UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005392 |
|---|---|
| Receipt number | R000006399 |
| Scientific Title | Effects of aggressive lipid-lowering therapy in patients with glomerulonephritis |
| Date of disclosure of the study information | 2011/04/11 |
| Last modified on | 2021/08/05 18:22:27 |
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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
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
kentaro-kyu@umin.org
Sponsor or person
Institute
Division of Nephrology & Kidney Center, Kobe University School of Medicine.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006399
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