Study of WAL0921 in Patients With Glomerular Kidney Diseases

March 27, 2026 updated by: Walden Biosciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
    • Victoria
  • India
    • Chhattisgarh
      • Raipur, Chhattisgarh, India, 492099
        • Recruiting
        • AIIMS Hospital
    • Gujarat
      • Nadiād, Gujarat, India, 387003
        • Recruiting
        • Muljibhai Patel Urological Hospital
      • Vadodara, Gujarat, India, 391760
        • Recruiting
        • Dhiraj Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • Recruiting
        • MS Ramaiah Medical College and Hospitals
      • Bangalore, Karnataka, India, 560099
        • Recruiting
        • Mazumdar Shah Medical Center
    • Maharashtra
      • Pune, Maharashtra, India, 411045
        • Recruiting
        • Manipal Hospital
      • Sambhajinagar, Maharashtra, India, 431003
        • Recruiting
        • MGM Medical Care and Hospital
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110060
        • Recruiting
        • Sir Ganga Ram Hospital
      • Patparganj, National Capital Territory of Delhi, India, 110092
        • Recruiting
        • Max Super Speciality Hospital
    • Odisha
      • Bhubaneswar, Odisha, India, 751029
        • Recruiting
        • SUM Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • Recruiting
        • SMS Medical College and Hospital
    • Telangana
      • Hyderabad, Telangana, India, 500012
        • Recruiting
        • Osmania General Hospital
      • Hyderabad, Telangana, India, 500082
        • Recruiting
        • Nizam's Institute of Medical Sciences
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226014
        • Recruiting
        • Sanjay Gandhi Post Graduate Institute of Medical Sciences
      • Meerut, Uttar Pradesh, India, 250002
        • Recruiting
        • Nutema Hospital
    • Uttarakhand
      • Dehradun, Uttarakhand, India, 248001
        • Recruiting
        • Shri Guru Ram Rai Institute of Medical and Health Sciences
    • West Bengal
      • Kolkata, West Bengal, India, 700014
        • Recruiting
        • NRS Medical College and Hospital Kolkata
  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Recruiting
        • Hospital Canselor Tuanku Muhriz UKM
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
        • Recruiting
        • Hospital Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
        • Recruiting
        • University Malaya Medical Centre
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Recruiting
        • Hospital Tengku Ampuan Afzan
    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • Recruiting
        • Hospital Sultan Idris Shah Serdang
      • Petaling Jaya, Selangor, Malaysia, 47500
        • Recruiting
        • Sunway Medical Centre
  • South Korea
      • Anyang, South Korea, 14068
        • Recruiting
        • Hallym University Sacred Heart Hospital
      • Busan, South Korea, 49241
        • Recruiting
        • Pusan National University Hospital
      • Seongnam-si, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital - Yonsei Cancer Center
      • Soeul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Suwon, South Korea, 16499
        • Recruiting
        • Ajou University Hospital
  • Sri Lanka
      • Colombo, Sri Lanka, 00700
        • Not yet recruiting
        • National Hospital of Sri Lanka
      • Jaffna, Sri Lanka, 40000
        • Not yet recruiting
        • Jaffna Teaching Hospital
      • Kandy, Sri Lanka, 20000
        • Not yet recruiting
        • Kandy National Hospital
      • Kurunegala, Sri Lanka, 60000
        • Not yet recruiting
        • Kurunegala Teaching Hospital
      • Werahera, Sri Lanka, 10290
        • Not yet recruiting
        • Kothalawala Defence University Hospital
  • United Kingdom
      • Derby, United Kingdom, DE22 3NE
      • Leicester, United Kingdom, LE1 7RH
      • London, United Kingdom, E1 2ES
      • Manchester, United Kingdom, M13 9WL
      • Salford, United Kingdom, M6 8HD
  • United States
    • California
      • Los Angeles, California, United States, 90022
        • Recruiting
        • Academic Medical Research Institute
    • Colorado
      • Denver, Colorado, United States, 80012
        • Recruiting
        • Colorado Kidney and Vascular Care
    • Florida
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • D & H Tamarac Research Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Fides Clinical Research
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Recruiting
        • Nephrology Associates of Northern Illinois and Indiana (NANI)
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Recruiting
        • Dunes Clinical Research
    • Texas
      • Houston, Texas, United States, 77054
        • Recruiting
        • Prolato Clinical Research Center
      • Houston, Texas, United States, 77074
        • Recruiting
        • Clinical Trial Network
      • San Antonio, Texas, United States, 78212
        • Recruiting
        • Clinical Advancement Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WAL0921
Intravenous infusion of investigational drug WAL0921
Drug: WAL0921
Investigational drug WAL0921 Participants receive an intravenous infusion of WAL0921 investigational drug once every 2 weeks for 7 total infusions.
Placebo Comparator: Placebo
Intravenous infusion of normal saline
Drug: Placebo
Placebo product Participants receive an intravenous infusion of placebo once every 2 weeks for 7 total infusions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment emergent adverse events
Time Frame: Baseline to Week 36
Baseline to Week 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in albuminuria
Time Frame: Baseline up to Week 24
Percent change in urine albumin-creatinine ratio (UACR)
Baseline up to Week 24
Change in proteinuria
Time Frame: Baseline up to Week 24
Percent change in urine protein-creatinine ratio (UPCR)
Baseline up to Week 24
Change in estimated glomerular filtration rate
Time Frame: Baseline up to Week 24
Percent change in estimated glomerular filtration rate (eGFR)
Baseline up to Week 24
Change in rate of change in eGFR
Time Frame: Baseline up to Week 24
Slope of eGFR
Baseline up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walden Biosciences

Investigators

  • Study Director: Andrew Blair, MD, Walden Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WAL0921-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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