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Completed

NCT Number: NCT00141453

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

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

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Key information

Conditions

Diabetic Nephropathy Chronic Disease Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Nephropathies Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteinuria Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Type 2 Diabetes Mellitus Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hong Kong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

olmesartan medoxomil

Drug

Tablets 10, 20, or 40 mg

Placebo tablets

Drug

Matching placebo tablets

Primary outcomes

  1. Renal Composite Outcomes

    Time frame: Randomization to 5 years

    first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease

Secondary outcomes

  1. Number of Participants Experiencing Cardiovascular Composite Outcomes

    Time frame: 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.

  2. The Change in Proteinuria

    Time frame: Randomization to 5 years

    The median percentage change from baseline value in urinary protein:creatinine ratio

  3. Reciprocal (1/Serum Creatinine) of Serum Creatinine

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2008
Study completion
2009
First posted
Sep 1, 2005
Registry last updated
May 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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