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

NCT00141453 | Completed Phase 3 Results

• 1 other identifier: ORIENT
• Study Type: interventional
• Target: 577
• Locations: 2 countries
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants Experiencing Cardiovascular Composite Outcomes

  Within 5 years

• The Change in Proteinuria

  Randomization to 5 years

• Reciprocal (1/Serum Creatinine) of Serum Creatinine

  Randomization to 5 years

Study Arms (2)

1

EXPERIMENTAL

Olmesartan medoxomil tablets 10mg to 40 mg

Drug: olmesartan medoxomil

2

PLACEBO COMPARATOR

Matching placebo tablets

Drug: Placebo Tablets

Interventions

olmesartan medoxomil DRUG

Tablets 10, 20, or 40 mg

1

Placebo Tablets DRUG

Matching placebo tablets

2

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (2)

Unknown Facility

Hong Kong, China

Location

Unknown Facility

Tokyo, Japan

Location

Related Publications (3)

• Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.

  PMID: 38682786 DERIVED

• 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.

  PMID: 24013685 DERIVED

• 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.

  PMID: 21993710 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus, Type 2; Proteinuria; Kidney Failure, Chronic; Renal Insufficiency

Interventions

Olmesartan Medoxomil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Results Point of Contact

• Title: Howard Kessler
• Organization: Daiichi Sankyo, Inc

hmkessler@dsi.com

732-590-5032

Study Officials

• Study Manager

  R&D Division, Daiichi Sankyo Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 1, 2005
• Study Start: April 1, 2003
• Primary Completion: August 1, 2008
• Study Completion: January 1, 2009
• Last Updated: May 10, 2011
• Results First Posted: May 10, 2011

Record last verified: 2011-05

Locations

CN (1); JP (1)