Clinical trial NCT00141453: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 577
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Renal Composite Outcomes
timeFrame: Randomization to 5 years
Secondary outcomes:
measure: Number of Participants Experiencing Cardiovascular Composite Outcomes
timeFrame: Within 5 years
measure: The Change in Proteinuria
timeFrame: Randomization to 5 years
measure: Reciprocal (1/Serum Creatinine) of Serum Creatinine
timeFrame: Randomization to 5 years
Other outcomes:
Locations:
city: Hong Kong
country: China
city: Tokyo
country: Japan
Study officials:
affiliation: R&D Division, Daiichi Sankyo Co., Ltd.
name: Study Manager
role: STUDY_DIRECTOR
References:
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.
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.