Back to resultsORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial
Primary Purpose
Diabetic Nephropathy, Type 2 Diabetes Mellitus, Proteinuria
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
olmesartan medoxomil
Placebo Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathy focused on measuring angiotensin II type I receptor blockers, diabetic nephropathy, end-stage renal disease, renal failure, type 2 diabetes, olmesartan medoxomil
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of diabetic nephropathy in patients with type 2 diabetes albumin-to-creatinine ratio >= 300 mg/g creatinine in first morning urinalysis serum creatinine between 1.0 and 2.5 mg/dL in women and between 1.2 and 2.5 mg/dL in men Exclusion Criteria: type 1 diabetes non-diabetic nephropathy history of myocardial infarction history of cardiac bypass grafting within 3 months history of percutaneous coronary intervention (PCI) within 6 months history of carotid artery or peripheral artery revascularization within 6 months stroke or transient ischemic attack (TIA) within 1 year unstable angina pectoris heart failure of NYHA functional classes III or IV rapid progression of kidney disease within 3 months severe orthostatic hypotension serum potassium level =<3.5 mEq(mmol)/L or =>5.5 mEq(mmol)L history of rapid elevation of the serum creatinine level after starting treatment with AII receptor antagonists or ACE inhibitors poor glycemic control: HbA1c level =>11% history of myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Olmesartan medoxomil tablets 10mg to 40 mg
Matching placebo tablets
Outcomes
Primary Outcome Measures
Renal Composite Outcomes
first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease
Secondary Outcome Measures
Number of Participants Experiencing Cardiovascular Composite Outcomes
Number of participants experiencing the first occurence of any of the following: Cardiovascular death; non-fatal stroke; non-fatal myocardial infarction; hospitalization for unstable angina; lower extremity amputation; coronary/carotid/peripheral revascularization.
The Change in Proteinuria
The median percentage change from baseline value in urinary protein:creatinine ratio
Reciprocal (1/Serum Creatinine) of Serum Creatinine
The amount of serum creatinine was determined by blood tests periodically during the study. The amount of creatinine is an indication of kidney function. The reciprocal of serum creatinine is used in an equation to determine the change in kidney function from baseline. The reciprocal of the serum creatinine was monitored to detect kidney function changes over duration of the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00141453
Brief Title
ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial
Official Title
CS-866DM Phase 3 Clinical Study: A Double-Blind Controlled Trial in Patients With Diabetic Nephropathy and Overt Proteinuria Secondary to Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Daiichi Sankyo Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy, Type 2 Diabetes Mellitus, Proteinuria
Keywords
angiotensin II type I receptor blockers, diabetic nephropathy, end-stage renal disease, renal failure, type 2 diabetes, olmesartan medoxomil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
577 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Olmesartan medoxomil tablets 10mg to 40 mg
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil
Intervention Description
Tablets 10, 20, or 40 mg
Intervention Type
Drug
Intervention Name(s)
Placebo Tablets
Intervention Description
Matching placebo tablets
Primary Outcome Measure Information:
Title
Renal Composite Outcomes
Description
first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease
Time Frame
Randomization to 5 years
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing Cardiovascular Composite Outcomes
Description
Number of participants experiencing the first occurence of any of the following: Cardiovascular death; non-fatal stroke; non-fatal myocardial infarction; hospitalization for unstable angina; lower extremity amputation; coronary/carotid/peripheral revascularization.
Time Frame
Within 5 years
Title
The Change in Proteinuria
Description
The median percentage change from baseline value in urinary protein:creatinine ratio
Time Frame
Randomization to 5 years
Title
Reciprocal (1/Serum Creatinine) of Serum Creatinine
Description
The amount of serum creatinine was determined by blood tests periodically during the study. The amount of creatinine is an indication of kidney function. The reciprocal of serum creatinine is used in an equation to determine the change in kidney function from baseline. The reciprocal of the serum creatinine was monitored to detect kidney function changes over duration of the study.
Time Frame
Randomization to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of diabetic nephropathy in patients with type 2 diabetes
albumin-to-creatinine ratio >= 300 mg/g creatinine in first morning urinalysis
serum creatinine between 1.0 and 2.5 mg/dL in women and between 1.2 and 2.5 mg/dL in men
Exclusion Criteria:
type 1 diabetes
non-diabetic nephropathy
history of myocardial infarction
history of cardiac bypass grafting within 3 months
history of percutaneous coronary intervention (PCI) within 6 months
history of carotid artery or peripheral artery revascularization within 6 months
stroke or transient ischemic attack (TIA) within 1 year
unstable angina pectoris
heart failure of NYHA functional classes III or IV
rapid progression of kidney disease within 3 months
severe orthostatic hypotension
serum potassium level =<3.5 mEq(mmol)/L or =>5.5 mEq(mmol)L
history of rapid elevation of the serum creatinine level after starting treatment with AII receptor antagonists or ACE inhibitors
poor glycemic control: HbA1c level =>11%
history of myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Manager
Organizational Affiliation
R&D Division, Daiichi Sankyo Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Hong Kong
Country
China
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24013685
Citation
Imai E, Haneda M, Chan JC, Yamasaki T, Kobayashi F, Ito S, Makino H. Reduction and residual proteinuria are therapeutic targets in type 2 diabetes with overt nephropathy: a post hoc analysis (ORIENT-proteinuria). Nephrol Dial Transplant. 2013 Oct;28(10):2526-34. doi: 10.1093/ndt/gft249. Epub 2013 Sep 7.
Results Reference
derived
PubMed Identifier
21993710
Citation
Imai E, Chan JC, Ito S, Yamasaki T, Kobayashi F, Haneda M, Makino H; ORIENT study investigators. Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study. Diabetologia. 2011 Dec;54(12):2978-86. doi: 10.1007/s00125-011-2325-z. Epub 2011 Oct 13.
Results Reference
derived
Learn more about this trial
ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial
We'll reach out to this number within 24 hrs