Health Condition 1: N08- Glomerular disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: WAL0921: WAL0921, an anti-soluble urokinase plasminogen activator receptor (anti-suPAR) humanized immunoglobulin (Ig)G1 monoclonal antibody.
WAL0921 (50 mg/mL) is provided as a clear t
Sponsors
Walden Biosciences, Inc.
Emerald Clinical Trials India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of one of the following glomerular kidney diseases with elevated urine albumin creatinine ratio (UACR) or urine protein to creatinine ratio (UPCR) based on 24-hour urine during the Screening period: a. DN: Clinical diagnosis of DN; Type 1 or Type 2 diabetes mellitus with CKD not secondary to other etiologies; UACR 500-3500 mg albumin per g creatinine. b. FSGS or TR-MCD: Diagnosis based on renal biopsy within 7 years of Screening or disease-causing genetic mutation associated with FSGS with UPCR greater than or equal to 1.0 g protein per g creatinine at Screening. i. For FSGS, a disease-causing genetic mutation may be considered instead of renal biopsy. ii. TR-MCD must also lack response to at least more than 16 weeks of glucocorticoid therapy. c. IgAN: Diagnosis based on renal biopsy within 7 years of Screening with UPCR greater than or equal to 0.75 g protein per g creatinine at Screening. d. PMN: Diagnosis based on renal biopsy within 7 years of Screening with i, ii, or iii below, and UPCR not decreasing more than 50% in the last 6 months: i. UPCR greater than or equal to 5 g protein per g creatinine after maximum tolerated standard of care (SoC) for more than or at least 3 months, or ii. UPCR greater than or equal to 4 g protein per g creatinine after maximum tolerated SoC for more than or at least 6 months, or iii. UPCR greater than or equal to 3.5 g protein per g creatinine and serum albumin less than or equal to 3.0 g per dL prior to Screening. 2. Estimated glomerular filtration rate (eGFR), calculated by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI 2021) equation method, greater than or equal to 30 mL per min per 1.73 m2 at Screening. 3. If receiving an angiotensin-converting enzyme (ACE) inhibitor, an angiotensin II receptor blocker (ARB), endothelin and angiotensin II receptor antagonist, sodium-glucose co-transporter-2 (SGLT2) inhibitors, glucagon-like peptide-1 (GLP-1) agonists, and/or aldosterone antagonists, subjects should be stable on maximum tolerated daily dose as per local standard for at least 12 weeks prior to Screening and maintain prescribed dose for the duration of the study unless a safety issue is associated with that medication. 4. No longer receiving budesonide and completed a 9-month course of treatment, or unable to tolerate budesonide treatment or agree not to initiate budesonide for the duration of study, except budesonide administered by inhalation is allowed. 5. If taking corticosteroid therapy (i.e., prednisone), stable dose of less than or equal to 15 mg per day or less than or equal to 30 mg on alternate days for at least 8 weeks prior to Screening with no plan to change the dose or regimen during the study. 6. Persons of child-bearing potential must have a negative pregnancy test and must agree to either abstain from sex or to use highly effective method(s) of birth control based on the subject`s preferred and usual lifestyle from the date of dosing through the duration of the study and for at least 24 weeks after their last dose of study treatment. The barrier method should only be used if local regulatory authorities also consider this to be a highly effective method of birth control. 7. Persons of non-childbearing potential are at least 12 months postmenopausal confirmed by follicle stimulating hormone (FSH) more than 40 IU or 6 weeks after surgical
Exclusion criteria
Exclusion criteria: 1. Currently pregnant, breast-feeding, or planning to become pregnant within 12 months of Screening. 2. History of organ or bone marrow transplantation, including renal transplantation. 3. Currently on an organ transplant waiting list or there is a reasonable possibility of undergoing an organ transplant within 10 months of Screening. 4. Body Mass Index (BMI) greater than or equal to 40 kg per m2. 5. History of malignancy, unless in remission for at least 2 years other than basal cell or squamous cell skin carcinoma, cervical carcinoma in situ, or prostate cancer not expected to require treatment over the course of the study. 6. History of alcohol or substance use disorder within 12 months prior to Screening. 7. Uncontrolled systemic hypertension with systolic blood pressure more than 160 mmHg and diastolic blood pressure greater than or equal to 100 mmHg at Screening. 8. Acute dialysis or acute kidney injury within 6 months prior to Screening. 9. Histological FSGS subtype of collapsing variant. 10. On renal biopsy, rapidly progressive glomerulonephritis (RPGN) and/or more than 25% crescents and/or more than 50% tubulointerstitial fibrosis on biopsy. 11. Secondary FSGS that develops as an adaptive response to glomerular hypertrophy or hyperfiltration including disorders associated with a reduced renal mass and/or renal vasodilation, such as unilateral renal agenesis. Other secondary FSGS associated with drugs and toxins (i.e., heroin, interferon, pamidronate) and viral infections (i.e., human immunodeficiency virus [HIV]). 12. Diagnosis of IgA vasculitis. 13. Secondary IgAN associated with cirrhosis, celiac disease, HIV infection, dermatitis herpetiformis, seronegative arthritis, small cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, familial Mediterranean fever, etc. 14. Secondary membranous nephropathy associated with a history of drug use (such as excessive use of nonsteroidal anti-inflammatory drugs [NSAIDs]), infections (such as hepatitis B or C), autoimmune diseases (such as systemic lupus erythematosus [SLE]), or cancer. 15. Hospitalization for congestive heart failure (CHF) within 6 months, or cerebrovascular accident (CVA) or myocardial infarction (MI) within 3 months of Screening. 16. Life expectancy of less than 1 year at Screening. 17. Liver transaminase levels more than 2 times of ULN, active hepatobiliary disease, jaundice, and/or hepatitis. Gilbert`s syndrome is acceptable if direct bilirubin is less than or equal to ULN. 18. History of seizures or history of epilepsy. 19. History of serious mental illness. 20. Positive serology for HIV type 1 or 2, hepatitis B surface antigen, or hepatitis C RNA. 21. Active or chronic tuberculosis. 22. History of inadequate venous access and/or experience of difficulty donating blood. 23. History of angioedema and/or anaphylactic reactions. 24. 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. 25. Positive test for alcohol or illegal drugs of abuse at Screening or Day 0. 26. Treated with rituximab within 24 weeks of Screening, or cyclophosphamide, mycophenolate mofetil, azathioprine, calcineurin inhibitors, budesonide or abatacept w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs)Timepoint: Throughout 40 weeks of study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically significant changes in safety laboratory parameters, PE findings, vital signs, or electrocardiograms (ECGs) (including QTcF).Timepoint: Throughout 40 weeks of study period.;Percentage change from baseline in UACR or UPCR based on quantitative 24-hour urine collections.Timepoint: At baseline, 12, 18, 24, 30, and 36 weeks.;Spot urine UACR or UPCR in subjects with DN or rare glomerular disease, respectively.Timepoint: At baseline, 4, and 8 weeks.;Percentage change from baseline in eGFR from baseline renal function.Timepoint: At 12, 18, 24, 30, and 36 weeks.;Slope of eGFRTimepoint: At 12, 18, 24, 30, and 36 weeks.;Proportion achieving a complete remission (CR) as UACR or UPCR less than 0.5g/g in subjects with DN or rare glomerular disease, respectively.Timepoint: At 12, 18, 24, 30, and 36 weeks.;Proportion with a UACR or UPCR decrease of at least 30% from baseline in subjects with DN or rare glomerular disease, respectively.Timepoint: At 12, 18, 24, 30, and 36 weeks.;Proportion with a UACR or UPCR decrease of at least 40% from baseline in subjects with DN or rare glomerular disease, respectively.Timepoint: At 12, 18, 24, 30, and 36 weeks.;Proportion with a UACR or UPCR decrease of at least 50% from baseline in subjects with DN or rare glomerular disease, respectively.Timepoint: At 12, 18, 24, 30, and 36 weeks. | — |
Countries
Australia, India, Malaysia, Republic of Korea, Spain, Sri Lanka, United Kingdom, United States of America
Contacts
Public ContactKuldeep Patil
Emerald Clinical Trials India Private Ltd
Outcome results
None listed