Status:
COMPLETED
Rituximab in Membranous Nephropathy
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Membranous Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Membranous glomerulopathy (MN) is a common immune-mediated glomerular disease and the leading cause of nephrotic syndrome in Caucasian adults. 1 Because of its frequency, it remains the second or thir...
Detailed Description
There is convincing evidence from both experimental and human studies that MN is mediated by the deposition of IgG antibodies in the subepithelial aspect of the GBM. More debatable, is the mechanism(s...
Eligibility Criteria
Inclusion
- Patients must meet the following inclusion criteria to be eligible for study entry:
- Membranous Nephropathy with diagnostic biopsy performed within the last 3 years. Renal biopsy slides and electron photomicrographs will be reviewed by study investigators, and must confirm a diagnosis of MN.
- Age \ 18 years.
- Proteinuria as measured via Uprot/UCr ratio \> 4.0 on a spot sample of a 24-hour urine collection, despite ACE inhibitor / ARB treatment. The choice of urine protein/creatinine ratios is in accord with recently developed National Kidney Foundation Chronic Kidney Disease (NKF-CKD) guidelines.107 The NKF-CKD guidelines advocate urine protein/creatinine ratios as the preferred method for evaluation of urinary protein excretion in both adults and children.
- Patients need to be treated with an ACEI and/or ARB, for at least 3 months prior to enrollment with adequately controlled blood pressure (BP \<140/80 mm Hg in \>75% of the readings).
- Women must be post-menopausal, surgically sterile or practicing a medically approved method of contraception.
- Patients with thromboembolic complications and/or clinical signs of NS that are not controlled with conventional medical treatment will enter the immunosuppressive portion of the protocol (Rituxan treatment) without the 3 months of ACE/ARB treatment (high risk patients).
- Able and willing to give written informed consent and comply with the requirements of the study protocol
- Adequate renal function as indicated by estimated GFR \≥ 25 ml/min per 1.73m2 and/or or serum creatinine \<4.0 mg/dL in the presence of ACE inhibitor/ARB therapy. The GFR will be estimated using the 4 variable MDRD equation as published in the NKF-CKD guidelines. The same NKF-CKD guidelines also promote the use of estimated GFR (GFRest) values rather than serum creatinine levels or creatinine clearance measurements as the preferred non-invasive method of determining glomerular filtration rates.107 We have opted to use this approach rather than the much more expensive and more invasive techniques that employ clearance measurements of exogenous substances (such as inulin or iothalamate) since the likelihood of detecting significant changes in GFR in this short term study is remote - no matter which method is chosen. The inclusion of and/or serum creatinine \<4.0 mg/dL is to cover possibility of incomplete 24-hour collection at time baseline creatinine clearance.)
- Adequate liver function, as indicated by bilirubin, AST, and alkaline phosphatase levels (up to \< 2.5 times the upper normal limit).
- Negative serum pregnancy test (for women of child bearing age)
- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment or a period of 21 months for those undergoing retreatment.
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00425217
Start Date
August 1 2004
End Date
April 1 2007
Last Update
February 25 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905