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Trial record 5 of 55 for:    "Membranous nephropathy"

Aliskiren in Patients With Idiopathic Membranous Nephropathy

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ClinicalTrials.gov Identifier: NCT01093781
Recruitment Status : Withdrawn (Manufacturer asked to close study due to AEs experienced by subjects in other studies.)
First Posted : March 26, 2010
Last Update Posted : March 13, 2013
Sponsor:
Information provided by:
Mayo Clinic

March 24, 2010
March 26, 2010
March 13, 2013
November 2010
December 2011   (Final data collection date for primary outcome measure)
Urine protein excretion [ Time Frame: one year ]
Urine protein excretion at 12 weeks of renin inhibition with aliskiren
Same as current
Complete list of historical versions of study NCT01093781 on ClinicalTrials.gov Archive Site
Blood pressure control; tolerability and side effects [ Time Frame: one year ]
Blood pressure control; tolerabillity and side effects [ Time Frame: one year ]
Not Provided
Not Provided
 
Aliskiren in Patients With Idiopathic Membranous Nephropathy
A Pilot Study to Evaluate the Antiproteinuric Effect of Renin Inhibition With Aliskiren in Patients With Idiopathic Membranous Nephropathy
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).

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Idiopathic Membranous Nephropathy
Drug: Aliskiren
Aliskiren dose will begin with 150mg per day and later up-titrated to the maximum available dose of 300mg per day.
Other Name: Tekturna
Experimental: Aliskiren
Aliskiren dose will begin with 150mg per day and later up-titrated to the maximum available dose of 300mg per day.
Intervention: Drug: Aliskiren
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
10
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01093781
09-007837
Yes
Not Provided
Not Provided
Fernando Fervenza, MD, PhD, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Fernando Fervenza, MD, PhD Mayo Clinic
Mayo Clinic
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP