Overview

Aliskiren in Patients With Idiopathic Membranous Nephropathy

Status:
Withdrawn
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Criteria
Inclusion Criteria

- Idiopathic MN proven by diagnostic kidney biopsy.

- Age ≥18 years but ≤ 80 years.

- Proteinuria as measured by urinary protein/urinary creatinine > 4.0 on a spot sample
aliquot from a 24-hour urine collection.

- Estimated GFR ≥ 30 ml/min/1.73m^2 using the 4 variable Modification of Diet in Renal
Disease (MDRD) equation.

Exclusion Criteria

- Age <18 years.

- Estimated Glomerular Filtration Rate (GFR) < 30 ml/min/1.73m^2, or serum creatinine
>3.0 mg/dl.

- Patient must be off prednisone, calcineurin inhibitor or mycophenolate mofetil for > 1
month and alkylating agents for > 6 months.

- Patients with presence of active infection or a secondary cause of MN (e.g. hepatitis
B, HIV, systemic lupus erythematosus (SLE), medications, malignancies).

- Type 1 or 2 diabetes mellitus. Patients who have recent history of steroid induced
diabetes but no evidence of diabetic nephropathy on renal biopsy performed within 6
months of entry into the study are eligible for enrollment.

- Pregnancy or nursing for safety reasons.

- Acute renal vein thrombosis documented prior to entry by renal US or CT scan.

- Previous therapy with Aliskiren