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Trials - SLCTR/2021/004

Protocol Change

Date

2021-06-29


Protocol

Protocol changed


Item Changed

Exclusion criteria


Previous Version

Participants are excluded from the study if they meet any of the following criteria: 1.Participant has secondary forms of IgAN as defined by the treating physician (eg,Henoch-Schonlein purpura, minimal change disease with IgA deposits, infection associated IgAN, or IgAN-associated with hepatic cirrhosis). 2.Participant has co-existing CKD, other than IgAN. 3.Participant has evidence of additional pathological findings in the kidney biopsy (eg,diabetic kidney disease, membranous nephropathy, or lupus nephritis). However, hypertensive vascular changes are acceptable. 4.Participant has kidney biopsy MEST or MEST-C score of T2 or C2 from the OxfordIgAN classification schema. If MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis or crescents in > 25% of glomeruli is exclusionary. 5.Participant has nephrotic syndrome, defined for this purpose as 24-hour urine protein>3.5 g with concurrent hypoalbuminemia (serum albumin < 2.5 g/dL), hyperlipidemia(total cholesterol > 350 mg/dL), and edema. 6.Participant has received a solid organ transplant, including kidney. 7.Participant has received bone marrow or hematologic stem cell transplantation. 8.Participant is currently receiving systemic immunosuppression (excluding topical, ophthalmic, per rectum, or inhaled corticosteroids). 9.Participant has received systemic steroids within the 24 weeks prior to initial screening. 10.Participant has received treatment with 2 or more systemic immunosuppressive agents within 2 years prior to initial screening. 11.Participant has chronic infectious diseases (eg, chronic urinary tract infection; chronicsinusitis; bronchiectasis; active pulmonary or systemic tuberculosis; chronic viralhepatitis, such as hepatitis C or hepatitis B; or human immunodeficiency virus infection). Participant has acute infectious disease at the time of screening. Participants may be re-screened following resolution of acute infection (such as urinary tract infection or respiratory tract infection), provided there is no evidence of an immunosuppressive condition that predisposed the participant to this infection. Participant has Type 1 diabetes. Participant has uncontrolled Type 2 diabetes, as evidenced by a screening hemoglobin A1c value > 8%. Participant has uncontrolled BP (> 140 mm Hg systolic or > 90 mm Hg diastolic), Systolic and diastolic BP should be assessed while the participant is seated or supine for at least 5 minutes in a quiet room without distractions. BP should be measured with a completely automated device. At least 3 readings should be taken and average values from these 3 readings should be calculated. Participant has a history of chronic autoimmune neurodegenerative disorder such as multiple sclerosis. Participant has a known allergy or intolerance to any component of the study intervention. Participant is breastfeeding. Participant has poorly compensated or controlled ischemic heart disease or cardiomyopathy, as judged by the Investigator. Participant has chronic obstructive pulmonary disease (COPD) or asthma that has required systemic steroid therapy during the prior year. If COPD is present, severity must not exceed Global Initiative for Chronic Obstructive Lung Disease 1 (mild), defined as a forced 1-second expiratory volume (FEV1) > 80% of predicted. Participant has known cirrhosis or liver dysfunction, defined as presence of coagulopathy, platelet count < 100,000/micro-litre or alanine aminotransferase > 3× upper limit of normal. Participant has active malignancy or is receiving chemotherapy for malignancy, except for nonmelanoma skin cancers and cervical carcinoma in situ. Participants with prior malignancy who have been documented to be cancer-free for greater than or equal to 5 years may be enrolled. Participant is planning or scheduled to undergo a tonsillectomy. Prior tonsillectomy is acceptable (if greater than 6 months prior to screening). Participant has enrolled in another investigational drug or device study within 3 months prior to initial screening. Participant with a pre-existing illness other than those listed above that, in the opinion of the Investigator, would place the participant at increased risk through participation in this study. Participant is unable to comply with study protocol procedures and/or study visit schedules. Participant with known or suspected alcohol or drug abuse that would compromise their safety or study participation, in the opinion of the Investigator.


Next Version

1. Participant has secondary forms of IgAN as defined by the treating physician (eg, Henoch-Sch?nlein purpura (IgA vasculitis), infection-associated IgAN, or IgAN associated with hepatic cirrhosis). 2. Participant has co-existing chronic kidney disease, other than IgAN. 3. Participant has evidence of additional pathological findings in the kidney biopsy (eg, diabetic kidney disease, membranous nephropathy, or lupus nephritis). However, hypertensive vascular changes are acceptable. 4. Participant has kidney biopsy MEST or MEST-C score of T2 or C2 from the Oxford IgAN classification schema. If MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis, or crescents in > 25% of glomeruli is exclusionary. 5. Participant has nephrotic syndrome, defined for this purpose as 24-hour urine protein > 3.5 g with concurrent hypoalbuminemia (serum albumin < 2.5 g/dL), hyperlipidemia (total cholesterol > 350 mg/dL), and edema. Participants with isolated nephrotic range proteinuria (> 3.5 g/day) will be eligible. 6. Participant has received a solid organ transplant, including kidney. 7. Participant has received bone marrow or hematologic stem cell transplantation. 8. Participant is currently receiving systemic immunosuppression (excluding topical, ophthalmic, per rectum, or inhaled corticosteroids). 9. Participant has received treatment with systemic corticosteroid therapy (excluding topical, ophthalmic, per rectum, or inhaled corticosteroids) within 16 weeks of initial screening. 10. Participant has received treatment with a systemic immunosuppressive agent (e.g., mycophenolate mofetil, azathioprine, calcineurin inhibitors, cyclophosphamide/cytotoxic agents) within 16 weeks of initial screening. 11. Participant has any chronic infectious disease (eg, chronic urinary tract infection; chronic sinusitis; bronchiectasis; active pulmonary or systemic tuberculosis; chronic viral hepatitis, such as hepatitis C or hepatitis B; or human immunodeficiency virus infection). 12. Participant has acute infectious disease at the time of screening. Participants may be rescreened following resolution of acute infection (such as urinary tract infection or respiratory tract infection), provided there is no evidence of an immunosuppressive condition that predisposed the participant to this infection. 13. Participant has Type 1 diabetes. 14. Participant has uncontrolled Type 2 diabetes, as evidenced by a screening hemoglobin A1c value > 8%. 15. Participant has uncontrolled BP (> 140 mm Hg systolic or > 90 mm Hg diastolic). 16. Participant has a history of a chronic autoimmune neurodegenerative disorder such as multiple sclerosis.