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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001618
Receipt No. R000001946
Scientific Title An open label multi facilities cooperation randomized control trial to verify urinary angiotensinogen excretion reducing effect of olmesartan therapy in diabetic nephropathy.
Date of disclosure of the study information 2009/03/09
Last modified on 2015/06/08

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Basic information
Public title An open label multi facilities cooperation randomized control trial to verify urinary angiotensinogen excretion reducing effect of olmesartan therapy in diabetic nephropathy.
Acronym Olmesartan Reduces urinary Inflammatiory and Oxidative stress markers in Diabetic Nephropathy, with suppressing urinary Angiotensinogen elevation. ORION-Angel Study
Scientific Title An open label multi facilities cooperation randomized control trial to verify urinary angiotensinogen excretion reducing effect of olmesartan therapy in diabetic nephropathy.
Scientific Title:Acronym Olmesartan Reduces urinary Inflammatiory and Oxidative stress markers in Diabetic Nephropathy, with suppressing urinary Angiotensinogen elevation. ORION-Angel Study
Region
Japan

Condition
Condition Hypertensive type2 diabetic nephropathy patients with chronic kidney disease (CKD)
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the follow hypothesis.: Administration of an Olmesartan, which is an angiotensin II receptor blocker, reduces urinary angiotensinogen excretion, and suppresses oxidative stress and the inflammations with suppressing urinary albumin excretion.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Changes of urinary angiotensinogen excretion, monocyte chemoattractant protein (MCP)-1, interleukin (IL)-6, 8-epi prostaglandin F2alpha 8-hydroxydeoxyguanosine, albumin excretion (albumin to creatinine ratio: ACR) and blood pressure.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 This Study is a prospective randomized control trial. The entry period of this study is one year. Subjects are hypertensive diabetic nephropathy, who has not been taken RAS inhibitors. The patients are randomly assigned to two groups, a Olmesartan group (20mg/day or 40 mg/day) and Nifedipine CR group (20 mg/day or 40 mg/day). Both drugs can be properly increased to 40 mg/day, when the anti-hypertensive effect is insufficient.
Interventions/Control_2 The subjects were given Olmesartan or Nifedipine CR, and the following parameters were measured before administration and 16 weeks later: blood pressure, body weight, hemoglobin A1c, serum creatinine, urinary angiotensinogen, oxidative stress markers such as 8-epi-prostaglandinF2alpha and 8-hydroxydeoxyguanosine, inflammatory makers such as monocyte chemoattractant protein-1, interleukin-6, and albumin-to-creatinine ratio (ACR).
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
80 years-old >=
Gender Male and Female
Key inclusion criteria The subjects enrolled in the present study are hypertensive type 2 diabetic outpatients with nephropathy, who visit our hospitals and fulfilled the following criteria: 1) mild or moderate hypertension (blood pressure 130-200/90-110 mmHg) 2) mild or moderate hyperglycemia (HbA1c < 8%) 3) an urinary albumin excretion higher than 30 mg/g creatinine.
Key exclusion criteria 1) A serum creatinine level is more than 2.5 mg/dl and existence of hematuria. 2) A patient who has received continuous dialysis. 3) With severe diabetic complications such as retinal hemorrhage, neuropathy, and so on. 4) Existence of severe hepatic damages, and cerebrovascular disorders including heart failure. 5) A severe hypertensive patient (BP > 200/110 mmHg). 6) Use of rennin angiotensin system (RAS) inhibitors.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sadayoshi Ito MD,PhD
Organization Tohoku University Graduate School of Medicine
Division name Division of Nephrology,Rndocrinology and Vascular Medicine Department of Internal Medicine
Zip code
Address 1-1 Seiryo-cho Aoba-ku, Sendai, 980-8574 Japan
TEL 022-717-7163
Email

Public contact
Name of contact person
1st name
Middle name
Last name Susumu Ogawa MD,PhD
Organization Tohoku University Hospital
Division name Division of Nephrology, Endocrinology and Hypertension
Zip code
Address 1-1 Seiryo-cho Aoba-ku, Sendai, 980-8574 Japan
TEL 022-717-7166
Homepage URL
Email ogawa-s@hosp.tohoku.ac.jp

Sponsor
Institute Graduate School of Medicine, Tohoku University
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
2009 Year 03 Month 09 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 Completed
Date of protocol fixation
2009 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2011 Year 08 Month 01 Day
Date of closure to data entry
2012 Year 04 Month 01 Day
Date trial data considered complete
2012 Year 04 Month 01 Day
Date analysis concluded
2012 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 01 Month 06 Day
Last modified on
2015 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001946

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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