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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
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

Full criteria on ClinicalTrials.gov

Sites (50)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Western Health Sunshine Hospital
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St AlbansAustraliaRecruiting
Westmead Hospital
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WestmeadAustraliaRecruiting
Royal Derby Hospital
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DerbyUnited KingdomRecruiting
College of Life Sciences, University of Leicester
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LeicesterUnited KingdomRecruiting
Barts Health NHS Trust
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LondonUnited KingdomWithdrawn
Manchester University NHS Foundation Trust
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ManchesterUnited KingdomNot yet recruiting
Salford Royal NHS Foundation Trust
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SalfordUnited KingdomNot yet recruiting
Mazumdar Shah Medical Center
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BangaloreIndiaActive, not recruiting
MS Ramaiah Medical College and Hospitals
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BangaloreIndiaActive, not recruiting
SUM Hospital
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BhubaneswarIndiaActive, not recruiting
Shri Guru Ram Rai Institute of Medical and Health Sciences
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DehradunIndiaActive, not recruiting
Nizam's Institute of Medical Sciences
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HyderabadIndiaActive, not recruiting
Osmania General Hospital
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HyderabadIndiaActive, not recruiting
SMS Medical College and Hospital
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JaipurIndiaActive, not recruiting
NRS Medical College and Hospital Kolkata
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KolkataIndiaActive, not recruiting
Sanjay Gandhi Post Graduate Institute of Medical Sciences
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LucknowIndiaActive, not recruiting
Nutema Hospital
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MeerutIndiaActive, not recruiting
Muljibhai Patel Urological Hospital
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NadiādIndiaActive, not recruiting
Sir Ganga Ram Hospital
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New DelhiIndiaActive, not recruiting
Max Super Speciality Hospital
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PatparganjIndiaActive, not recruiting
Manipal Hospital
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PuneIndiaActive, not recruiting
AIIMS Hospital
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RaipurIndiaActive, not recruiting
MGM Medical Care and Hospital
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SambhajinagarIndiaActive, not recruiting
Dhiraj Hospital
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VadodaraIndiaActive, not recruiting
Hallym University Sacred Heart Hospital
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AnyangSouth KoreaRecruiting
Pusan National University Hospital
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BusanSouth KoreaRecruiting
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaRecruiting
Severance Hospital Yonsei Cancer Center
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SoeulSouth KoreaRecruiting
Ajou University Hospital
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SuwonSouth KoreaRecruiting
National Hospital of Sri Lanka
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ColomboSri LankaNot yet recruiting
Jaffna Teaching Hospital
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JaffnaSri LankaNot yet recruiting
Kandy National Hospital
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KandySri LankaNot yet recruiting
Kurunegala Teaching Hospital
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KurunegalaSri LankaNot yet recruiting
Kothalawala Defence University Hospital
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WeraheraSri LankaNot yet recruiting
Hospital Canselor Tuanku Muhriz UKM
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CherasMalaysiaRecruiting
Hospital Sultan Idris Shah Serdang
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KajangMalaysiaRecruiting
University Malaya Medical Centre
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Kuala LumpurMalaysiaRecruiting
Hospital Kuala Lumpur
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Kuala LumpurMalaysiaRecruiting
Hospital Tengku Ampuan Afzan
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KuantanMalaysiaRecruiting
Sunway Medical Centre
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Petaling JayaMalaysiaRecruiting
Fides Clinical Research
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AtlantaUnited StatesRecruiting
Dunes Clinical Research
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Dakota DunesUnited StatesRecruiting
Colorado Kidney and Vascular Care
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DenverUnited StatesRecruiting
Nephrology Associates of Northern Illinois and Indiana (NANI)
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HinsdaleUnited StatesRecruiting
Clinical Trial Network
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HoustonUnited StatesRecruiting
Prolato Clinical Research Center
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HoustonUnited StatesRecruiting
Academic Medical Research Institute
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Los AngelesUnited StatesRecruiting
Clinical Advancement Center
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San AntonioUnited StatesRecruiting
D&H Tamarac Research Center
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TamaracUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.