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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Walden Biosciences Industry-sponsored |
| Locations | 50 sites (Los Angeles, California and 49 other locations) |
| Status | Recruiting |
| Started | July 2, 2024 |
| Main results expected | March 2027 |
| Study ends | June 2027 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT06466135 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
- Study coordinator: Michelle Skupien
- Email: clinicaltrials@waldenbiosciences.com
- Phone: 8573141961
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.
-
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.
-
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.
-
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.
-
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.
-
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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.