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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000581
Receipt No. R000000705
Scientific Title An Open-label Controlled Trial to Assess the Prophylactic Efficacy of N-Acetylcysteine on Radio-contrast Induced Nephropathy in Patients With Advanced Chronic Kidney Disease Planned to Start Dialysis Therapy
Date of disclosure of the study information 2007/02/01
Last modified on 2007/01/24

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Basic information
Public title An Open-label Controlled Trial to Assess the Prophylactic Efficacy of N-Acetylcysteine on Radio-contrast Induced Nephropathy in Patients With Advanced Chronic Kidney Disease Planned to Start Dialysis Therapy
Acronym Prophylactic Efficacy of N-Acetylcysteine(NAC) on Radio-contrast Induced Nephropathy(RCIN) in Patients With Advanced Chronic Kidney Disease(CKD) Planned to Start Dialysis Therapy
Scientific Title An Open-label Controlled Trial to Assess the Prophylactic Efficacy of N-Acetylcysteine on Radio-contrast Induced Nephropathy in Patients With Advanced Chronic Kidney Disease Planned to Start Dialysis Therapy
Scientific Title:Acronym Prophylactic Efficacy of N-Acetylcysteine(NAC) on Radio-contrast Induced Nephropathy(RCIN) in Patients With Advanced Chronic Kidney Disease(CKD) Planned to Start Dialysis Therapy
Region
Japan

Condition
Condition Patients with advanced CKD planned to dialysis therapy
Classification by specialty
Nephrology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to determine the prophylactic efficacy of N-acetylcysteine on radio-contrast induced nephropathy associated with coronary angiography or contrast-enhanced computed tomography in patients with advanced CKD planned to dialysis therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in creatinine clearance, serum creatinine and urine volume during two weeks after radio-contrast agent administration
Key secondary outcomes Change in residual renal function after induction of dialysis therapy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Oral administration of N-Acetylcysteine
Interventions/Control_2 Saline infusion at a rate of 1 ml/kg/hour for 12 hours before and after radiocontrast agent administration
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 Inpatients planned to start dialysis therapy and to be examined by coronary angiography or radiocontrast-enhanced computed tomography
Key exclusion criteria 1)Contraindicated to radiocontrast agent or N-Acetylcysteine
2)Malignancy
3)Congestive heart failure(NYHA III, IV)
4)Acute myocardial infarction, pulmonary embolism and cerebral infarction within 6 months
5)Diastolic blood pressure of 100 mmHg or more
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Terumasa Hayashi
Organization Rinku General Medical Center
Izumisano Municipal Hospital
Division name Department of Nephrology
Zip code
Address 2-23 Rinku-Orai Kita, Izumisano, Osaka
TEL 072-469-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Terumasa Hayashi
Organization Rinku General Medical Center, Izumisano Municipal Hospital
Division name Department of Nephrology
Zip code
Address 2-23 Rinku-Orai Kita, Izumisano, Osaka
TEL 072-469-3111
Homepage URL
Email t-hayashi@rgmc.izumisano.osaka.jp

Sponsor
Institute Department of Nephrology, Rinku General Medical Center Izumisano Municipal Hospital
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2007 Year 02 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
Date of protocol fixation
2006 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 01 Day
Last follow-up date
2009 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 01 Month 24 Day
Last modified on
2007 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000705

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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