Diabetic NephropathyPhase 3NCT00141453
ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial
A Phase 3 study testing olmesartan medoxomil in people with Diabetic Nephropathy and Type 2 Diabetes Mellitus, run by Daiichi Sankyo Co., Ltd. at 2 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetic Nephropathy, Type 2 Diabetes Mellitus, Proteinuria
- What is being tested?
- olmesartan medoxomil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 577 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2003to Jan 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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
- Being tested
- olmesartan medoxomil, Placebo Tablets
- Keywords
- angiotensin II type I receptor blockers, diabetic nephropathy, end-stage renal disease, renal failure, type 2 diabetes, olmesartan medoxomil
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 2, Proteinuria, Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olmesartan medoxomilDrug
Tablets 10, 20, or 40 mg
Placebo TabletsDrug
Matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Olmesartan medoxomil tablets 10mg to 40 mg Receives: Drug: olmesartan medoxomil |
| 2 | Placebo comparator | Matching placebo tablets Receives: Drug: Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Composite Outcomes
first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease
Measured: Randomization to 5 years
Secondary outcomes (3)
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.
Measured: Within 5 years
The Change in Proteinuria
The median percentage change from baseline value in urinary protein:creatinine ratio
Measured: 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.
Measured: Randomization to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionAug 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Study Manager, Study director, R&D Division, Daiichi Sankyo Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141453
- Sponsor's protocol ID
- ORIENT
- Status last verified
- May 2011
- First submitted
- 31 Aug 2005
- Last updated
- 10 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 38682786Imai 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.
PubMed 24013685Imai 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.
PubMed 21993710
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00141453
- Acronym / sponsor ID
- ORIENT
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Posted 10 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: olmesartan medoxomilOlmesartan medoxomil tablets 10mg to 40 mg |
| 2 | Placebo comparator | Drug: Placebo TabletsMatching placebo tablets |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olmesartan medoxomilTablets 10, 20, or 40 mg | Drug | 1 |
| Placebo TabletsMatching placebo tablets | Drug | 2 |
Primary outcome
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
3 secondary outcomes
Number of Participants Experiencing Cardiovascular Composite Outcomes
Time frame: Within 5 years
The Change in Proteinuria
Time frame: Randomization to 5 years
Reciprocal (1/Serum Creatinine) of Serum Creatinine
Time frame: Randomization to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38682786Natale 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.
- Derived from this study: PubMed 24013685Imai 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.
- Derived from this study: PubMed 21993710Imai 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.
Related trials for Diabetic Nephropathy
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Manager study director
R&D Division, Daiichi Sankyo Co., Ltd.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing olmesartan medoxomil in people with Diabetic Nephropathy and Type 2 Diabetes Mellitus, run by Daiichi Sankyo Co., Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Composite Outcomes (time frame: Randomization to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00141453, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2011.