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

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Hydrochlorothiazide; Ramipril

Criteria

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