Clinical Trial: Aliskiren in Patients With Idiopathic Membranous Nephropathy

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Pilot Study to Evaluate the Antiproteinuric Effect of Renin Inhibition With Aliskiren in Patients With Idiopathic Membranous Nephropathy

Brief Summary: The goal of this proposal is to conduct a pilot study to access the antiproteinuric effect of aliskiren in patients with idiopathic membranous nephropathy. Patients will be treated for 3 months with aliskiren aiming to achieve the maximum tolerated dose and blood pressure (>100 but <125 mmHg systolic BP >75% of the readings).

Detailed Summary:

In patients with nephrotic syndrome, including patients with membranous nephropathy (MN), conservative therapy consists of restricting dietary protein intake, and controlling blood pressure (target blood pressure is ≤ 125/75 mmHg), hyperlipidemia, and edema. Angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) are effective anti-hypertensive agents that can reduce proteinuria and slow progression of renal disease in both diabetic and nondiabetic chronic nephropathy patients and for these reasons they are the preferred agents to treat hypertension in proteinuric renal diseases.

Recent studies suggest that renin inhibition with aliskiren may be renoprotective and reduce proteinuria in patients with type 2 diabetes. Similar observations have also been reported in patients with membranous nephropathy and proteinuria in the range of 1-3 g/24h. These observations suggest that aliskiren may have powerful antiproteinuric. However, it is important to emphasize, that none of the patients in these studies had proteinuria greater than 3.0 g/24h. Thus, the antiproteinuric effect of aliskiren in patients with heavy proteinuria (e.g. >4g/24h) is unknown.


Sponsor: Mayo Clinic

Current Primary Outcome: Urine protein excretion [ Time Frame: one year ]

Urine protein excretion at 12 weeks of renin inhibition with aliskiren


Original Primary Outcome: Same as current

Current Secondary Outcome: Blood pressure control; tolerability and side effects [ Time Frame: one year ]

Original Secondary Outcome: Blood pressure control; tolerabillity and side effects [ Time Frame: one year ]

Information By: Mayo Clinic

Dates:
Date Received: March 24, 2010
Date Started: November 2010
Date Completion:
Last Updated: March 12, 2013
Last Verified: March 2013