Back to resultsAliskiren in Patients With Idiopathic Membranous Nephropathy
Primary Purpose
Idiopathic Membranous Nephropathy
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aliskiren
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Membranous Nephropathy focused on measuring membranous nephropathy aliskiren proteinuria, glomerulonephritis
Eligibility 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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aliskiren
Arm Description
Aliskiren dose will begin with 150mg per day and later up-titrated to the maximum available dose of 300mg per day.
Outcomes
Primary Outcome Measures
Urine protein excretion
Urine protein excretion at 12 weeks of renin inhibition with aliskiren
Secondary Outcome Measures
Blood pressure control; tolerability and side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01093781
Brief Title
Aliskiren in Patients With Idiopathic Membranous Nephropathy
Official Title
A Pilot Study to Evaluate the Antiproteinuric Effect of Renin Inhibition With Aliskiren in Patients With Idiopathic Membranous Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Manufacturer asked to close study due to AEs experienced by subjects in other studies.
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Membranous Nephropathy
Keywords
membranous nephropathy aliskiren proteinuria, glomerulonephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aliskiren
Arm Type
Experimental
Arm Description
Aliskiren dose will begin with 150mg per day and later up-titrated to the maximum available dose of 300mg per day.
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Other Intervention Name(s)
Tekturna
Intervention Description
Aliskiren dose will begin with 150mg per day and later up-titrated to the maximum available dose of 300mg per day.
Primary Outcome Measure Information:
Title
Urine protein excretion
Description
Urine protein excretion at 12 weeks of renin inhibition with aliskiren
Time Frame
one year
Secondary Outcome Measure Information:
Title
Blood pressure control; tolerability and side effects
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Fervenza, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Aliskiren in Patients With Idiopathic Membranous Nephropathy
We'll reach out to this number within 24 hrs