ProteinuriaPhase 3NCT00242346
High Doses of Candesartan Cilexetil on the Reduction of Proteinuria
A Phase 3 study testing candesartan cilexetil in people with Proteinuria, run by AstraZeneca at 26 sites in Canada.
Trial summary
The purpose of this study is to assess the effects of high doses of candesartan cilexetil and also to assess which dose (16mg, 64mg, 128mg) is the most optimal for the maximum reduction of proteinuria. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Proteinuria
- What is being tested?
- candesartan cilexetil
- How many people
- 270 participants
- Where
- 26 sitesCanada
- Study dates
- Apr 2003to Dec 2006
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Stable hypertension defined as no new antihypertensive medication started within 6 weeks of Visit 1
- Minimum 6-month history of hypertension and primary glomerular disease
- Hypertensive nephrosclerosis
- Diabetic nephropathy with stable proteinuria as defined by ≥ 1g/24 hours on more than one occasion within 6 months prior to Visit 1
Who cannot join
- Persistent hypertension
- New anti-hypertensive medications started within 6 weeks of Visit 1
- Significant cardiac disease or Liver disease
- Females of childbearing potential without reliable contraception
- Pregnant women and women who are breast-feeding
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Canada26 sites
Research Site
Calgary, Alberta
Research Site
Courtice, Ontario
Research Site
Edmonton, Alberta
Research Site
Greater Sudbury, Ontario
Research Site
Greenfield Park, Quebec
Research Site
Halifax, Nova Scotia
Research Site
Kelowna, British Columbia
Research Site
Kitchener, Ontario
Research Site
Laval, Quebec
Research Site
London, Ontario
Research Site
Mississauga, Ontario
Research Site
Montreal, Quebec
Research Site
Oakville, Ontario
Research Site
Oshawa, Ontario
Research Site
Québec, Quebec
Research Site
Richmond Hill, Ontario
Research Site
Saskatoon, Saskatchewan
Research Site
Scarborough Village, Ontario
Research Site
St. John's, Newfoundland and Labrador
Research Site
Ste-Foy, Quebec
Research Site
Thunder Bay, Ontario
Research Site
Timmins, Ontario
Research Site
Toronto, Ontario
Research Site
Vancouver, British Columbia
Research Site
Weston, Ontario
Research Site
Winnipeg, Manitoba
About this study
Official title: A Double-Blind, Randomised, Dose Ranging, Multi-Centre, Phase IIIb Study to Evaluate the Efficacy and Safety of High Doses of Candesartan Cilexetil (Atacand®) on the Reduction of Proteinuria in the Treatment of Subjects With Hypertension and Moderate to Severe Proteinuria
The purpose of this study is to assess the effects of high doses of candesartan cilexetil and also to assess which dose (16mg, 64mg, 128mg) is the most optimal for the maximum reduction of proteinuria.
- Conditions
- Proteinuria
- Being tested
- candesartan cilexetil
- Keywords
- Hypertension
- Medical subject headings
- Proteinuria, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
candesartan cilexetilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effects of high dose candesartan cilexetil on the overall reduction in proteinuria from baseline as evidenced by the 24-hour urine collection
Secondary outcomes (2)
To determine the effects of high dose candesartan cilexetil on renal function as measured by serum creatinine and 24-hour creatinine clearance
To determine the effects of high dose candesartan cilexetil on blood pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startApr 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ProteinuriaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 270 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kazi Borkowski, PhD, Study director, AstraZenecaNorman MuirHead, MD, Principal investigator, London HSCEllen Burgess, MD, Principal investigator, Foothills Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242346
- Sponsor's protocol ID
- D2452L00006
- Other IDs
- DC-AHS-0006, SMART
- Status last verified
- Dec 2007
- First submitted
- 18 Oct 2005
- Last updated
- 19 Dec 2007
- Results posted
- No
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 38682786Cooper TE, Teng C, Tunnicliffe DJ, Cashmore BA, Strippoli GF. Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers for adults with early (stage 1 to 3) non-diabetic chronic kidney disease. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD007751. doi: 10.1002/14651858.CD007751.pub3.
PubMed 37466151Burgess E, Muirhead N, Rene de Cotret P, Chiu A, Pichette V, Tobe S; SMART (Supra Maximal Atacand Renal Trial) Investigators. Supramaximal dose of candesartan in proteinuric renal disease. J Am Soc Nephrol. 2009 Apr;20(4):893-900. doi: 10.1681/ASN.2008040416. Epub 2009 Feb 11.
PubMed 19211712
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomised, Dose Ranging, Multi-Centre, Phase IIIb Study to Evaluate the Efficacy and Safety of High Doses of Candesartan Cilexetil (Atacand®) on the Reduction of Proteinuria in the Treatment of Subjects With Hypertension and Moderate to Severe Proteinuria
- ClinicalTrials.gov ID
- NCT00242346
- Acronym / sponsor ID
- D2452L00006
- Conditions
- Proteinuria
- Keywords
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 20 Oct 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.
The purpose of this study is to assess the effects of high doses of candesartan cilexetil and also to assess which dose (16mg, 64mg, 128mg) is the most optimal for the maximum reduction of proteinuria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent
- Stable hypertension defined as no new antihypertensive medication started within 6 weeks of Visit 1
- Minimum 6-month history of hypertension and primary glomerular disease
- Hypertensive nephrosclerosis
- Diabetic nephropathy with stable proteinuria as defined by ≥ 1g/24 hours on more than one occasion within 6 months prior to Visit 1
Key exclusion criteria (5 listed)
- Persistent hypertension
- New anti-hypertensive medications started within 6 weeks of Visit 1
- Significant cardiac disease or Liver disease
- Females of childbearing potential without reliable contraception
- Pregnant women and women who are breast-feeding
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 |
|---|---|---|
| candesartan cilexetil | Drug | – |
Primary outcome
To determine the effects of high dose candesartan cilexetil on the overall reduction in proteinuria from baseline as evidenced by the 24-hour urine collection
2 secondary outcomes
To determine the effects of high dose candesartan cilexetil on renal function as measured by serum creatinine and 24-hour creatinine clearance
To determine the effects of high dose candesartan cilexetil on blood pressure
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 19 Dec 2007.
- 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 37466151Cooper TE, Teng C, Tunnicliffe DJ, Cashmore BA, Strippoli GF. Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers for adults with early (stage 1 to 3) non-diabetic chronic kidney disease. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD007751. doi: 10.1002/14651858.CD007751.pub3.
- Derived from this study: PubMed 19211712Burgess E, Muirhead N, Rene de Cotret P, Chiu A, Pichette V, Tobe S; SMART (Supra Maximal Atacand Renal Trial) Investigators. Supramaximal dose of candesartan in proteinuric renal disease. J Am Soc Nephrol. 2009 Apr;20(4):893-900. doi: 10.1681/ASN.2008040416. Epub 2009 Feb 11.
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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.
Kazi Borkowski, PhD study director
AstraZeneca
Norman MuirHead, MD principal investigator
London HSC
Ellen Burgess, MD principal investigator
Foothills Medical Center
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing candesartan cilexetil in people with Proteinuria, run by AstraZeneca at 26 sites 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 5 inclusion and 5 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 19 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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.
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?
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?
To determine the effects of high dose candesartan cilexetil on the overall reduction in proteinuria from baseline as evidenced by the 24-hour urine collection. 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 NCT00242346, 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 19 Dec 2007.