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

Phase 3

Completed

• Conditions: Diabetic Nephropathy; Type 2 Diabetes Mellitus; Proteinuria
• Interventions: Drug: olmesartan medoxomil; Drug: Placebo Tablets

• Registration Number: NCT00141453
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-01
• Primary Completion: 2008-08
• Study Completion: 2009-01
• Results First Submitted: 2009-08-31
• Status Verified: 2011-05
• Results First Submitted QC: 2011-05-09
• Last Update Submitted: 2011-05-09
• Results First Posted: 2011-05-10
• Last Update Posted: 2011-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 577

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	olmesartan medoxomil	Olmesartan medoxomil tablets 10mg to 40 mg
2	Placebo Tablets	Matching placebo tablets

Primary Outcome Measures

Name	Time	Method
Renal Composite Outcomes	Randomization to 5 years	first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Cardiovascular Composite Outcomes	Within 5 years	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	Randomization to 5 years	The median percentage change from baseline value in urinary protein:creatinine ratio
Reciprocal (1/Serum Creatinine) of Serum Creatinine	Randomization to 5 years	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.