Clinical trial Recruiting at 25 sites Phase 2 Interventional Ages 18 to 75

Evaluating WAL0921 for kidney diseases

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

Run by Walden Biosciences · NCT06466135 · Data updated 2026-11-12

This study is testing a new drug called WAL0921 to see if it can help people with different types of kidney diseases feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment96 (estimated)
SponsorWalden Biosciences
Industry-sponsored
Locations50 sites (Los Angeles, California and 49 other locations)
StatusRecruiting
StartedJuly 2, 2024
Main results expectedMarch 2027
Study endsJune 2027
Registry record updatedAugust 3, 2026
Trial IDNCT06466135 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-75 with specific glomerular kidney diseases and an eGFR of 30 mL/min/1.73 m2 or higher.

Probably not a fit

Patients who are currently pregnant, have a history of organ transplantation, or have acute kidney injury within the last six months may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is an adaptive, multi-center, randomized, double-blind, placebo-controlled study aimed at assessing the safety and efficacy of WAL0921 in patients with various glomerular kidney diseases, including diabetic nephropathy and rare conditions like focal segmental glomerulosclerosis. Participants will receive either the investigational drug or a placebo via intravenous infusion every two weeks for a total of seven infusions. The study will monitor participants for 24 weeks following their last infusion to evaluate the drug's pharmacokinetics and pharmacodynamics.

Why it matters

Potential benefit: If successful, this treatment could significantly improve kidney function and reduce proteinuria in patients with glomerular kidney diseases.

How similar studies have gone: Other studies have shown promise in treating similar kidney conditions, but the specific approach with WAL0921 is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Academic Medical Research Institute
    Los Angeles, California, United States
    Recruiting
  • Colorado Kidney and Vascular Care
    Denver, Colorado, United States
    Recruiting
  • D & H Tamarac Research Center
    Tamarac, Florida, United States
    Recruiting
  • Fides Clinical Research
    Atlanta, Georgia, United States
    Recruiting
  • Nephrology Associates of Northern Illinois and Indiana (NANI)
    Hinsdale, Illinois, United States
    Recruiting
  • Dunes Clinical Research
    Dakota Dunes, South Dakota, United States
    Recruiting
Show 44 more locations
  • Prolato Clinical Research Center
    Houston, Texas, United States
    Recruiting
  • Clinical Trial Network
    Houston, Texas, United States
    Recruiting
  • Clinical Advancement Center
    San Antonio, Texas, United States
    Recruiting
  • Westmead Hospital
    Westmead, New South Wales, Australia
    Recruiting
  • Western Health Sunshine Hospital
    St Albans, Victoria, Australia
    Recruiting
  • Hospital Canselor Tuanku Muhriz UKM
    Cheras, Kuala Lumpur, Malaysia
    Recruiting
  • Hospital Kuala Lumpur
    Kuala Lumpur, Kuala Lumpur, Malaysia
    Recruiting
  • University Malaya Medical Centre
    Kuala Lumpur, Kuala Lumpur, Malaysia
    Recruiting
  • Hospital Tengku Ampuan Afzan
    Kuantan, Pahang, Malaysia
    Recruiting
  • Hospital Sultan Idris Shah Serdang
    Kajang, Selangor, Malaysia
    Recruiting
  • Sunway Medical Centre
    Petaling Jaya, Selangor, Malaysia
    Recruiting
  • Hallym University Sacred Heart Hospital
    Anyang, South Korea
    Recruiting
  • Pusan National University Hospital
    Busan, South Korea
    Recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, South Korea
    Recruiting
  • Severance Hospital - Yonsei Cancer Center
    Seoul, South Korea
    Recruiting
  • Samsung Medical Center
    Soeul, South Korea
    Recruiting
  • Ajou University Hospital
    Suwon, South Korea
    Recruiting
  • Royal Derby Hospital
    Derby, United Kingdom
    Recruiting
  • College of Life Sciences, University of Leicester
    Leicester, United Kingdom
    Recruiting
  • AIIMS Hospital
    Raipur, Chhattisgarh, India
    Active not recruiting
  • Muljibhai Patel Urological Hospital
    Nadiād, Gujarat, India
    Active not recruiting
  • Dhiraj Hospital
    Vadodara, Gujarat, India
    Active not recruiting
  • MS Ramaiah Medical College and Hospitals
    Bangalore, Karnataka, India
    Active not recruiting
  • Mazumdar Shah Medical Center
    Bangalore, Karnataka, India
    Active not recruiting
  • Manipal Hospital
    Pune, Maharashtra, India
    Active not recruiting
  • MGM Medical Care and Hospital
    Sambhajinagar, Maharashtra, India
    Active not recruiting
  • Sir Ganga Ram Hospital
    New Delhi, National Capital Territory of Delhi, India
    Active not recruiting
  • Max Super Speciality Hospital
    Patparganj, National Capital Territory of Delhi, India
    Active not recruiting
  • SUM Hospital
    Bhubaneswar, Odisha, India
    Active not recruiting
  • SMS Medical College and Hospital
    Jaipur, Rajasthan, India
    Active not recruiting
  • Osmania General Hospital
    Hyderabad, Telangana, India
    Active not recruiting
  • Nizam's Institute of Medical Sciences
    Hyderabad, Telangana, India
    Active not recruiting
  • Sanjay Gandhi Post Graduate Institute of Medical Sciences
    Lucknow, Uttar Pradesh, India
    Active not recruiting
  • Nutema Hospital
    Meerut, Uttar Pradesh, India
    Active not recruiting
  • Shri Guru Ram Rai Institute of Medical and Health Sciences
    Dehradun, Uttarakhand, India
    Active not recruiting
  • NRS Medical College and Hospital Kolkata
    Kolkata, West Bengal, India
    Active not recruiting
  • National Hospital of Sri Lanka
    Colombo, Sri Lanka
    Not yet recruiting
  • Jaffna Teaching Hospital
    Jaffna, Sri Lanka
    Not yet recruiting
  • Kandy National Hospital
    Kandy, Sri Lanka
    Not yet recruiting
  • Kurunegala Teaching Hospital
    Kurunegala, Sri Lanka
    Not yet recruiting
  • Kothalawala Defence University Hospital
    Werahera, Sri Lanka
    Not yet recruiting
  • Barts Health NHS Trust
    London, United Kingdom
    Withdrawn
  • Manchester University NHS Foundation Trust
    Manchester, United Kingdom
    Not yet recruiting
  • Salford Royal NHS Foundation Trust
    Salford, United Kingdom
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Surovatamig for adults with anti‑PLA2R primary membranous nephropathy

    This study will test whether subcutaneous surovatamig is safe and can reduce heavy proteinuria in adults with anti‑PLA2R–positive primary membranous nephropathy.

    Recruiting Phase 2 AstraZeneca · Los Angeles, California and 26 other locations · NCT07571746

  • Transformative 2.0 for diabetic kidney disease

    This project will try to see if adults with diabetic kidney disease who take SGLT2 diabetes medicines have different biological patterns in archived kidney tissue than similar people who do not take these medicines.

    Recruiting University of Pennsylvania · Philadelphia, Pennsylvania · NCT07444203

  • SHR-2173 injections for adults with primary membranous nephropathy

    This Phase II test will try SHR-2173 injections in adults (18–75) with biopsy-proven primary membranous nephropathy to see if they are safe, reduce disease activity, and to measure how the drug acts in the body.

    Recruiting Phase 2 Guangdong Hengrui Pharmaceutical Co., Ltd · Nanjing, Jiangsu · NCT07289763

  • Povetacicept for people with primary membranous nephropathy

    This trial tests whether povetacicept is safe and helps people with primary membranous nephropathy, with tacrolimus listed as an intervention in the protocol.

    Recruiting at 116 sites Phase 2/3 Vertex Pharmaceuticals Incorporated · Montgomery, Alabama and 116 other locations · NCT07204275

  • ACE Reno Pico Cell Matrix for reducing proteinuria and supporting kidney function

    This trial will test whether taking ACE Reno, a sublingual peptide solution four times daily for 12 weeks, can lower urine protein and help stabilize kidney function in adults with nephropathy or chronic kidney disease.

    Recruiting Phase 4 Ace Cells Lab Limited · Giza, GZ · NCT07187713

  • ALXN1920 for adults with primary membranous nephropathy

    This trial will test whether ALXN1920 reduces urine protein in adults with primary membranous nephropathy who are at high risk of progression compared with placebo.

    Recruiting at 35 sites Phase 2 Alexion Pharmaceuticals, Inc. · Loma Linda, California and 39 other locations · NCT07157787

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.