Non-diabetic Nephropathy With HypertensionPhase 4PCRNCT00573430
ARIA (Atacand Renoprotection In NephropAthy Pt.)
A Phase 4 study testing Candesartan Cilexetil and Candesartan Cilexetil 32mg in people with Non-diabetic Nephropathy With Hypertension, run by AstraZeneca at 1 site in South Korea.
Trial summary
To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-diabetic Nephropathy With Hypertension
- What is being tested?
- Candesartan Cilexetil and Candesartan Cilexetil 32mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2007to Aug 2009
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hypertension; a)135mmHg < Systolic Blood Pressure <180mmHg and/or 85 mmHg < Diastolic Blood Pressure <100 mmHg. or b) The subject has been treated with antihypertensive medication
- proteinuria (urinary protein/creatinine ratio between 500 mg/g and 5000 mg/g)
Who cannot join
- Current serum-creatinine > 265 mmol/L (>3 mg/dL).
- Current serum-potassium > 5.5 mmol/L
- Known hypersensitivity to angiotensin (AT)1-receptor blocker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 28-week, Randomised, Open-label, Parallel-Group, Multi-Center Study To Find the Effective Dose of Candesartan Cilexetil (Atacand) for Renoprotection in Korean Hypertensive Patients With Non-diabetic Nephropathy
To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week treatment
- Being tested
- Candesartan Cilexetil, Candesartan Cilexetil 32mg
- Keywords
- Candesartan Cilexetil, Non-diabetic Nephropathy, hypertension, urine protein creatinine ratio
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan CilexetilDrug
Also called Atacand
8 mg oral once daily dose
Candesartan CilexetilDrug
Also called Atacand
16 mg oral once daily dose
Candesartan Cilexetil 32mgDrug
Also called Atacand
32 mg oral once daily dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Candesartan Cilexetil Receives: Drug: Candesartan Cilexetil |
| 2 | Experimental | Candesartan Cilexetil Receives: Drug: Candesartan Cilexetil |
| 3 | Experimental | Candesartan Cilexetil Receives: Drug: Candesartan Cilexetil 32mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks
Decrease of urinary protein/creatinine ratio means improvement of renal disease.
Measured: baseline to 28 weeks
Secondary outcomes (4)
Change of Systolic and Diastolic Blood Pressure From Baseline
Measured: baseline to 28 weeks
Inflammatory Marker (Hs-C-peptide Reactive Protein)
To evaluate how to reduce and relate with cardiovascular risk
Measured: baseline to 28 weeks
Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation
GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units)
Measured: 28 weeks
Treatment-emergent Adverse Events
Prevalence of adverse events after treatment regardless causality. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition from the signing of the informed consent, whether or not considered causally related to the product.
Measured: Baseline to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionAug 2009
- Study completionAug 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.
- Other trials for Non-diabetic Nephropathy With HypertensionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Da Suk Han, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573430
- Sponsor's protocol ID
- D2452L00015
- Acronym
- PCR
- Status last verified
- Aug 2011
- First submitted
- 13 Dec 2007
- Last updated
- 23 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 28-week, Randomised, Open-label, Parallel-Group, Multi-Center Study To Find the Effective Dose of Candesartan Cilexetil (Atacand) for Renoprotection in Korean Hypertensive Patients With Non-diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00573430
- Acronym / sponsor ID
- PCR / D2452L00015
- Keywords
- Candesartan Cilexetil, Non-diabetic Nephropathy, hypertension, urine protein creatinine ratio
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Posted 19 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Candesartan CilexetilCandesartan Cilexetil |
| 2 | Experimental | Drug: Candesartan CilexetilCandesartan Cilexetil |
| 3 | Experimental | Drug: Candesartan Cilexetil 32mgCandesartan Cilexetil |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hypertension; a)135mmHg < Systolic Blood Pressure <180mmHg and/or 85 mmHg < Diastolic Blood Pressure <100 mmHg. or b) The subject has been treated with antihypertensive medication
- proteinuria (urinary protein/creatinine ratio between 500 mg/g and 5000 mg/g)
Key exclusion criteria (3 listed)
- Current serum-creatinine > 265 mmol/L (>3 mg/dL).
- Current serum-potassium > 5.5 mmol/L
- Known hypersensitivity to angiotensin (AT)1-receptor blocker
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 CilexetilAlso: Atacand8 mg oral once daily dose | Drug | 1 |
| Candesartan CilexetilAlso: Atacand16 mg oral once daily dose | Drug | 2 |
| Candesartan Cilexetil 32mgAlso: Atacand32 mg oral once daily dose | Drug | 3 |
Primary outcome
The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks
Time frame: baseline to 28 weeks
Decrease of urinary protein/creatinine ratio means improvement of renal disease.
4 secondary outcomes
Change of Systolic and Diastolic Blood Pressure From Baseline
Time frame: baseline to 28 weeks
Inflammatory Marker (Hs-C-peptide Reactive Protein)
Time frame: baseline to 28 weeks
Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation
Time frame: 28 weeks
Treatment-emergent Adverse Events
Time frame: Baseline to 28 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Da Suk Han principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Candesartan Cilexetil and Candesartan Cilexetil 32mg in people with Non-diabetic Nephropathy With Hypertension, run by AstraZeneca at 1 site in South Korea.
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 2 inclusion and 3 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 23 Aug 2011. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 19 Jul 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?
The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks (time frame: baseline to 28 weeks). 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 23 Aug 2011; AzTrials last refreshed its copy on 6 Nov 2026.