Status:
COMPLETED
Eculizumab Therapy for Dense Deposit Disease and C3 Nephropathy
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Alexion Pharmaceuticals, Inc.
Conditions:
Dense Deposit Disease
Membranoproliferative Glomerulonephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This open label, non-blinded, proof of concept efficacy and safety study of eculizumab in patients with biopsy proven DDD or C3 nephropathy. The trial will consist of adult patients with these disease...
Detailed Description
Dense deposit disease (DDD), also called membranoproliferative glomerulonephritis (MPGN) type II, is a rare form of glomerulonephritis named because of the characteristic appearance of electron-dense ...
Eligibility Criteria
Inclusion
- Adult patients with biopsy proven DDD or C3 nephropathy, at least 18 years of age
- 24-hour urine protein \> 1000 mg/day, urine protein:creatinine ratio \> 1.0, or acute renal failure (defined as \> 50% increase in serum creatinine from baseline)
- Willing and able to sign informed consent
- Patients of childbearing age must agree to use birth control
- Patients must be willing to be vaccinated against meningococcal disease or have documentation of previous vaccination against meningococcal disease
Exclusion
- Patients under 18 years of age
- Patients unable to sign informed consent
- Patients having received rituximab or another monoclonal antibody within 6 months of the trial
- Patients currently taking and unable to discontinue other immunomodulatory therapies (e.g. cyclosporine, high-dose steroids, mycophenolate mofetil) unless these other therapies are indicated for prophylaxis of transplant rejection (e.g. stable doses of mycophenolate mofetil and/or calcineurin inhibitor). Patients on chronic steroid therapy who are unable to taper down to \<10 mg/day will be excluded.
- Patients of childbearing age who refuse to use birth control
- Patients with a baseline estimated GFR less than 30 ml/min/1.73m2
- Patients with other renal diseases (e.g. diabetic nephropathy, renal vascular disease) that would interfere with interpretation of the study.
- Patients with comorbid conditions that would interfere with completion of the trial (malignancies, congestive heart failure (CHF), recent myocardial infarction).
- Patients with known contraindications to the use of eculizumab, including refusal to receive N. meningitides vaccine prior to therapy
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01221181
Start Date
July 1 2010
End Date
October 1 2011
Last Update
February 19 2019
Active Locations (2)
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1
Columbia University Medical Center, Glomerular Center
New York, New York, United States, 10032
2
Columbia University Medical Center, Nephrology Clinical Research Center
New York, New York, United States, 10032