UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007130 |
|---|---|
| Receipt number | R000008396 |
| Scientific Title | A multicenter randomized study evaluating the efficacy and safety of HMG-CoA reductase inhibitors (statins) in dyslipidemic patients with nephrosclerosis. |
| Date of disclosure of the study information | 2012/01/24 |
| Last modified on | 2021/02/01 18:26:09 |
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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
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
tsuguhatta@hotmail.com
Sponsor or person
Institute
Omihachiman Community Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008396
