Health Condition 1: N29- Other disorders of kidney and ureter in diseases classified elsewhere
Conditions
Interventions
Intervention1: Atacicept: Participants will be randomized into 1 of 5 treatment arms in a 1:1:1:1:1 ratio to receive 300 mg, 450 mg, or 600 mg atacicept Q4W SC injection for 24 weeks, 150 mg atacicept
Sponsors
Vera Therapeutics, Inc.
Ms Worldwide Clinical Trials India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Must have the ability to understand and sign a written informed consent form which must be obtained prior to initiation of study assessments 2 Adult male or female of greater than or equal to 18 years of age or as per country specific legally or nationally recognized adult age who provides written informed consent prior to performing any study assessments 3 Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years of the screening visit 4 Total urine protein excretion greater than or equal to zero point 75 g per 24 hour or urine protein to creatinine ratio UPCR greater than or equal to zero point 75 mg per mg based on a 24 hour urine sample during the screening period 5 eGFR greater than or equal to 30 mL per min per 1 point 73 m2 at screening as per the Chronic Kidney Disease Epidemiology Collaboration CKD EPI equation 6 On a stable prescribed regimen of RASi ACEi or ARB for at least 8 weeks that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1 The participant is eligible if they do not tolerate RASi provided their management of IgAN is standard of care per local practice This intolerance must be documented by the investigator and discussed with the Medical Monitor SGLT2i MRA ERA and or GLP 1RA are permitted provided the dosing regimens is stable for at least 8 weeks prior to screening 7 Systolic blood pressure less than or equal to 160 mmHg and diastolic blood pressure less than or equal to 90 mmHg at screening 8 A female is eligible if she is not pregnant that is after a confirmed menstrual period a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1 not breastfeeding for at least 3 months prior to screening and at least one of the following conditions applies Is not a woman of childbearing potential WOCBP as defined in Appendix 1 OR Is a WOCBP who agrees to use a highly effective contraceptive method that is has a failure rate of less than 1 percent per year as listed in Appendix 1 at least 7 days prior to randomization through 175 days after the last dose of study drug
Exclusion criteria
Exclusion criteria: 1 Participation in a study of atacicept or any previous treatment with atacicept 2 IgAN secondary to another condition eg liver cirrhosis or other causes of mesangial IgA deposition including IgA vasculitis example Henoch-Schonlein purpura systemic lupus erythematosus dermatitis herpetiformis ankylosing spondylitis 3 Evidence of rapidly progressive glomerulonephritis loss of greater than or equal to 50 Percentage of eGFR within 3 months of screen 4 Total urine protein excretion greater than or equal to 5g per 24 hours or UPCR greater than or equal to 5 mg per mg based on a 24 hour urine sample during the screening perioding 5 Evidence of nephrotic syndrome within 6 months of screening serum albumin less than 3point0 g per dL in association with UPCR greater than 3point5 mg per mg 6 Renal or other organ transplantation prior to or expected during the study, with the exception of corneal transplants 7 Concomitant chronic renal disease in addition to IgAN example diabetic nephropathy primary focal segmental glomerulosclerosis membranous nephropathy C3 glomerulopathy, lupus nephritis 8 Uncontrolled diabetes defined as hemoglobin A1c HbA1c greater than 7point5 percentage at screening 9 History of tuberculosis TB, untreated latent TB infection LTBI or evidence of active TB determined by a positive Quantiferon test at the screening visit If the participant is undergoing current treatment for LTBI they must have received at least 4 continuous weeks of an appropriate LTBI treatment prior to the screening visit without evidence of reexposure to be eligible for this study If on LTBI treatment at the screening visit the participant will be expected to complete an appropriate LTBI treatment regimen to remain in the study Participants with current household contacts with active TB will be excluded unless prophylaxis treatment has been completed and evidence that household contacts have completed treatment is provided Indeterminate Quantiferon tests may be repeated once by the same test and will be considered positive if retest results are positive or indeterminate 10 Use of any of the following prohibited medications Systemic corticosteroids including oral budesonide for the treatment of IgAN within 6 months prior to screening from screening to Day 1 or expected use during the study For glucocorticosteroids systemic is defined as oral rectal or injectable intravenous or intramuscular routes of administration Other routes of administration are allowed including intra articular inhaled topical ophthalmic otic and intranasal For nonIgAN indications eg gout flare exacerbation of asthma severe rash etc as follows Within 12 weeks prior to randomization Use of systemic corticosteroids or immunosuppressive medications for greater than 1 week or average dose greater than 0point5 mg per kg per day prednisolone or equivalent Immunosuppressive medications example mycophenolate mofetil MMF, azathioprine cyclophosphamide hydroxychloroquine for the treatment of IgAN within 12 weeks prior to screening from screening to Day 1 or expected use during the study Use of traditional Chinese medications and or Ayurvedic medications for IgAN within 12 weeks prior to screening from screening to Day 1 or during the study period Including but not limited to Lei Gong Teng Tripterygium Wilfordii Hook F Caulis sinomenii and Sinomenium acutum Any other medic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN Timepoint: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the safety and tolerability of atacicept at different dosing regimensTimepoint: ;Evaluate the effect of atacicept on serum immunoglobulins (IgA, IgG, IgM)Timepoint: WEEK 24;Evaluate serum PK of ataciceptTimepoint: End of the study;Evaluate the immunogenicity of ataciceptTimepoint: End of the study;Evaluate the effect of atacicept on change in proteinuriaTimepoint: End of the study | — |
Countries
Australia, Hungary, India, Malaysia, Philippines, Poland, Republic of Korea, Spain, Turkey, United Kingdom, United States of America
Contacts
Public ContactRengadurai Ramakrishnan
Worldwide Clinical Trials
Outcome results
None listed