Aliskiren in Patients With Idiopathic Membranous Nephropathy

NCT01093781 | Withdrawn DMC

• 1 other identifier: 09-007837
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Idiopathic Membranous Nephropathy

Keywords

membranous nephropathy aliskiren proteinuria, glomerulonephritis

Outcome Measures

Primary Outcomes (1)

• Urine protein excretion

  Urine protein excretion at 12 weeks of renin inhibition with aliskiren

  one year

Secondary Outcomes (1)

• Blood pressure control; tolerability and side effects

  one year

Study Arms (1)

Aliskiren

EXPERIMENTAL

Aliskiren dose will begin with 150mg per day and later up-titrated to the maximum available dose of 300mg per day.

Drug: Aliskiren

Interventions

Aliskiren DRUG

Aliskiren dose will begin with 150mg per day and later up-titrated to the maximum available dose of 300mg per day.

Also known as: Tekturna

Aliskiren

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Glomerulonephritis, Membranous; Glomerulonephritis

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Fernando Fervenza, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 26, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 13, 2013

Record last verified: 2013-03

Locations

US (1)