ARIA(Atacand Renoprotection In NephropAthy Pt.)

Condition(s) targeted: Non-Diabetic Nephropathy With Hypertension

Intervention: Candesartan Cilexetil (Drug); Candesartan Cilexetil (Drug); Candesartan Cilexetil 32mg (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Da Suk Han, Principal Investigator, Affiliation: Severance Hospital

Overall contact:
AstraZeneca Korea Clinical Study, Information, Phone: 82 2 2188 0951, Email: minjee.nam@astrazeneca.com

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: 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

Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in urinary protein/creatinine ratio

Secondary outcome:

Systolic and diastolic blood pressure

Inflammatory marker (hs-CRP)

Estimated GFR predicted from the Modification of Diet in Renal Disease (MDRD) equation

Safety

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. hypertension; a)135mmHg 2. proteinuria(urinary protein/creatinine ratio between 500mg/g and 5000mg/g)

Exclusion Criteria:

1. Current serum-creatinine >265 mmol/L (>3 mg/dL).

2. Current serum-potassium >5. 5mmol/L

3. Known hypersensitivity to AT1-receptor blocker

AstraZeneca Korea Clinical Study, Information, Phone: 82 2 2188 0951, Email: minjee.nam@astrazeneca.com

Research Site, Seoul, Korea, Republic of; Recruiting

Starting date: December 2007
Ending date: November 2009
Last updated: November 24, 2008