To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy

A Single-blind, Double Dummy, Randomized, Multi-dose, Two Sequence, Crossover, Study to Investigate the Effects of Renin Inhibitor (Aliskiren 300 mg) on Albuminuria in Non-diabetic Nephropathy Patients Treated With Ramipril 10 mg and Volume Intervention (ARIA)

The study is designed to primarily assess the effect of aliskiren on albuminuria in patients with non-diabetic nephropathy when treated with ramipril and volume intervention.

Inclusion Criteria:

• Male and female subjects, age 18 years and above
• Patients with chronic kidney disease of non-diabetic origin
• Glomerular filtration rate >30 ml/min/1.73m2
• Patients with a history of hypertension and msSBP (mean systolic blood pressure) of <160 mm Hg and msDBP (mean diastolic blood pressure) <105 mm Hg at screening and baseline.
• Subjects must have a body mass index (BMI) within the range of 18 and 35 kg/m2

Exclusion Criteria:

• Previously treated (within 3 months of screening) with aliskiren or a combination of aliskiren and ramipril.
• Severe hypertension (msDBP ≥110 mmHg and msSBP ≥180 mmHg)
• Pregnant or nursing (lactating) women,
• A medical history of unstable coronary artery disease, myocardial infarction, coronary bypass surgery or cerebrovascular accident within the last six (6) months
• Diabetes mellitus, Heart failure
• High rate of renal function loss
• History of severe hypersensitivity or contraindications to any of the medications or drugs belonging to the similar therapeutic class as the study drugs and the excipients.
• History of liver disease, positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
• History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.

Other protocol-defined inclusion/exclusion criteria applied