UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002887 |
|---|---|
| Receipt number | 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 09:53:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
sogahara@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
