UMIN-CTR Clinical Trial

Public title

Additive effect of Lipid-Lowering by atrovaSTatin on Amelioration of Renal hemodynamic in patients with CKD

Acronym

Additive effect of Lipid-Lowering by atrovaSTatin on Amelioration of Renal hemodynamic in patients with CKD(ALL-STAR-CKD)

Scientific Title

Additive effect of Lipid-Lowering by atrovaSTatin on Amelioration of Renal hemodynamic in patients with CKD

Scientific Title:Acronym

Additive effect of Lipid-Lowering by atrovaSTatin on Amelioration of Renal hemodynamic in patients with CKD(ALL-STAR-CKD)

Region

Japan

Condition

Chronic Kidney Disease(CKD)

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Clarify Atolbastatin increases glomerular filtration rate(GFR) and renal plasma flow (RPF), and contribute to development the chronic kidney disease (CKD) patient's new treatment method development.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Primary outcomes

Amount of change and change rate ofinulin clearance and para amino hippuric acid clearance.

Key secondary outcomes

1.Filtration fraction (FF)filtration rate
2.Renal Vascular Resistance(RVR)
3.Serum creatinine
4.serum cystatin C
5.eGFR (Estimated glomerular filtration rate of Japanese calculated using creatinine and cystatin C ).
6.Creatinine production rate.
7.Liver-Type Fatty Acid Binding Protein(L-FABP).
8.proteinuria(g/gCr) and albuminuria(mg/gCr)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Atrovastatin (10mg/day) is added in patients with medical diet.

Interventions/Control_2

Ezetimibe (10mg/day) is added in patients with medical diet. in case of insufficient effect,treatment with non-Statin medicine such as cholestyramines.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1)CKD patient who amalgamates GFR30-90 mL/min/1.73m2 and hypercholesterolemia.If hypercholesterolemia amalgamate the diabetic,LDL cholesterol is over 120mg/dL .If hypercholesterolemia isn't amalgamate the diabetic,LDL cholesterol is abobe 140mg/dL . The LDL cholesterol is excluded from the object for 180mg/dL or more regardless of the
presence of the diabetic amalgamation.
2)Statin will not be taken in the past six months.
3)From 20 to less than 75 years old

Key exclusion criteria

1)Defective diabetic for control(abobe FBS160mg/dL,HbA1c8%)
2)Familial hypercholesteremia.
3)The past of event of cardiovascular disease.
4)High blood pressure that cannot be controlled(above 140mg/dL)
5)Patient who has previous history of hypersensitivity for Atolbastatin or Ezetimibe
6)Woman who has pregnant woman or possibility of pregnancy
7)Patient who judged that it is improper that physician in charge
puts it in to examination

Target sample size

120

Name of lead principal investigator

1st name
Middle name
Last name	Shoichi Maruyama

Organization

University of Nagoya Graduate School of Medicine

Division name

Nephrology

Zip code

Address

65 Tsurumai-cho, Showa-ku, Nagoya,Aichi,Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

University of Nagoya Graduate School of Medicine

Division name

Nephrology

Zip code

Address

65 Tsurumai-cho, Showa-ku, Nagoya,Aichi,Japan

TEL

Homepage URL

Email

Institute

Departmrnt of CKD initiatives,Nagoya university graduate school of medicine

Institute

Department

Personal name

Organization

Department of Nephrology,Nagoya university graduate school of medicine

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

11

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2011

Year

11

Month

16

Day

Date of IRB

Anticipated trial start date

2011

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

11

Month

03

Day

Last modified on

2012

Year

04

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007873