UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001618 |
|---|---|
| Receipt number | 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 | 2022/04/06 10:56:40 |
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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 | Sadayoshi |
| Middle name | |
| Last name | Ito |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Nephrology,Rndocrinology and Vascular Medicine Department of Internal Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7163
ogawa-s@hosp.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University Hospital
Division name
Division of Nephrology, Endocrinology and Hypertension
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7166
Homepage URL
ogawa-s@hosp.tohoku.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Tohoku University
Institute
Department
Personal name
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574 Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 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
| 2022 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001946
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