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NCT06466135PHASE2Recruiting

Study of WAL0921 in Patients With Glomerular Kidney Diseases

Walden Biosciences

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

Inclusion Criteria: * 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 Exclusion Criteria: * 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 of Screening * Any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements

Interventions

DRUG

WAL0921

DRUG

Placebo

Interested in This Trial?

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Conditions

Diabetic NephropathiesPrimary Focal Segmental GlomerulosclerosisMinimal Change DiseasePrimary Immunoglobulin A NephropathyPrimary Membranous Nephropathy

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