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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002887
Receipt No. R000003523
Scientific Title A multicenter study to examine renal protection by a combination of an HMG-CoA reductase inhibitor and losartan in patients with dyslipidemia associated with IgA nephropathy
Date of disclosure of the study information 2009/12/14
Last modified on 2017/12/20

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Basic information
Public title A multicenter study to examine renal protection by a combination of an HMG-CoA reductase inhibitor and losartan in patients with dyslipidemia associated with IgA nephropathy
Acronym LIPS study
Scientific Title A multicenter study to examine renal protection by a combination of an HMG-CoA reductase inhibitor and losartan in patients with dyslipidemia associated with IgA nephropathy
Scientific Title:Acronym LIPS study
Region
Japan

Condition
Condition IgA nephropathy
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study will examine inhibition of the progression of renal dysfunction in patients with dyslipidemia associated with IgA nephropathy in a group administered a combination of losartan and a statin and a group administered a statin alone.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The effectiveness of reducing proteinuria in spot urine samples will be compared in a control group receiving statin therapy alone for 2 years and a treatment group given statin therapy and losartan.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 statin and losartan group:
simvastatin 5mg and Losartan 50mg/day more than 3 months
Interventions/Control_2 statin group:
simvastatin 5mg/day more than 3 months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Men and women over the age of 20
2.Patients with dislipidemia(LDL cholesterol: 120 mg/dL or higher)
3.Patients who need a therapy of hypertention (JSH2009)
4.Patients not taking an ACE inhibitor or ARB within the last 3 months
5.Patients who have provided written consent
Key exclusion criteria 1.Patients with type 1 diabetes mellitus
2.Patients with cardiovascular disease and with the following conditions
Patients who have undergone coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the last 3 months, patients with unstable angina, patients with a history of myocardial infarction, patients with a history of a transient ischemic attack (TIA) within the last 6 months, patients that are NYHA functional class III or IV or with heart failure, and patients with a history of cerebral infarction within the last 3 months
3. serum Cr>2.5mg/dL or eGFR<30mL/min
4.Patients with severe liver dysfunction
5.Patients with secondary hypertension caused by factors other than diabetes mellitus
6.HbA1c > 9%
7.Patients with pregnancy or nursing
8.Other patients deemed ineligible by an investigator
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Saito
Organization Fukuoka University Faculty of Medicine
Division name Division of Nephrology and Rheumatology, Department of Internal Medicine
Zip code
Address 7-45-1, Nanakuma, Jonan-ku, Fukuoka, Japan
TEL +81-92-801-1011
Email tsaito@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Ogahara
Organization Fukuoka University Faculty of Medicine
Division name Division of Nephrology and Rheumatology, Department of Internal Medicine
Zip code
Address 7-45-1, Nanakuma, Jonan-ku, Fukuoka, Japan
TEL +81-92-801-1011
Homepage URL
Email sogahara@cis.fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Faculty of Medicine
Institute
Department

Funding Source
Organization The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2009 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 14 Day
Last modified on
2017 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003523

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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