Phase
Condition
Glomerulonephritis
Nephrotic Syndrome
Idiopathic Membranous Nephropathy
Treatment
Rituximab
SNP-ACTH (1-39) Gel
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Biopsy-proven membranous glomerulonephritis or a diagnosis of MN in patients withNephrotic Syndrome and a positive anti PLA2R antibody test.
- Patients classified to be at a High Risk for progressive loss of kidney function, asdefined by Kidney Disease Improving Global Outcomes (KDIGO) 2021-Glomerular DiseasesGuideline.
- eGFR by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40mL/min/1.73 m^2
- Patients who have had CR or PR in response to immunosuppressive therapy, but thenrelapsed can participate in the study if it has been more than 3 months since theirlast dose of high dose glucocorticoids, calcineurin inhibitors or mycophenolatemofetil
- Patients who have had CR or PR in response to IS therapy, but then relapsed canparticipate in the study if it has been more than 6 months since their last dose ofchlorambucil or cyclophosphamide
- Patients who have had CR or PR in response to immunosuppressive therapy, but thenrelapsed can participate in the study if it has been more than 12 months since theirlast dose of rituximab.
- Life expectancy > 24 months.
- Other inclusion criteria may apply.
Exclusion
Exclusion Criteria:
- Secondary membranous nephropathy as defined by history, physical exam, kidney biopsyresults or serologies.
- Patients who have had a ≥ 50% reduction in serum titers of PLA2R auto-antibody within 1 year before screening.
- Type 1 or 2 diabetes mellitus
- Patients who must be initiated on drugs likely to affect renal function if notproperly dosed.
- Surgery within 1 month of study entry
- History of sensitivity to proteins of porcine origin.
- Other exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Regional Kidney Wellness Centre
Brampton, Ontario L6T 0H9
CanadaActive - Recruiting
Vedanta Hospitals
Guntur, Andhra Pradesh 522001
IndiaActive - Recruiting
Vijaya Super Speciality Hospital
Nellore, Andhra Pradesh 524001
IndiaActive - Recruiting
AIIMS
Raipur, Chhattisgarh 492099
IndiaActive - Recruiting
Sir Ganga Ram Hospital
New Delhi, Delhi 10060
IndiaActive - Recruiting
Muljibhai Patel Urological Hospital
Nadiād, Gujarat
IndiaActive - Recruiting
KLE Hospital
Belgaum, Karnataka 590010
IndiaActive - Recruiting
Saraswati Kidney Care Center
Nagpur, Maharashtra 440015
IndiaActive - Recruiting
PGIMER
Chandigarh, Punjab 160012
IndiaActive - Recruiting
Apex Hospitals
Jaipur, Rajasthan 302017
IndiaActive - Recruiting
SMS Medical College and Hospital
Jaipur, Rajasthan 302004
IndiaActive - Recruiting
Galaxy Hospital
Varanasi, Uttar Pradesh 221010
IndiaActive - Recruiting
Academic Medical Research Institute
Los Angeles, California 90022
United StatesActive - Recruiting
North America Research Institute
San Dimas, California 91773
United StatesActive - Recruiting
Valiance Clinical Research
Tarzana, California 91356
United StatesActive - Recruiting
Cerium Clinical Site
Boca Raton, Florida 33431
United StatesSite Not Available
RecioMed Clinical Research Network, Inc.
Boynton Beach, Florida 33472
United StatesActive - Recruiting
South Florida Nephrology Research
Coral Springs, Florida 33071
United StatesActive - Recruiting
Therafirst Medical Center
Fort Lauderdale, Florida 33308
United StatesActive - Recruiting
Reliant Medical Research, LLC
Miami, Florida 33165
United StatesActive - Recruiting
Vista Health Research, LLC
Miami, Florida 33176
United StatesActive - Recruiting
Genesis Clinical Research
Tampa, Florida 33603
United StatesActive - Recruiting
Fides Clinical Research
Atlanta, Georgia 30342
United StatesActive - Recruiting
Costal Medical Research
Brunswick, Georgia 31520
United StatesActive - Recruiting
Insight Hospital and Medical Center Chicago
Chicago, Illinois 60615
United StatesActive - Recruiting
University of Iowa
Iowa City, Iowa 52242
United StatesActive - Recruiting
Center for Advanced Kidney Research, PLC
Saint Clair Shores, Michigan 48080
United StatesActive - Recruiting
Cerium Clinical Site
Saint Clair Shores, Michigan 48080
United StatesActive - Recruiting
Cerium Clinical Site
New York, New York 10016
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
Prolato Clinical Research Center
Houston, Texas 77054
United StatesActive - Recruiting
P&I Clinical Research LLC
Lufkin, Texas 75904
United StatesActive - Recruiting
University of Virginia
Charlottesville, Virginia 22908
United StatesActive - Recruiting
Nephrology Associates of Northern Virginia
Fairfax, Virginia 22033
United StatesActive - Recruiting
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