ARIA (Atacand Renoprotection In NephropAthy Pt.)

AstraZeneca128 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

128

Conditions

Non-diabetic Nephropathy With Hypertension

Interventions

Candesartan CilexetilDRUG

8 mg oral once daily dose

Candesartan CilexetilDRUG

16 mg oral once daily dose

Candesartan Cilexetil 32mgDRUG

32 mg oral once daily dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Seoul, South Korea

Outcomes

Primary Outcomes

The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks

Decrease of urinary protein/creatinine ratio means improvement of renal disease.

Time frame: baseline to 28 weeks

Secondary Outcomes

Change of Systolic and Diastolic Blood Pressure From Baseline

Time frame: baseline to 28 weeks

Inflammatory Marker (Hs-C-peptide Reactive Protein)

To evaluate how to reduce and relate with cardiovascular risk

Time frame: 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)

Time frame: 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.

Time frame: Baseline to 28 weeks

Data from ClinicalTrials.gov

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