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Aliskiren in Patients With Idiopathic Membranous Nephropathy

This study has been withdrawn prior to enrollment.
(Manufacturer asked to close study due to AEs experienced by subjects in other studies.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01093781
First received: March 24, 2010
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

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).


Condition Intervention
Idiopathic Membranous Nephropathy
 Drug: Aliskiren

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Antiproteinuric Effect of Renin Inhibition With Aliskiren in Patients With Idiopathic Membranous Nephropathy

Resource links provided by NLM:

Drug Information available for: Aliskiren
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Urine protein excretion [ Time Frame: one year ] [ Designated as safety issue: No ]
    Urine protein excretion at 12 weeks of renin inhibition with aliskiren


Secondary Outcome Measures:
  • Blood pressure control; tolerability and side effects [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren
Aliskiren dose will begin with 150mg per day and later up-titrated to the maximum available dose of 300mg per day.
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093781

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Fernando Fervenza, MD, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Fernando Fervenza, MD, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01093781     History of Changes
Other Study ID Numbers: 09-007837
Study First Received: March 24, 2010
Last Updated: March 12, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
membranous nephropathy aliskiren proteinuria, glomerulonephritis

Additional relevant MeSH terms:
Glomerulonephritis, Membranous
Kidney Diseases
Glomerulonephritis
Nephritis
 Urologic Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013