Safety and Efficacy of WAL0921 vs Placebo in Patients with Glomerular Kidney Diseases and Proteinuria – A Phase 2 Randomized Controlled Trial

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2025/017

Enrollment

Unknown

Registered

2025-04-25

Start date

2025-03-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glomerular Kidney Diseases and Proteinuria

Interventions

Study sites: The National Hospital of Sri Lanka, General Sir John Kotelawala Defense University, Teaching Hospital Kurunegala, Jaffna Teaching Hospital, National Hospital Kandy. Randomization: Subje

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adults, aged 18-65 years 2. Biological males and females 3. 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 4. eGFR greater than or equal to 30 mL/min/1.73 m2

Exclusion criteria

Exclusion criteria: 1. Currently pregnant or planning to become pregnant 2. History of organ transplantation 3. History of alcohol or substance use disorder 4. Acute dialysis or acute kidney injury within 6 months of screening 5. 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

Design outcomes

Primary

Measure	Time frame
Incidence of treatment-emergent adverse events (TEAEs). As per the completed Phase 1 Study WAL0921-01 in healthy volunteers, following adverse-events (treatment related or unrelated) are anticipated in Study WAL0921-02 are: o Headache o Dizziness o Paresthesia o Somnolence o Nausea o Diarrhoea o Vomiting [At 4, 8, 12, 18, 24, 30, and 36 weeks] Efficacy assessment in the Phase 2 Study AL0921-02 involves measurement of a change in baseline proteinuria from 24-hr urine collection at the specified timepoints. Proteinuria is defined as:Ratio of urine albumin or urine protein to urine creatinine and is expressed as mg/g units [At 4, 8, 12, 18, 24, 30, and 36 weeks]	—

Measure

Time frame

Incidence of treatment-emergent adverse events (TEAEs). As per the completed Phase 1 Study WAL0921-01 in healthy volunteers, following adverse-events (treatment related or unrelated) are anticipated in Study WAL0921-02 are: o Headache o Dizziness o Paresthesia o Somnolence o Nausea o Diarrhoea o Vomiting [At 4, 8, 12, 18, 24, 30, and 36 weeks] Efficacy assessment in the Phase 2 Study AL0921-02 involves measurement of a change in baseline proteinuria from 24-hr urine collection at the specified timepoints. Proteinuria is defined as:Ratio of urine albumin or urine protein to urine creatinine and is expressed as mg/g units [At 4, 8, 12, 18, 24, 30, and 36 weeks]

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Secondary

Measure	Time frame
Clinically significant changes in safety laboratory parameters, physical examination (PE) findings, vital signs, or ECGs (including QTcF - QT interval corrected by Fridericia's formula). Safety lab listing: • Urine chemistry: 24 h total volume urine (ml), Creatinine 24h urine (mg/24hr), Microalb/cre ratio, 24h (mg/g), Microalbumin, 24hr ur (mg/24hr), Protein, 24hr urine (mg/24hr), Protein/cre ratio, 24hr (mg/g), Creatinine, random urine (mg/dl), Microalb/creat. Ratio (mg/g), Microalbumin, Random (mg/l)Protein, random ur (mg/dl), Protein/cre ratio (ran) (mg/g) • Chemistry: Alanine Aminotransferase (U/L),Albumin (g/dL), Alkaline Phosphatase (U/L), Aspartate Aminotransferase (U/L), Bicarbonate (mmol/L), Calcium (mg/dL), Chloride (mmol/L), Creatinine (mg/dL), Direct Bilirubin (mg/dL), Glomerular Filtration Rate, Estimated (mL/min/1.73m^2), Glucose (mg/dL), Potassium (mmol/L), Protein (g/dL), Sodium (mmol/L), Total Bilirubin (mg/dL), Urea Nitrogen (mg/dL) • Coagulation: Activated Partial Thromboplastin Time (seconds), D-Dimer (ng/mL FEU), Prothrombin Intl. Normalized Ratio (value), Prothrombin Time (seconds) • Hematology: Basophils (10^3/uL), Basophils/ Leukocytes (%), Eosinophils (10^3/uL), Eosinophils/ Leukocytes (%), Ery. Mean Corpuscular HGB Concentration (g/dL), Ery. Mean Corpuscular Hemoglobin (pg), Ery. Mean Corpuscular Volume (fL), Erythrocytes (10^6/uL), Erythrocytes Distribution Width (%), Hematocrit (%), Hemoglobin (g/dL), Immature Granulocytes (10^3/uL), Immature Granulocytes/Leukocytes (%), Leukocytes (10^3/uL), Lymphocytes (10^3/uL), Lymphocytes/Leukocytes (%), Mean Platelet Volume (fL), Monocytes (10^3/uL), Monocytes/Leukocytes (%), Neutrophils (10^3/uL), Neutrophils/Leukocytes (%), Nucleated Erythrocytes (10^3/uL), Nucleated Erythrocytes/Leukocytes (%), Platelets (10^3/uL) • Serology: HIV-1/2 Antibody (reactive/non-reactive), Hepatitis B Core Antibody (positive/negative), Hepatitis B Virus Surface Antigen (positive/negative), Hepatitis C Virus Anti	—

Measure

Time frame

Clinically significant changes in safety laboratory parameters, physical examination (PE) findings, vital signs, or ECGs (including QTcF - QT interval corrected by Fridericia's formula). Safety lab listing: • Urine chemistry: 24 h total volume urine (ml), Creatinine 24h urine (mg/24hr), Microalb/cre ratio, 24h (mg/g), Microalbumin, 24hr ur (mg/24hr), Protein, 24hr urine (mg/24hr), Protein/cre ratio, 24hr (mg/g), Creatinine, random urine (mg/dl), Microalb/creat. Ratio (mg/g), Microalbumin, Random (mg/l)Protein, random ur (mg/dl), Protein/cre ratio (ran) (mg/g) • Chemistry: Alanine Aminotransferase (U/L),Albumin (g/dL), Alkaline Phosphatase (U/L), Aspartate Aminotransferase (U/L), Bicarbonate (mmol/L), Calcium (mg/dL), Chloride (mmol/L), Creatinine (mg/dL), Direct Bilirubin (mg/dL), Glomerular Filtration Rate, Estimated (mL/min/1.73m^2), Glucose (mg/dL), Potassium (mmol/L), Protein (g/dL), Sodium (mmol/L), Total Bilirubin (mg/dL), Urea Nitrogen (mg/dL) • Coagulation: Activated Partial Thromboplastin Time (seconds), D-Dimer (ng/mL FEU), Prothrombin Intl. Normalized Ratio (value), Prothrombin Time (seconds) • Hematology: Basophils (10^3/uL), Basophils/ Leukocytes (%), Eosinophils (10^3/uL), Eosinophils/ Leukocytes (%), Ery. Mean Corpuscular HGB Concentration (g/dL), Ery. Mean Corpuscular Hemoglobin (pg), Ery. Mean Corpuscular Volume (fL), Erythrocytes (10^6/uL), Erythrocytes Distribution Width (%), Hematocrit (%), Hemoglobin (g/dL), Immature Granulocytes (10^3/uL), Immature Granulocytes/Leukocytes (%), Leukocytes (10^3/uL), Lymphocytes (10^3/uL), Lymphocytes/Leukocytes (%), Mean Platelet Volume (fL), Monocytes (10^3/uL), Monocytes/Leukocytes (%), Neutrophils (10^3/uL), Neutrophils/Leukocytes (%), Nucleated Erythrocytes (10^3/uL), Nucleated Erythrocytes/Leukocytes (%), Platelets (10^3/uL) • Serology: HIV-1/2 Antibody (reactive/non-reactive), Hepatitis B Core Antibody (positive/negative), Hepatitis B Virus Surface Antigen (positive/negative), Hepatitis C Virus Anti

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Countries

Australia,India,Korea, Democratic People's Republic of,Malaysia,Spain,Sri Lanka,United Kingdom,United States

Contacts

Public ContactDr. Selvarajah Mathu, MBBS, MD

Consultant nephrologist

mathuselvarajah@gmail.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026