Study of WAL0921 in Patients With Glomerular Kidney Diseases
Start Date
7/2/2024
Completion Date
6/1/2027
Summary
This is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and proteinuria, including diabetic nephropathy and rare glomerular kidney diseases (primary focal segmental glomerulosclerosis \[FSGS\], treatment-resistant minimal change disease \[TR MCD\], primary immunoglobulin A nephropathy \[IgAN\], and primary membranous nephropathy \[PMN\]). Subjects in this study will be randomized to receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total infusions. All subjects will be followed for 24 weeks after their last infusion.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
WAL0921
Placebo
Conditions
Locations
Academic Medical Research Institute
Los Angeles, California 90022
United States
Colorado Kidney and Vascular Care
Denver, Colorado 80012
United States
D & H Tamarac Research Center
Tamarac, Florida 33321
United States
Fides Clinical Research
Atlanta, Georgia 30342
United States
Nephrology Associates of Northern Illinois and Indiana (NANI)
Hinsdale, Illinois 60521
United States
Dunes Clinical Research
Dakota Dunes, South Dakota 57049
United States
Prolato Clinical Research Center
Houston, Texas 77054
United States
Clinical Trial Network
Houston, Texas 77074
United States
Clinical Advancement Center
San Antonio, Texas 78212
United States
Westmead Hospital
Westmead, New South Wales 2145
Australia
Western Health Sunshine Hospital
St Albans, Victoria 3021
Australia
AIIMS Hospital
Raipur, Chhattisgarh 492099
India
Muljibhai Patel Urological Hospital
Nadiād, Gujarat 387003
India
Dhiraj Hospital
Vadodara, Gujarat 391760
India
MS Ramaiah Medical College and Hospitals
Bangalore, Karnataka 560054
India
Mazumdar Shah Medical Center
Bangalore, Karnataka 560099
India
Manipal Hospital
Pune, Maharashtra 411045
India
MGM Medical Care and Hospital
Sambhajinagar, Maharashtra 431003
India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi 110060
India
Max Super Speciality Hospital
Patparganj, National Capital Territory of Delhi 110092
India
SUM Hospital
Bhubaneswar, Odisha 751029
India
SMS Medical College and Hospital
Jaipur, Rajasthan 302004
India
Osmania General Hospital
Hyderabad, Telangana 500012
India
Nizam's Institute of Medical Sciences
Hyderabad, Telangana 500082
India
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, Uttar Pradesh 226014
India
Nutema Hospital
Meerut, Uttar Pradesh 250002
India
Shri Guru Ram Rai Institute of Medical and Health Sciences
Dehradun, Uttarakhand 248001
India
NRS Medical College and Hospital Kolkata
Kolkata, West Bengal 700014
India
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur 56000
Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur 50586
Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur 50603
Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang 25100
Malaysia
Hospital Sultan Idris Shah Serdang
Kajang, Selangor 43000
Malaysia
Sunway Medical Centre
Petaling Jaya, Selangor 47500
Malaysia
Hallym University Sacred Heart Hospital
Anyang, 14068
South Korea
Pusan National University Hospital
Busan, 49241
South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620
South Korea
Severance Hospital - Yonsei Cancer Center
Seoul, 03722
South Korea
Samsung Medical Center
Soeul, 06351
South Korea
Ajou University Hospital
Suwon, 16499
South Korea
National Hospital of Sri Lanka
Colombo, 00700
Sri Lanka
Jaffna Teaching Hospital
Jaffna, 40000
Sri Lanka
Kandy National Hospital
Kandy, 20000
Sri Lanka
Kurunegala Teaching Hospital
Kurunegala, 60000
Sri Lanka
Kothalawala Defence University Hospital
Werahera, 10290
Sri Lanka
Royal Derby Hospital
Derby, DE22 3NE
United Kingdom
College of Life Sciences, University of Leicester
Leicester, LE1 7RH
United Kingdom
Barts Health NHS Trust
London, E1 2ES
United Kingdom
Manchester University NHS Foundation Trust
Manchester, M13 9WL
United Kingdom
Salford Royal NHS Foundation Trust
Salford, M6 8HD
United Kingdom