NCT01219413

Influence of Aliskiren on Proteinuria

The Effect of Aliskiren on Proteinuria in Chronic Nondiabetic Kidney Disease: a Double Blind Cross-over Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the proteinuria lowering efficacy as well as tolerability and safety of the renin inhibitor aliskiren compared with that of placebo and angiotensin converting enzyme inhibitor perindopril in patients with non-diabetic chronic renal disease.

Detailed description

Proteinuria is a major risk factor for progression to end-stage renal disease in both diabetic and nondiabetic nephropathies. Angiotensin II and aldosterone are the key players in the development of renal failure, either directly by promoting tissue fibrosis or indirectly through their action on glomerular hemodynamic and proteinuria. Therefore, pharmacological inhibition of the renin-angiotensin-aldosterone system (RAAS) may have a beneficial impact on proteinuria and chronic kidney diseases progression. Recently, renin inhibitors, a new class of drugs that selectively inhibits angiotensin II formation at the first step of the RAAS cascade has been introduced to clinical practice. Aliskiren is the first orally bioavailable direct renin inhibitor approved for the treatment of hypertension. Blood pressure (BP)-lowering effect of aliskiren is associated with a decreased generation of angiotensin I, as it blocks its generation from angiotensinogen, by inhibiting the active enzymatic site of renin. The investigators plan this study to evaluate the short-term effects of treatment with aliskiren to those of placebo and ACEI perindopril on proteinuria.

Conditions

• Chronic Kidney Disease
• Proteinuria
• Blood Pressure

Interventions

Type	Name	Description
DRUG	Aliskiren, Perindopril	Rasilez 300 mg Prestarium 10 mg

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-07-01
• Completion: 2010-09-01
• First posted: 2010-10-13
• Last updated: 2015-09-24

Locations

1 site across 1 country: Poland