UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042284 |
|---|---|
| Receipt number | R000048278 |
| Scientific Title | Open label, randomized controlled trial of the selective PPAR-alpha modulator; Pemafibrate to the effect of urinary protein suppression in CKD patients with dyslipidemia |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2023/05/02 11:41:52 |
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Basic information
Public title
Open label, randomized controlled trial of Pemafibrate to evaluate renopotective effect in CKD patients
Acronym
Open label, randomized controlled trial of Pemafibrate to evaluate renopotective effect in CKD patients
Scientific Title
Open label, randomized controlled trial of the selective PPAR-alpha modulator; Pemafibrate to the effect of urinary protein suppression in CKD patients with dyslipidemia
Scientific Title:Acronym
Open label, randomized controlled trial of the selective PPAR-alpha modulator; Pemafibrate to the effect of urinary protein suppression in CKD patients with dyslipidemia
Region
| Japan |
Condition
Condition
chronic renal failure, dyslipidemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of pemafibrate on urinary protein suppression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of urinary protein amount at 12 months
Key secondary outcomes
Efficacy evaluation; change from baseline in follow items at 12 months after study start
(Lipid metabolism; Triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, very low-density lipoprotein, intermediate-density lipoprotein, small-dense low-density lipoprotein cholesterol, oxidant low-density lipoprotein cholesterol, apolipoproteinA1, apolipoproteinA2, apolipoproteinB, apolipoproteinB48, fibroblast growth factor 19, hepatic triglyceride lipase
Renal function; creatinine, estimated glomerular filtration rate, blood urea nitrogen, cystatin C
Urinary marker; albuminuria, liver-type fatty acid-binding protein, neutrophil gelatinase-associated lipocalin, kidney injury molecule-1, alpha1-microglobulin, beta2-microglobulin
Inflammation; high sensitive C-reactive protein, Interleukin-1beta, Interleukin-6, S100A8/A9
Liver function; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transpeptidase
Mineral and bone metabolism; calcium, phosphate, intact parathyroid hormone, alkaline phosphatase, bone-specific alkaline phosphatase, tartrate-resistant acid phosphatase 5b, osteoprotegerin, osteopontin, fetuinA, fibroblast growth factor 23, bone morphogenetic protein-2, bone morphogenetic protein-4, bone morphogenetic protein-7, bone morphogenetic protein-9)
Safety evaluation; Incidence of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
add on pemafibrate for 12 months
Interventions/Control_2
same treatment as before trial
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.Serum TG 150 mg/dL and over and under 1000 mg/dL at agreement.
2.UPCR 0.15 g/gCr and over for 3months at least.
3.Age 20 years and over
4.Outpatient of Kyushu university nephrologist for more than three months.
5.With written agreement
Key exclusion criteria
1.Using pemafibrate or some fibrates within 1 month before agreement.
2.Pregnant woman or woman being pregnancy during trial and lactating woman.
3.Allergy reaction to pemafibrate
4.Severe hepatic dysfunction or hepatic cirrhosis;Child-Pugh B or C or biliary obstruction.
5.Cholecystolithiasis
6.Serum Cr 2.5 mg/dL and over or CCr under 40 mL/min
revised in November 2022 as follows; Patients on dialysis therapy or expected to require renal replacement therapy during the study period
7.Severe nephrosis necessary much amount of immunosuppressive agents or steroid.
8.After kidney transplantation
9.Cardiovascular events within 3 months before agreement.
10.Using cyclosporin or rifampicin
11.Familial hypercholesterinemia or familial hypoalphalipoproteinemia
12.History of myositis or myopathy or elevation of serum CPK; over 5 times ULN
13.Active malignancy
14.Severe infection
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | toshiaki |
| Middle name | |
| Last name | nakano |
Organization
Kyushu University
Division name
Center for cohot studies
Zip code
812-8582
Address
3-1-1, maidashi, higashi-ku, fukuoka city, fukuoka prefecture, japan
TEL
092-642-5843
toshink@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | mai |
| Middle name | |
| Last name | seki |
Organization
Kyushu University
Division name
kidney care unit
Zip code
812-8582
Address
3-1-1, maidashi, higashi-ku, fukuoka city, fukuoka prefecture, japan
TEL
0926425843
Homepage URL
seki.mai.272@s.kyushu-u.ac.jp
Sponsor or person
Institute
kyushu university
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
kyushu university center for clinical and translational research
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN
Tel
0926425774
tr-info@med.kyushu-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 29 | Day |
Last modified on
| 2023 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048278
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
