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)

NCT01302899 Phase 2 TERMINATED Results posted

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.

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	TERMINATED
Enrolment	8
Start date	2011-01
Completion	2011-12

Conditions

• Non-diabetic Nephropathy

Interventions

• Aliskiren
• Placebo to Aliskiren
• Hydrochlorothiazide (HCTZ)
• Placebo to Hydrochlorothiazide (HCTZ)
• Ramipril

Primary outcomes

• Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER) — 26 weeks
  Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.
• Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin — 26 weeks
  Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.

Countries

Netherlands