A Study of the Effects of Aliskiren in Patients with Idiopathic Membranous Nephropathy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 09-007837
NCT ID: NCT01093781
Sponsor Protocol Number: 09-007837
About this study
The purpose of this study is to assess the effect of aliskiren to keep protein from spilling into the urine in patients who have idiopathic membranous nephropathy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Idiopathic Membranous Nephropathy proven by diagnostic kidney biopsy
- Age ≥18 years but ≤ 80
- 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
- Must be off prednisone, calcineurin inhibitor or mycophenolate mofetil for > 1 month and alkylating agents for > 6 months
- 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
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available