UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005564 |
|---|---|
| Receipt number | R000005552 |
| Scientific Title | The efficacy of Carperitide 3-days continuous intravenous injection for the subjects with RAS-inhibitors resistant diabetic nephropathy |
| Date of disclosure of the study information | 2011/05/06 |
| Last modified on | 2020/05/21 14:42:52 |
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Basic information
Public title
The efficacy of Carperitide 3-days continuous intravenous injection for the subjects with RAS-inhibitors resistant diabetic nephropathy
Acronym
Carperitide iv for RASI resistant diabetic nephropathy
Scientific Title
The efficacy of Carperitide 3-days continuous intravenous injection for the subjects with RAS-inhibitors resistant diabetic nephropathy
Scientific Title:Acronym
Carperitide iv for RASI resistant diabetic nephropathy
Region
| Japan |
Condition
Condition
diabetic nephropathy
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the renal function preservative effects of Carperitide 3-days continuous intravenous injection for the subjects with RAS-inhibitors resistant diabetic nephropathy by clinical parameters
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
change of renal functions related parameters including Cr, BUN, cystatin C, urinary protein excretion and urinary albumin excretion
Key secondary outcomes
change of the markers reflecting lipoprotein metabolism; T-cho, TG, LDL-C, sdLDL=small dense LDL, pre-beta1-HDL
change of blood pressure
change of Renin-angiotensin-aldosterone system related parameters; Plasma renin activity, aldosterone concentration
change of oxidative stress related markers; urinary 8-OHdG excretion, urinary isoprostane
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
continuous infusion of 0.01 to 0.02 micro gram/body weight (kg)/min of Carperitide for three days
Interventions/Control_2
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
study subjects should meet the criteria below; serum creatine greater than 1.7mg/dl to less than 4.0mg/dl, and urinary protein amount greater than 1 gram per 1 gram of urinary creatinine.
Key exclusion criteria
exclusion criteria are shown as below; subjects with decreased hepatic metabolism including acute hepatitis, exaggerated phase of chronic hepatitis, liver cirrhosis, hepatocellular carcinoma and jaundice, women with pregnancy and its possibility or lactation and subjects whom the attending doctor considered as non-suitable for the entry for this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kunimasa |
| Middle name | |
| Last name | Yagi |
Organization
Kanazawa University Hospital
Division name
department of endocrinology and metabolism
Zip code
920-8164
Address
13-1 Takaramachi, Kanazawa
TEL
076-265-2000
diabe@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kunimasa |
| Middle name | |
| Last name | Yagi |
Organization
Kanazawa University Hospital
Division name
department of endocrinology and metabolism
Zip code
920-8164
Address
13-1 Takaramachi, Kanazawa
TEL
076-265-2000
Homepage URL
diabe@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University, Graduate School of Internal Medicine, department of internal medicine
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University, Graduate School of Internal Medicine, department of internal medicine
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
Kanazawa University Hospital
Address
13-1 Takaramachi, Kanazawa
Tel
076-265-2000
diabe@med,kanazawa-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
| 2011 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
http://intmed2.w3.kanazawa-u.ac.jp
Publication of results
Unpublished
Result
URL related to results and publications
http://intmed2.w3.kanazawa-u.ac.jp
Number of participants that the trial has enrolled
2
Results
Canceled due to the insufficient numbers of the cases
Results date posted
| 2020 | Year | 05 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
diabetic nephropathy
Participant flow
Div during admission
Adverse events
nothing
Outcome measures
Difficult to evaluate due to insufficient number of the cases
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2010 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2010 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 06 | Day |
Last modified on
| 2020 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005552
