 tablet once daily (crossover)
Drug: Perindopril
Perindopril 4mg/tablet, 1 tablet once daily (crossover)
Other Name: ACERTIL




Primary Outcome Measures :
  1. Homeostasis model of assessment for insulin resistence index (HOMA-IR index) [ Time Frame: 4 weeks ]
    HOMA-IR=FINS*FGLU/22.5


Secondary Outcome Measures :
  1. Glomerular filtration rate(eGFR) and Creatinine clearance rate(CCR) [ Time Frame: 4 weeks ]
    eGFR and CCR are calculated with MDRD formula

  2. Body mass index(BMI) [ Time Frame: 4 weeks ]
    BMI=weight/(height)^2

  3. 24-h urine protein, urinary albumin-creatinin ration, retinol binding protein [ Time Frame: 4 weeks ]
  4. Cholesterol, triglycerides, high density lipoprotein, low density lipoprotein [ Time Frame: 4 weeks ]
  5. Glycosylated hemoglobin [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299310


Contacts
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Contact: RiBao Wei, Master +861055499133 wrbbj2006@126.com
Contact: Rui Wang, Master +861055499133 wrbbj2014@126.com

Locations
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China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Study Chair: RiBao Wei, Master Department of Nephrology, Chinese PLA General Hospital

Publications:
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Responsible Party: Ri-Bao Wei, Nephrology, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02299310     History of Changes
Other Study ID Numbers: S2014-088
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Ri-Bao Wei, Chinese PLA General Hospital:
Chronic kidney disease, Anti-hypertensive drugs

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Valsartan
Perindopril
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors