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Study of WAL0921 in Patients With Glomerular Kidney Diseases
Sponsor: Walden Biosciences
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.
Official title: Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2024-07-02
Completion Date
2027-06
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
WAL0921
Investigational drug WAL0921 Participants receive an intravenous infusion of WAL0921 investigational drug once every 2 weeks for 7 total infusions.
Placebo
Placebo product Participants receive an intravenous infusion of placebo once every 2 weeks for 7 total infusions.
Locations (50)
Academic Medical Research Institute
Los Angeles, California, United States
Colorado Kidney and Vascular Care
Denver, Colorado, United States
D & H Tamarac Research Center
Tamarac, Florida, United States
Fides Clinical Research
Atlanta, Georgia, United States
Nephrology Associates of Northern Illinois and Indiana (NANI)
Hinsdale, Illinois, United States
Dunes Clinical Research
Dakota Dunes, South Dakota, United States
Prolato Clinical Research Center
Houston, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Clinical Advancement Center
San Antonio, Texas, United States
Westmead Hospital
Westmead, New South Wales, Australia
Western Health Sunshine Hospital
St Albans, Victoria, Australia
AIIMS Hospital
Raipur, Chhattisgarh, India
Muljibhai Patel Urological Hospital
Nadiād, Gujarat, India
Dhiraj Hospital
Vadodara, Gujarat, India
MS Ramaiah Medical College and Hospitals
Bangalore, Karnataka, India
Mazumdar Shah Medical Center
Bangalore, Karnataka, India
Manipal Hospital
Pune, Maharashtra, India
MGM Medical Care and Hospital
Sambhajinagar, Maharashtra, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
Max Super Speciality Hospital
Patparganj, National Capital Territory of Delhi, India
SUM Hospital
Bhubaneswar, Odisha, India
SMS Medical College and Hospital
Jaipur, Rajasthan, India
Osmania General Hospital
Hyderabad, Telangana, India
Nizam's Institute of Medical Sciences
Hyderabad, Telangana, India
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India
Nutema Hospital
Meerut, Uttar Pradesh, India
Shri Guru Ram Rai Institute of Medical and Health Sciences
Dehradun, Uttarakhand, India
NRS Medical College and Hospital Kolkata
Kolkata, West Bengal, India
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
Hospital Sultan Idris Shah Serdang
Kajang, Selangor, Malaysia
Sunway Medical Centre
Petaling Jaya, Selangor, Malaysia
Hallym University Sacred Heart Hospital
Anyang, South Korea
Pusan National University Hospital
Busan, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Severance Hospital - Yonsei Cancer Center
Seoul, South Korea
Samsung Medical Center
Soeul, South Korea
Ajou University Hospital
Suwon, South Korea
National Hospital of Sri Lanka
Colombo, Sri Lanka
Jaffna Teaching Hospital
Jaffna, Sri Lanka
Kandy National Hospital
Kandy, Sri Lanka
Kurunegala Teaching Hospital
Kurunegala, Sri Lanka
Kothalawala Defence University Hospital
Werahera, Sri Lanka
Royal Derby Hospital
Derby, United Kingdom
College of Life Sciences, University of Leicester
Leicester, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Salford Royal NHS Foundation Trust
Salford, United Kingdom