Clinical trial NCT01302899: To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-diabetic Nephropathy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-02-24
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER)
timeFrame: 26 weeks
measure: Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin
timeFrame: 26 weeks
Secondary outcomes:
measure: Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: 26 weeks
measure: Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: 26 weeks
measure: Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function
timeFrame: 26 weeks
measure: Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments
timeFrame: 26 weeks
measure: Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments
timeFrame: 26 weeks
measure: Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments
timeFrame: 26 weeks
measure: Plasma Rennin Activity (PRA)
timeFrame: Baseline to week 26
measure: Plasma Rennin Concentration (PRC)
timeFrame: Baseline to week 26
measure: Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Leeuwarden
country: Netherlands
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: