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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Non-diabetic Nephropathy

Treatments: Drug: Ramipril; Drug: Aliskiren; Drug: Placebo to Hydrochlorothiazide (HCTZ); Drug: Placebo to Aliskiren; Drug: Hydrochlorothiazide (HCTZ)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01302899

CSPP100A2260

2009-012196-10 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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8 participants in 2 patient groups

Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram

Experimental group

Description:

Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d. Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d. Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.

Treatment:

Drug: Placebo to Aliskiren

Drug: Placebo to Hydrochlorothiazide (HCTZ)

Drug: Aliskiren

Drug: Hydrochlorothiazide (HCTZ)

Drug: Ramipril

Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram

Experimental group

Description:

Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d. Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d. Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d. Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.

Treatment:

Drug: Placebo to Aliskiren

Drug: Placebo to Hydrochlorothiazide (HCTZ)

Drug: Aliskiren

Drug: Hydrochlorothiazide (HCTZ)

Drug: Ramipril