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Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria

Status: Recruiting
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Adults, age 18-75 years

• Diagnosis of one of the following glomerular kidney diseases: diabetic nephropathy; primary focal segmental glomerulosclerosis; treatment resistant-minimal change disease; primary IgA nephropathy; primary membranous nephropathy

• eGFR greater than or equal to 30 mL/min/1.73 m2

Locations
United States
California
Academic Medical Research Institute
RECRUITING
Los Angeles
Colorado
Colorado Kidney and Vascular Care
RECRUITING
Denver
Florida
D & H Tamarac Research Center
RECRUITING
Tamarac
Georgia
Fides Clinical Research
RECRUITING
Atlanta
Illinois
Nephrology Associates of Northern Illinois and Indiana (NANI)
RECRUITING
Hinsdale
South Dakota
Dunes Clinical Research
RECRUITING
Dakota Dunes
Texas
Clinical Trial Network
RECRUITING
Houston
Prolato Clinical Research Center
RECRUITING
Houston
Clinical Advancement Center
RECRUITING
San Antonio
Other Locations
Australia
Western Health Sunshine Hospital
RECRUITING
St Albans
Westmead Hospital
RECRUITING
Westmead
India
Mazumdar Shah Medical Center
RECRUITING
Bangalore
MS Ramaiah Medical College and Hospitals
RECRUITING
Bangalore
SUM Hospital
RECRUITING
Bhubaneswar
Shri Guru Ram Rai Institute of Medical and Health Sciences
RECRUITING
Dehradun
Nizam's Institute of Medical Sciences
RECRUITING
Hyderabad
Osmania General Hospital
RECRUITING
Hyderabad
SMS Medical College and Hospital
RECRUITING
Jaipur
NRS Medical College and Hospital Kolkata
RECRUITING
Kolkata
Sanjay Gandhi Post Graduate Institute of Medical Sciences
RECRUITING
Lucknow
Nutema Hospital
RECRUITING
Meerut
Muljibhai Patel Urological Hospital
RECRUITING
Nadiād
Sir Ganga Ram Hospital
RECRUITING
New Delhi
Max Super Speciality Hospital
RECRUITING
Patparganj
Manipal Hospital
RECRUITING
Pune
AIIMS Hospital
RECRUITING
Raipur
MGM Medical Care and Hospital
RECRUITING
Sambhajinagar
Dhiraj Hospital
RECRUITING
Vadodara
Malaysia
Hospital Canselor Tuanku Muhriz UKM
RECRUITING
Cheras
Hospital Sultan Idris Shah Serdang
RECRUITING
Kajang
Hospital Kuala Lumpur
RECRUITING
Kuala Lumpur
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Hospital Tengku Ampuan Afzan
RECRUITING
Kuantan
Sunway Medical Centre
RECRUITING
Petaling Jaya
Republic of Korea
Hallym University Sacred Heart Hospital
RECRUITING
Anyang
Pusan National University Hospital
RECRUITING
Busan
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Severance Hospital - Yonsei Cancer Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Soeul
Ajou University Hospital
RECRUITING
Suwon
Sri Lanka
National Hospital of Sri Lanka
NOT_YET_RECRUITING
Colombo
Jaffna Teaching Hospital
NOT_YET_RECRUITING
Jaffna
Kandy National Hospital
NOT_YET_RECRUITING
Kandy
Kurunegala Teaching Hospital
NOT_YET_RECRUITING
Kurunegala
Kothalawala Defence University Hospital
NOT_YET_RECRUITING
Werahera
United Kingdom
Royal Derby Hospital
NOT_YET_RECRUITING
Derby
College of Life Sciences, University of Leicester
NOT_YET_RECRUITING
Leicester
Barts Health NHS Trust
NOT_YET_RECRUITING
London
Manchester University NHS Foundation Trust
NOT_YET_RECRUITING
Manchester
Salford Royal NHS Foundation Trust
NOT_YET_RECRUITING
Salford
Contact Information
Primary
Michelle Skupien
clinicaltrials@waldenbiosciences.com
8573141961
Time Frame
Start Date: 2024-07-02
Estimated Completion Date: 2027-06
Participants
Target number of participants: 96
Treatments
Experimental: WAL0921
Intravenous infusion of investigational drug WAL0921
Placebo_comparator: Placebo
Intravenous infusion of normal saline
Sponsors
Leads: Walden Biosciences

This content was sourced from clinicaltrials.gov

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