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Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria
Led by Walden Biosciences · Updated on 2026-04-02
96
Participants Needed
50
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, effects, and how the body processes the investigational drug WAL0921 in adults with glomerular kidney diseases that cause proteinuria. These diseases include diabetic nephropathy, primary focal segmental glomerulosclerosis, treatment-resistant minimal change disease, primary immunoglobulin A nephropathy, and primary membranous nephropathy. This is a phase 2, multi-center, randomized, double-blind, placebo-controlled trial. Participants will be randomly assigned to receive either WAL0921 or a placebo through an intravenous infusion every two weeks, for a total of seven infusions. The study compares these two groups to assess the drug's safety and impact. After completing the infusions, all participants will be monitored for an additional 24 weeks. During the study, researchers will track adverse events from the start through week 36 to evaluate safety. They will also measure changes in albuminuria, proteinuria, and kidney function (including estimated glomerular filtration rate) from baseline up to week 24. Follow-up visits and monitoring ensure participants' health and collect data on how the drug affects their kidney disease over time.
CONDITIONS
Brief Title
Study of WAL0921 in Patients With Glomerular Kidney Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with one of these glomerular kidney diseases: diabetic nephropathy; primary focal segmental glomerulosclerosis; treatment-resistant minimal change disease; primary immunoglobulin A nephropathy; primary membranous nephropathy
- Estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m2 or higher
You will not qualify if you...
- Currently pregnant or planning to become pregnant
- History of organ transplantation
- History of alcohol or substance use disorder
- Acute dialysis or acute kidney injury within 6 months before screening
- Any medical condition that the investigator believes would prevent safe participation or completion of the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 12 weeks
Participants receive an intravenous infusion of the investigational drug or placebo once every 2 weeks for a total of 7 infusions.
7 visits (in-person) every 2 weeks
Trial Site Locations
Total: 50 locations
1
Academic Medical Research Institute
Los Angeles, California, United States, 90022
Actively Recruiting
2
Colorado Kidney and Vascular Care
Denver, Colorado, United States, 80012
Actively Recruiting
3
D & H Tamarac Research Center
Tamarac, Florida, United States, 33321
Actively Recruiting
4
Fides Clinical Research
Atlanta, Georgia, United States, 30342
Actively Recruiting
5
Nephrology Associates of Northern Illinois and Indiana (NANI)
Hinsdale, Illinois, United States, 60521
Actively Recruiting
6
Dunes Clinical Research
Dakota Dunes, South Dakota, United States, 57049
Actively Recruiting
7
Prolato Clinical Research Center
Houston, Texas, United States, 77054
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8
Clinical Trial Network
Houston, Texas, United States, 77074
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9
Clinical Advancement Center
San Antonio, Texas, United States, 78212
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10
Westmead Hospital
Westmead, New South Wales, Australia, 2145
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11
Western Health Sunshine Hospital
St Albans, Victoria, Australia, 3021
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12
AIIMS Hospital
Raipur, Chhattisgarh, India, 492099
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13
Muljibhai Patel Urological Hospital
Nadiād, Gujarat, India, 387003
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14
Dhiraj Hospital
Vadodara, Gujarat, India, 391760
Actively Recruiting
15
MS Ramaiah Medical College and Hospitals
Bangalore, Karnataka, India, 560054
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16
Mazumdar Shah Medical Center
Bangalore, Karnataka, India, 560099
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17
Manipal Hospital
Pune, Maharashtra, India, 411045
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18
MGM Medical Care and Hospital
Sambhajinagar, Maharashtra, India, 431003
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19
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India, 110060
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20
Max Super Speciality Hospital
Patparganj, National Capital Territory of Delhi, India, 110092
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21
SUM Hospital
Bhubaneswar, Odisha, India, 751029
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22
SMS Medical College and Hospital
Jaipur, Rajasthan, India, 302004
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23
Osmania General Hospital
Hyderabad, Telangana, India, 500012
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24
Nizam's Institute of Medical Sciences
Hyderabad, Telangana, India, 500082
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25
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India, 226014
Actively Recruiting
26
Nutema Hospital
Meerut, Uttar Pradesh, India, 250002
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27
Shri Guru Ram Rai Institute of Medical and Health Sciences
Dehradun, Uttarakhand, India, 248001
Actively Recruiting
28
NRS Medical College and Hospital Kolkata
Kolkata, West Bengal, India, 700014
Actively Recruiting
29
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, Malaysia, 56000
Actively Recruiting
30
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
Actively Recruiting
31
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
Actively Recruiting
32
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia, 25100
Actively Recruiting
33
Hospital Sultan Idris Shah Serdang
Kajang, Selangor, Malaysia, 43000
Actively Recruiting
34
Sunway Medical Centre
Petaling Jaya, Selangor, Malaysia, 47500
Actively Recruiting
35
Hallym University Sacred Heart Hospital
Anyang, South Korea, 14068
Actively Recruiting
36
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
37
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
38
Severance Hospital - Yonsei Cancer Center
Seoul, South Korea, 03722
Actively Recruiting
39
Samsung Medical Center
Soeul, South Korea, 06351
Actively Recruiting
40
Ajou University Hospital
Suwon, South Korea, 16499
Actively Recruiting
41
National Hospital of Sri Lanka
Colombo, Sri Lanka, 00700
Not Yet Recruiting
42
Jaffna Teaching Hospital
Jaffna, Sri Lanka, 40000
Not Yet Recruiting
43
Kandy National Hospital
Kandy, Sri Lanka, 20000
Not Yet Recruiting
44
Kurunegala Teaching Hospital
Kurunegala, Sri Lanka, 60000
Not Yet Recruiting
45
Kothalawala Defence University Hospital
Werahera, Sri Lanka, 10290
Not Yet Recruiting
46
Royal Derby Hospital
Derby, United Kingdom, DE22 3NE
Not Yet Recruiting
47
College of Life Sciences, University of Leicester
Leicester, United Kingdom, LE1 7RH
Not Yet Recruiting
48
Barts Health NHS Trust
London, United Kingdom, E1 2ES
Not Yet Recruiting
49
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Not Yet Recruiting
50
Salford Royal NHS Foundation Trust
Salford, United Kingdom, M6 8HD
Not Yet Recruiting
Research Team
M
Michelle Skupien
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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