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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WAL0921 | Experimental | Intravenous infusion of investigational drug WAL0921 |
|
| Placebo | Placebo Comparator | Intravenous infusion of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WAL0921 | Drug | Investigational drug WAL0921 Participants receive an intravenous infusion of WAL0921 investigational drug once every 2 weeks for 7 total infusions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events | Baseline to Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in albuminuria | Percent change in urine albumin-creatinine ratio (UACR) | Baseline up to Week 24 |
| Change in proteinuria | Percent change in urine protein-creatinine ratio (UPCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle Skupien | Contact | 8573141961 | clinicaltrials@waldenbiosciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Blair, MD | Walden Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Research Institute | Recruiting | Los Angeles | California | 90022 | United States | |
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| Placebo | Drug | Placebo product Participants receive an intravenous infusion of placebo once every 2 weeks for 7 total infusions. |
|
| Baseline up to Week 24 |
| Change in estimated glomerular filtration rate | Percent change in estimated glomerular filtration rate (eGFR) | Baseline up to Week 24 |
| Change in rate of change in eGFR | Slope of eGFR | Baseline up to Week 24 |
| Colorado Kidney and Vascular Care |
| Recruiting |
| Denver |
| Colorado |
| 80012 |
| United States |
| D & H Tamarac Research Center | Recruiting | Tamarac | Florida | 33321 | United States |
| Fides Clinical Research | Recruiting | Atlanta | Georgia | 30342 | United States |
| Nephrology Associates of Northern Illinois and Indiana (NANI) | Recruiting | Hinsdale | Illinois | 60521 | United States |
| Dunes Clinical Research | Recruiting | Dakota Dunes | South Dakota | 57049 | United States |
| Prolato Clinical Research Center | Recruiting | Houston | Texas | 77054 | United States |
| Clinical Trial Network | Recruiting | Houston | Texas | 77074 | United States |
| Clinical Advancement Center | Recruiting | San Antonio | Texas | 78212 | United States |
| Westmead Hospital | Recruiting | Westmead | New South Wales | 2145 | Australia |
|
| Western Health Sunshine Hospital | Recruiting | St Albans | Victoria | 3021 | Australia |
|
| AIIMS Hospital | Recruiting | Raipur | Chhattisgarh | 492099 | India |
| Muljibhai Patel Urological Hospital | Recruiting | Nadiād | Gujarat | 387003 | India |
| Dhiraj Hospital | Recruiting | Vadodara | Gujarat | 391760 | India |
| MS Ramaiah Medical College and Hospitals | Recruiting | Bangalore | Karnataka | 560054 | India |
| Mazumdar Shah Medical Center | Recruiting | Bangalore | Karnataka | 560099 | India |
| Manipal Hospital | Recruiting | Pune | Maharashtra | 411045 | India |
| MGM Medical Care and Hospital | Recruiting | Sambhajinagar | Maharashtra | 431003 | India |
| Sir Ganga Ram Hospital | Recruiting | New Delhi | National Capital Territory of Delhi | 110060 | India |
| Max Super Speciality Hospital | Recruiting | Patparganj | National Capital Territory of Delhi | 110092 | India |
| SUM Hospital | Recruiting | Bhubaneswar | Odisha | 751029 | India |
| SMS Medical College and Hospital | Recruiting | Jaipur | Rajasthan | 302004 | India |
| Osmania General Hospital | Recruiting | Hyderabad | Telangana | 500012 | India |
| Nizam's Institute of Medical Sciences | Recruiting | Hyderabad | Telangana | 500082 | India |
| Sanjay Gandhi Post Graduate Institute of Medical Sciences | Recruiting | Lucknow | Uttar Pradesh | 226014 | India |
| Nutema Hospital | Recruiting | Meerut | Uttar Pradesh | 250002 | India |
| Shri Guru Ram Rai Institute of Medical and Health Sciences | Recruiting | Dehradun | Uttarakhand | 248001 | India |
| NRS Medical College and Hospital Kolkata | Recruiting | Kolkata | West Bengal | 700014 | India |
| Hospital Canselor Tuanku Muhriz UKM | Recruiting | Cheras | Kuala Lumpur | 56000 | Malaysia |
| Hospital Kuala Lumpur | Recruiting | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| University Malaya Medical Centre | Recruiting | Kuala Lumpur | Kuala Lumpur | 50603 | Malaysia |
| Hospital Tengku Ampuan Afzan | Recruiting | Kuantan | Pahang | 25100 | Malaysia |
| Hospital Sultan Idris Shah Serdang | Recruiting | Kajang | Selangor | 43000 | Malaysia |
| Sunway Medical Centre | Recruiting | Petaling Jaya | Selangor | 47500 | Malaysia |
| Hallym University Sacred Heart Hospital | Recruiting | Anyang | 14068 | South Korea |
| Pusan National University Hospital | Recruiting | Busan | 49241 | South Korea |
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | 13620 | South Korea |
| Severance Hospital - Yonsei Cancer Center | Recruiting | Seoul | 03722 | South Korea |
| Samsung Medical Center | Recruiting | Soeul | 06351 | South Korea |
| Ajou University Hospital | Recruiting | Suwon | 16499 | South Korea |
| National Hospital of Sri Lanka | Not yet recruiting | Colombo | 00700 | Sri Lanka |
| Jaffna Teaching Hospital | Not yet recruiting | Jaffna | 40000 | Sri Lanka |
| Kandy National Hospital | Not yet recruiting | Kandy | 20000 | Sri Lanka |
| Kurunegala Teaching Hospital | Not yet recruiting | Kurunegala | 60000 | Sri Lanka |
| Kothalawala Defence University Hospital | Not yet recruiting | Werahera | 10290 | Sri Lanka |
| Royal Derby Hospital | Not yet recruiting | Derby | DE22 3NE | United Kingdom |
|
| College of Life Sciences, University of Leicester | Not yet recruiting | Leicester | LE1 7RH | United Kingdom |
|
| Barts Health NHS Trust | Not yet recruiting | London | E1 2ES | United Kingdom |
|
| Manchester University NHS Foundation Trust | Not yet recruiting | Manchester | M13 9WL | United Kingdom |
|
| Salford Royal NHS Foundation Trust | Not yet recruiting | Salford | M6 8HD | United Kingdom |
|
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D009402 | Nephrosis, Lipoid |
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D009401 | Nephrosis |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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