NCT02299310

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

November 20, 2014

Last Update Submit

November 29, 2014

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney disease, Anti-hypertensive drugs

Outcome Measures

Primary Outcomes (1)

  • Homeostasis model of assessment for insulin resistence index (HOMA-IR index)

    HOMA-IR=FINS\*FGLU/22.5

    4 weeks

Secondary Outcomes (5)

  • Glomerular filtration rate(eGFR) and Creatinine clearance rate(CCR)

    4 weeks

  • Body mass index(BMI)

    4 weeks

  • 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

Study Arms (2)

Valsartan

EXPERIMENTAL

Valsartan 80mg/tablet, 1 tablet once daily (crossover)

Drug: Valsartan

Perindopril

ACTIVE COMPARATOR

Perindopril 4mg/tablet, 1 tablet once daily (crossover)

Drug: Perindopril

Interventions

ValsartanDRUG

Valsartan 80mg/tablet, 1 tablet once daily (crossover)

Also known as: NOVARTIS
Valsartan
PerindoprilDRUG

Perindopril 4mg/tablet, 1 tablet once daily (crossover)

Also known as: ACERTIL
Perindopril

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (3)

  • Satirapoj B, Leelasiri K, Supasyndh O, Choovichian P. Short-term administration of an angiotensin II receptor blocker in patients with long-term hemodialysis patients improves insulin resistance. J Med Assoc Thai. 2014 Jun;97(6):574-81.

    PMID: 25137874BACKGROUND

  • Ushijima K, Takuma M, Ando H, Ishikawa-Kobayashi E, Nozawa M, Maekawa T, Shiga T, Fujimura A. Effects of telmisartan and valsartan on insulin sensitivity in obese diabetic mice. Eur J Pharmacol. 2013 Jan 5;698(1-3):505-10. doi: 10.1016/j.ejphar.2012.11.022. Epub 2012 Nov 27.

    PMID: 23195328BACKGROUND

  • Iwashita M, Sakoda H, Kushiyama A, Fujishiro M, Ohno H, Nakatsu Y, Fukushima T, Kumamoto S, Tsuchiya Y, Kikuchi T, Kurihara H, Akazawa H, Komuro I, Kamata H, Nishimura F, Asano T. Valsartan, independently of AT1 receptor or PPARgamma, suppresses LPS-induced macrophage activation and improves insulin resistance in cocultured adipocytes. Am J Physiol Endocrinol Metab. 2012 Feb 1;302(3):E286-96. doi: 10.1152/ajpendo.00324.2011. Epub 2011 Nov 1.

    PMID: 22045314BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

ValsartanlactitolPerindopril

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • RiBao Wei, Master

    Department of Nephrology, Chinese PLA General Hospital

    STUDY CHAIR

Central Study Contacts

RiBao Wei, Master

CONTACT

+861055499133wrbbj2006@126.com

Rui Wang, Master

CONTACT

+861055499133wrbbj2014@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nephrology

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 24, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

CN(1)