Diabetic Kidney DiseaseNCT00212901
High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy
A study testing High dose ACE-I vs ARB in people with Diabetic Kidney Disease, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective in decreasing amount of protein in urine in patients with diabetic kidney disease than high doses of trandolapril. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- High dose ACE-I vs ARB
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2004to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Early diabetic nephropathy as defined by proteinuria between 500mg/24hr and 3g/24hr and GFR\>50ml/min (as calculated by the Cockcroft-Gault formula), in the absence of clinical and laboratory evidence of other non-diabetic renal disease.
- Controlled blood pressure (\<150/\<90)
- Able to give informed consent
- Between the ages of 18 and 75
- Must be capable of providing a 24 hour urine collection
- Negative BHcG test for ruling out pregnancy in women of childbearing age
- Currently taking an angiotensin converting enzyme inhibitor
- -
Who cannot join
- Creatinine clearance \<50ml/min or 24hour protein excretion \>3gm/d.
- Hypotension as defined by the inability to add an ARB or increase ACE-I dose secondary to hypotensive symptomatology or a systolic Bp \<100mmHg.
- Serum potassium \>5.5 on two separate occasions in the previous six months
- Previous adverse reaction to angiotensin receptor antagonist medication
- Use of NSAIDS including COX2 inhibitors
- Pregnant or nursing women will be excluded
- Currently taking an angiotensin receptor antagonist
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addition of Angiotensin Receptor Blockade to ACE Inhibition Versus High Dose ACE Inhibition for Reduction of Proteinuria in Patients With Diabetic Nephropathy
Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective in decreasing amount of protein in urine in patients with diabetic kidney disease than high doses of trandolapril.
- Conditions
- Diabetic Kidney Disease
- Being tested
- High dose ACE-I vs ARB
- Keywords
- Diabetes, Proteinuria, Angiotensin converting enzyme inhibitors, Angiotensin receptor antagonists
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose ACE-I vs ARBDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
reducing proteinuria
Secondary outcomes (2)
glomerular filtration rate
side-effects of hypotension, postural symptom
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Ayub Akbari, MD, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212901
- Sponsor's protocol ID
- 2004482-01
- Status last verified
- Jul 2007
- First submitted
- 13 Sep 2005
- Last updated
- 26 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Angiotensin Receptor Blockade to ACE Inhibition Versus High Dose ACE Inhibition for Reduction of Proteinuria in Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00212901
- Acronym / sponsor ID
- 2004482-01
- Conditions
- Diabetic Kidney Disease
- Keywords
- Diabetes, Proteinuria, Angiotensin converting enzyme inhibitors, Angiotensin receptor antagonists
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Aug 2004
- Study completion
- Sep 2006 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective in decreasing amount of protein in urine in patients with diabetic kidney disease than high doses of trandolapril.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Early diabetic nephropathy as defined by proteinuria between 500mg/24hr and 3g/24hr and GFR\>50ml/min (as calculated by the Cockcroft-Gault formula), in the absence of clinical and laboratory evidence of other non-diabetic renal disease.
- Controlled blood pressure (\<150/\<90)
- Able to give informed consent
- Between the ages of 18 and 75
- Must be capable of providing a 24 hour urine collection
Key exclusion criteria (8 listed)
- Creatinine clearance \<50ml/min or 24hour protein excretion \>3gm/d.
- Hypotension as defined by the inability to add an ARB or increase ACE-I dose secondary to hypotensive symptomatology or a systolic Bp \<100mmHg.
- Serum potassium \>5.5 on two separate occasions in the previous six months
- Previous adverse reaction to angiotensin receptor antagonist medication
- Use of NSAIDS including COX2 inhibitors
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 |
|---|---|---|
| High dose ACE-I vs ARB | Drug | – |
Primary outcome
reducing proteinuria
2 secondary outcomes
glomerular filtration rate
side-effects of hypotension, postural symptom
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2007.
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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.
Ayub Akbari, MD principal investigator
OHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose ACE-I vs ARB in people with Diabetic Kidney Disease, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 8 inclusion and 8 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 26 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
reducing proteinuria. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2007.