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Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000002887
Date of registration:	14/12/2009
Prospective Registration:	No
Primary sponsor:	Fukuoka University Faculty of Medicine
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
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 - LIPS study
Date of first enrolment:	2009/12/01
Target sample size:	80
Recruitment status:	Recruiting
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003523
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Takao Saito
Address:	7-45-1, Nanakuma, Jonan-ku, Fukuoka, Japan
Telephone:	+81-92-801-1011
Email:	tsaito@fukuoka-u.ac.jp
Affiliation:	Fukuoka University Faculty of Medicine Division of Nephrology and Rheumatology, Department of Internal Medicine

Name:	Satoru Ogahara
Address:	7-45-1, Nanakuma, Jonan-ku, Fukuoka, Japan
Telephone:	+81-92-801-1011
Email:	sogahara@cis.fukuoka-u.ac.jp
Affiliation:	Fukuoka University Faculty of Medicine Division of Nephrology and Rheumatology, Department of Internal Medicine

Key inclusion & exclusion criteria

Inclusion criteria:
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

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

IgA nephropathy

Intervention(s)

statin and losartan group: simvastatin 5mg and Losartan 50mg/day more than 3 months
statin group: simvastatin 5mg/day more than 3 months

Primary Outcome(s)

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.

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

The Kidney Foundation, Japan

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	01/03/2012
URL:

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