UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter randomized study evaluating the efficacy and safety of HMG-CoA reductase inhibitors (statins) in dyslipidemic patients with nephrosclerosis.
Acronym	Prospective evaluation of eGFR in CKD with nephrosclerosis by lipid intervention study (LAKE study)
Scientific Title	A multicenter randomized study evaluating the efficacy and safety of HMG-CoA reductase inhibitors (statins) in dyslipidemic patients with nephrosclerosis.
Scientific Title:Acronym	Prospective evaluation of eGFR in CKD with nephrosclerosis by lipid intervention study (LAKE study)
Region	Japan

Condition
Condition	Nephrosclerosis
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the effect of statins on dyslipidemic patients with nephrosclerosis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	An absolute change of estimated glomerular filtration rate
Key secondary outcomes	1. An absolute change of renal function -urinary albumin or protein, serum creatinine, urinary beta 2 microglobulin(BMG), urinary N-acetyl-beta-D-glucosaminidase(NAG) 2. An absolute change of serum lipids -TC, LDL-C, TG, HDL-C, non HDL-C, apolipoprotein(Apo A-I, Apo A-II, ApoB)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pitavastatin group
Interventions/Control_2	Control group
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. Nephrosclerotic patients whose serum LDL-C levels are lower than the levels of management goals recommended by guidline 2. eGFR<60mL/min/1.73m2 3. Proteinuria<0.5g/day(or <0.5g/gCr) 4. HbA1c<6.5%(NGSP) 5. Patients 20 years or older at the time of provision of consent 6. Patients who are treated with anti-hypertensive drugs
Key exclusion criteria	1. Patients who are treated with statins 2. Patients who are planned to start or change medication for renal disease 3. Severe hypertensive patients (SBP>=150mmHg or DBP >=90mmHg) 4. Severe hepatic dysfunction 5. Abnormal values of serum creatinine caused by any disease except renal disease 6. BMI>25(kg/m2) 7. Patients with thyroid dysfunction 8. History of acute myocardial infarction or stroke during three months prior to the registration 9. Pregnant, breast feeding, or could be pregnant 10. Patients who do not accept informed consent 11. Patients judged as being inappropriate for this study by investigators
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Tsuguru Middle name Last name Hatta
Organization	Omihachiman Community Medical Center
Division name	Division of Nephrology
Zip code	523-0082
Address	1379, Tsuchida-cho, Omihachiman- shi, Siga 523-0082, Japan
TEL	0748-33-3151
Email	tsuguhatta@hotmail.com

Public contact
Name of contact person	1st name Tsuguru Middle name Last name Hatta
Organization	Omihachiman Community Medical Center
Division name	Division of Nephrology
Zip code	523-0082
Address	1379, Tsuchida-cho, Omihachiman- shi, Siga 523-0082, Japan
TEL	0748-33-3151
Homepage URL
Email	tsuguhatta@hotmail.com

Sponsor
Institute	Omihachiman Community Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nagahama City Hospital Nagahama red cross Hospital Kotou Memorial Hospital Hashimoto Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Omihachiman Community Medical Center
Address	1379, Tsuchida-cho, Omihachiman- shi, Siga 523-0082, Japan
Tel	0748-33-3151
Email	030202@city.omihachiman.lg.jp

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	市立長浜病院（滋賀県） 長浜赤十字病院（滋賀県） 湖東記念病院（滋賀県） 橋本医院（滋賀県）

Other administrative information
Date of disclosure of the study information	2012 Year 01 Month 24 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	77
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	No longer recruiting
Date of protocol fixation	2011 Year 05 Month 30 Day
Date of IRB	2011 Year 06 Month 01 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 01 Month 24 Day
Last modified on	2021 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008396