NCT06466135RecruitingPhase 2
Study of WAL0921 in Patients With Glomerular Kidney Diseases
Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 12 Jun 2024
- Start date
- 2 Jul 2024
- Primary completion date
- Mar 2027
- Lead sponsor
- Walden Biosciences
- Diseases
- IgA nephropathy
- NCT number
- NCT06466135
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 96
- From 2 Jul 2024 to the primary completion date, Mar 2027
- 50 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of organ transplantation
- History of alcohol or substance use disorder
Other
- Currently pregnant or planning to become pregnant
- Acute dialysis or acute kidney injury within 6 months of Screening
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (50)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Western Health Sunshine Hospital Coordinator of this site? Confirm its status | St Albans | Australia | Recruiting |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
| Royal Derby Hospital Coordinator of this site? Confirm its status | Derby | United Kingdom | Recruiting |
| College of Life Sciences, University of Leicester Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Withdrawn |
| Manchester University NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Not yet recruiting |
| Salford Royal NHS Foundation Trust Coordinator of this site? Confirm its status | Salford | United Kingdom | Not yet recruiting |
| Mazumdar Shah Medical Center Coordinator of this site? Confirm its status | Bangalore | India | Active, not recruiting |
| MS Ramaiah Medical College and Hospitals Coordinator of this site? Confirm its status | Bangalore | India | Active, not recruiting |
| SUM Hospital Coordinator of this site? Confirm its status | Bhubaneswar | India | Active, not recruiting |
| Shri Guru Ram Rai Institute of Medical and Health Sciences Coordinator of this site? Confirm its status | Dehradun | India | Active, not recruiting |
| Nizam's Institute of Medical Sciences Coordinator of this site? Confirm its status | Hyderabad | India | Active, not recruiting |
| Osmania General Hospital Coordinator of this site? Confirm its status | Hyderabad | India | Active, not recruiting |
| SMS Medical College and Hospital Coordinator of this site? Confirm its status | Jaipur | India | Active, not recruiting |
| NRS Medical College and Hospital Kolkata Coordinator of this site? Confirm its status | Kolkata | India | Active, not recruiting |
| Sanjay Gandhi Post Graduate Institute of Medical Sciences Coordinator of this site? Confirm its status | Lucknow | India | Active, not recruiting |
| Nutema Hospital Coordinator of this site? Confirm its status | Meerut | India | Active, not recruiting |
| Muljibhai Patel Urological Hospital Coordinator of this site? Confirm its status | Nadiād | India | Active, not recruiting |
| Sir Ganga Ram Hospital Coordinator of this site? Confirm its status | New Delhi | India | Active, not recruiting |
| Max Super Speciality Hospital Coordinator of this site? Confirm its status | Patparganj | India | Active, not recruiting |
| Manipal Hospital Coordinator of this site? Confirm its status | Pune | India | Active, not recruiting |
| AIIMS Hospital Coordinator of this site? Confirm its status | Raipur | India | Active, not recruiting |
| MGM Medical Care and Hospital Coordinator of this site? Confirm its status | Sambhajinagar | India | Active, not recruiting |
| Dhiraj Hospital Coordinator of this site? Confirm its status | Vadodara | India | Active, not recruiting |
| Hallym University Sacred Heart Hospital Coordinator of this site? Confirm its status | Anyang | South Korea | Recruiting |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Severance Hospital Yonsei Cancer Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Soeul | South Korea | Recruiting |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
| National Hospital of Sri Lanka Coordinator of this site? Confirm its status | Colombo | Sri Lanka | Not yet recruiting |
| Jaffna Teaching Hospital Coordinator of this site? Confirm its status | Jaffna | Sri Lanka | Not yet recruiting |
| Kandy National Hospital Coordinator of this site? Confirm its status | Kandy | Sri Lanka | Not yet recruiting |
| Kurunegala Teaching Hospital Coordinator of this site? Confirm its status | Kurunegala | Sri Lanka | Not yet recruiting |
| Kothalawala Defence University Hospital Coordinator of this site? Confirm its status | Werahera | Sri Lanka | Not yet recruiting |
| Hospital Canselor Tuanku Muhriz UKM Coordinator of this site? Confirm its status | Cheras | Malaysia | Recruiting |
| Hospital Sultan Idris Shah Serdang Coordinator of this site? Confirm its status | Kajang | Malaysia | Recruiting |
| University Malaya Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Recruiting |
| Hospital Kuala Lumpur Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Recruiting |
| Hospital Tengku Ampuan Afzan Coordinator of this site? Confirm its status | Kuantan | Malaysia | Recruiting |
| Sunway Medical Centre Coordinator of this site? Confirm its status | Petaling Jaya | Malaysia | Recruiting |
| Fides Clinical Research Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Dunes Clinical Research Coordinator of this site? Confirm its status | Dakota Dunes | United States | Recruiting |
| Colorado Kidney and Vascular Care Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Nephrology Associates of Northern Illinois and Indiana (NANI) Coordinator of this site? Confirm its status | Hinsdale | United States | Recruiting |
| Clinical Trial Network Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Prolato Clinical Research Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Academic Medical Research Institute Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Clinical Advancement Center Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| D&H Tamarac Research Center Coordinator of this site? Confirm its status | Tamarac | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.