ARIA (Atacand Renoprotection In NephropAthy Pt.)

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Non-diabetic Nephropathy With Hypertension

Intervention / Treatment
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* Drug: Candesartan Cilexetil
* Drug: Candesartan Cilexetil
* Drug: Candesartan Cilexetil 32mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Current serum-creatinine > 265 mmol/L (>3 mg/dL). Current serum-potassium > 5.5 mmol/L Known hypersensitivity to angiotensin (AT)1-receptor blocker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Candesartan Cilexetil | Drug: Candesartan Cilexetil<br>* 8 mg oral once daily dose<br>* Other names: Atacand;|
| Experimental: 2<br>Candesartan Cilexetil | Drug: Candesartan Cilexetil<br>* 16 mg oral once daily dose<br>* Other names: Atacand;|
| Experimental: 3<br>Candesartan Cilexetil | Drug: Candesartan Cilexetil 32mg<br>* 32 mg oral once daily dose<br>* Other names: Atacand;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks | Decrease of urinary protein/creatinine ratio means improvement of renal disease. | baseline to 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Systolic and Diastolic Blood Pressure From Baseline |  | baseline to 28 weeks | 
| Inflammatory Marker (Hs-C-peptide Reactive Protein) | To evaluate how to reduce and relate with cardiovascular risk | 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) | 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. | Baseline to 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Candesartan Cilexetil, Non-diabetic Nephropathy, hypertension, urine protein creatinine ratio