Status:
COMPLETED
Rituximab in the Treatment of Idiopathic Membranous Nephropathy
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Membranous Nephropathy
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Membranous glomerulopathy (MN) is still the most common glomerular disease associated with nephrotic proteinuria (NS). Up to 40% of patients reach end stage renal failure (ESRD), making MN the 2nd or ...
Detailed Description
a. Study Overview: Once a patient with idiopathic MN and proteinuria \>5g/24h is identified and meets other entry criteria, he/she will receive a minimum of 4 months of non-immunosuppressive therapy a...
Eligibility Criteria
Inclusion
- Idiopathic MN with diagnostic biopsy performed within the past 24 months.
- Age \> 18 years
- If female, must be post-menopausal, surgically sterile or practicing a medically approved method of contraception
- Patients need to be treated with an ACEI and/or ARB, for at least 4 months prior to rituximab treatment and have adequately controlled blood pressure (BP \<130/75 mm Hg in \>75% of the readings).
- Proteinuria as measured by urinary proteinuria / urinary creatinine \> 5.0 on a spot sample aliquot from a 24-hour urine collection.
- Estimated GFR \≥ 30 ml/min/1.73m2 while taking ACEI/ARB therapy.
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00405340
Start Date
October 1 2006
End Date
April 1 2012
Last Update
October 27 2015
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905