UMIN-CTR Clinical Trial

Basic information
Public title	Effects of aggressive lipid-lowering therapy in patients with glomerulonephritis
Acronym	Statin therapy for glomerulonephritis
Scientific Title	Effects of aggressive lipid-lowering therapy in patients with glomerulonephritis
Scientific Title:Acronym	Statin therapy for glomerulonephritis
Region	Japan

Condition
Condition	glomerulonephritis
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficiency of early statin therapy against urinary protein, renal function and the damage of vascular endothelial cells in patients with glomerulonephritis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in urinary protein Changes in eGFR Changes in ADMA and endothelial lipase
Key secondary outcomes	Serum lipid profile (Total cholesterol,LDL cholesterol, triglyceride) , apolipoprotein, and high-sensitive CRP

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of statins
Interventions/Control_2	No administration of statins
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) Patients with glomerulonephritis 2) Patients with lipid disorder (LDL-C of 100 mg/dl or more)
Key exclusion criteria	1) Allergy against statins 2) Pregnant 3) Patients judged as being inappropriate for this study by investigators
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shinichi Middle name Last name Nishi
Organization	Kobe University School of Medicine
Division name	Division of Nephrology & Kidney Center
Zip code	650-0017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
TEL	078-382-6500
Email	snishi@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Nakai
Organization	Kobe University School of Medicine
Division name	Division of Nephrology & Kidney Center
Zip code	650-0017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
TEL	078-382-6500
Homepage URL
Email	kentaro-kyu@umin.org

Sponsor
Institute	Division of Nephrology & Kidney Center, Kobe University School of Medicine.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University School of Medicine
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
Tel	078-382-5045
Email	rinri@med.kobe-u.ac.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	神戸大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 11 Day

Related information
URL releasing protocol	https://endai.umin.ac.jp/cgi-open-bin/ojac/search/ojac_search.cgi?cond=%27A00018-00058-20324%27&&&pa
Publication of results	Unpublished

Result
URL related to results and publications	https://endai.umin.ac.jp/cgi-open-bin/ojac/search/ojac_search.cgi?cond=%27A00018-00058-20324%27&&&pa
Number of participants that the trial has enrolled	21
Results	At the time of remission of urinary protein, both groups showed a trend toward improvement in lipid abnormalities, but EL, which was not significantly different at the time of initiation of steroid therapy, remained higher in group A than in group C from the time of remission until 1 month later. After 3 months of remission, EL was similar in the two groups, but tended to be higher than at the beginning of treatment in both groups.
Results date posted	2021 Year 08 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Twenty-one consecutive patients with clinically determined MCNS who gave consent were randomized to receive atorvastatin (group A) or control (group C) for comparison.
Participant flow	Fifteen patients were diagnosed by renal biopsy as MCNS, one as membranous nephropathy, and four did not undergo renal biopsy. Twelve patients (60%) were male, and the median age was 42 years.
Adverse events	None
Outcome measures	At the time of remission of urinary protein, both groups showed a trend toward improvement in lipid abnormalities, but EL, which was not significantly different at the time of initiation of steroid therapy, remained higher in group A than in group C from the time of remission until 1 month later. After 3 months of remission, EL was similar in the two groups, but tended to be higher than at the beginning of treatment in both groups.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 04 Month 06 Day
Date of IRB	2011 Year 04 Month 06 Day
Anticipated trial start date	2011 Year 09 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2011 Year 04 Month 06 Day
Last modified on	2021 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006399