UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005564
Receipt No. 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 (Ver. 7)

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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
Email 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
Email diabe@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University, Graduate School of Internal Medicine, department of internal medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005552