ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.

Official Title
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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

Conditions
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Diabetic Nephropathy, Type 2 Diabetes Mellitus, Proteinuria

Intervention / Treatment
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* Drug: olmesartan medoxomil
* Drug: Placebo Tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Olmesartan medoxomil tablets 10mg to 40 mg | Drug: olmesartan medoxomil<br>* Tablets 10, 20, or 40 mg<br>|
| Placebo Comparator: 2<br>Matching placebo tablets | Drug: Placebo Tablets<br>* Matching placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Composite Outcomes | first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease | Randomization to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 5 years | 
| The Change in Proteinuria | The median percentage change from baseline value in urinary protein:creatinine ratio | Randomization to 5 years | 
| 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. | Randomization to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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angiotensin II type I receptor blockers, diabetic nephropathy, end-stage renal disease, renal failure, type 2 diabetes, olmesartan medoxomil