Study of WAL0921 in Patients With Glomerular Kidney Diseases

Last updated: March 23, 2026
Sponsor: Walden Biosciences
Overall Status: Active - Recruiting

Phase

2

Condition

Kidney Disease

Idiopathic Membranous Nephropathy

Nephrotic Syndrome

Treatment

WAL0921

Placebo

Clinical Study ID

NCT06466135
WAL0921-02
  • Ages 18-75
  • All Genders

Study 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

Inclusion

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 changedisease; primary IgA nephropathy; primary membranous nephropathy

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

Exclusion

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 studyrequirements

Study Design

Total Participants: 96
Treatment Group(s): 2
Primary Treatment: WAL0921
Phase: 2
Study Start date:
July 02, 2024
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Western Health Sunshine Hospital

    St Albans, Victoria 3021
    Australia

    Site Not Available

  • AIIMS Hospital

    Raipur, Chhattisgarh 492099
    India

    Active - Recruiting

  • Muljibhai Patel Urological Hospital

    Nadiād, Gujarat 387003
    India

    Active - Recruiting

  • Dhiraj Hospital

    Vadodara, Gujarat 391760
    India

    Active - Recruiting

  • MS Ramaiah Medical College and Hospitals

    Bangalore, Karnataka 560054
    India

    Active - Recruiting

  • Mazumdar Shah Medical Center

    Bangalore, Karnataka 560099
    India

    Active - Recruiting

  • Manipal Hospital

    Pune, Maharashtra 411045
    India

    Active - Recruiting

  • MGM Medical Care and Hospital

    Sambhajinagar, Maharashtra 431003
    India

    Active - Recruiting

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi 110060
    India

    Active - Recruiting

  • Max Super Speciality Hospital

    Patparganj, National Capital Territory of Delhi 110092
    India

    Active - Recruiting

  • SUM Hospital

    Bhubaneswar, Odisha 751029
    India

    Active - Recruiting

  • SMS Medical College and Hospital

    Jaipur, Rajasthan 302004
    India

    Active - Recruiting

  • Nizam's Institute of Medical Sciences

    Hyderabad, Telangana 500082
    India

    Active - Recruiting

  • Osmania General Hospital

    Hyderabad, Telangana 500012
    India

    Active - Recruiting

  • Sanjay Gandhi Post Graduate Institute of Medical Sciences

    Lucknow, Uttar Pradesh 226014
    India

    Active - Recruiting

  • Nutema Hospital

    Meerut, Uttar Pradesh 250002
    India

    Active - Recruiting

  • Shri Guru Ram Rai Institute of Medical and Health Sciences

    Dehradun, Uttarakhand 248001
    India

    Active - Recruiting

  • NRS Medical College and Hospital Kolkata

    Kolkata, West Bengal 700014
    India

    Active - Recruiting

  • Hospital Canselor Tuanku Muhriz UKM

    Cheras, Kuala Lumpur 56000
    Malaysia

    Active - Recruiting

  • Hospital Kuala Lumpur

    Kuala Lumpur, Kuala Lumpur 50586
    Malaysia

    Active - Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur 50603
    Malaysia

    Active - Recruiting

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang 25100
    Malaysia

    Active - Recruiting

  • Hospital Sultan Idris Shah Serdang

    Kajang, Selangor 43000
    Malaysia

    Active - Recruiting

  • Sunway Medical Centre

    Petaling Jaya, Selangor 47500
    Malaysia

    Active - Recruiting

  • Hallym University Sacred Heart Hospital

    Anyang, 14068
    South Korea

    Active - Recruiting

  • Pusan National University Hospital

    Busan, 49241
    South Korea

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620
    South Korea

    Active - Recruiting

  • Severance Hospital - Yonsei Cancer Center

    Seoul, 03722
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Soeul, 06351
    South Korea

    Active - Recruiting

  • Ajou University Hospital

    Suwon, 16499
    South Korea

    Active - Recruiting

  • National Hospital of Sri Lanka

    Colombo, 00700
    Sri Lanka

    Site Not Available

  • Jaffna Teaching Hospital

    Jaffna, 40000
    Sri Lanka

    Site Not Available

  • Kandy National Hospital

    Kandy, 20000
    Sri Lanka

    Site Not Available

  • Kurunegala Teaching Hospital

    Kurunegala, 60000
    Sri Lanka

    Site Not Available

  • Kothalawala Defence University Hospital

    Werahera, 10290
    Sri Lanka

    Site Not Available

  • Royal Derby Hospital

    Derby, DE22 3NE
    United Kingdom

    Site Not Available

  • College of Life Sciences, University of Leicester

    Leicester, LE1 7RH
    United Kingdom

    Site Not Available

  • Barts Health NHS Trust

    London, E1 2ES
    United Kingdom

    Site Not Available

  • Manchester University NHS Foundation Trust

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Salford Royal NHS Foundation Trust

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Academic Medical Research Institute

    Los Angeles, California 90022
    United States

    Active - Recruiting

  • Colorado Kidney and Vascular Care

    Denver, Colorado 80012
    United States

    Active - Recruiting

  • D & H Tamarac Research Center

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • Fides Clinical Research

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Nephrology Associates of Northern Illinois and Indiana (NANI)

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Dunes Clinical Research

    Dakota Dunes, South Dakota 57049
    United States

    Active - Recruiting

  • Clinical Trial Network

    Houston, Texas 77074
    United States

    Active - Recruiting

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Active - Recruiting

  • Clinical Advancement Center

    San Antonio, Texas 78212
    United States

    Active - Recruiting

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