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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005552


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name