CTIS2023-503828-13-00
Recruiting
Phase 1
A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects with IgA Nephropathy on Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) - CHK01-03
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ephrology
- Sponsor
- Chinook Therapeutics Inc.
- Enrollment
- 52
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects aged 18 and older at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures., Inclusion Criteria for Run\-In Subjects. Willing to participate in an 8\-week run\-in period with an SGLT2i., Additional Inclusion Criteria for Run\-in Subjects at the end of Run\-In. Must have completed the 8\-week run\-in period on a stable and well tolerated dose of an SGLT2i., Additional Inclusion Criteria for Run\-in Subjects at the end of Run\-In. Must have a 24\-hour total urine protein of \> 0\.5 grams/day confirmed at the Week \-1 visit, Additional Inclusion Criteria for Run\-in Subjects at the end of Run\-In. Must have an eGFR of \= 30 mL/min/1\.73 m2 based on the CKD\-EPI equation at their Week \-1 Visit\*. \* Please keep in mind for subjects that go through the run\-in period with SGLT2i, there is the potential for an acute eGFR reduction of about 10%, but can be up to 30% in rare cases (Meraz\-Muñoz, 2021; Heerspink, 2021a)., Subjects who are unable to fulfill the last 3 criteria during the run\-in period will be considered run\-in failures., Biopsy\-proven IgAN that, in the opinion of the investigator, is not due to secondary causes. a. Biopsy could have occurred at any point in time prior to study. b. A diagnostic report must be available for review by the Sponsor or designee., Receiving a maximally tolerated and stable dose of a renin\-angiotensin system inhibitor (RASi) for at least 12 weeks prior to screening. Investigator discretion should be used in determining maximally tolerated and optimized dose., eGFR \= 30 mL/min/1\.73 m2 at screening based on the CKD\-EPI equation (https://www.kidney.org/professionals/kdoqi/gfr\_calculator)., Willing to abide with highly effective forms of contraception, as specified in the protocol, throughout the study and for up to 1 month afterward. In WOCBP, use of hormonal contraceptive agents must have been started at least 1 month prior to baseline, Willing and able to provide written informed consent and comply with all study visits and study procedures., Inclusion Criteria for SGLT2i Stable Subjects. Receiving treatment with SGLT2i at a stable dose for at least 8 weeks prior to screening., Inclusion Criteria for SGLT2i Stable Subjects. Must have a 24\-hour total urine protein of \> 0\.5 grams/day, Inclusion Criteria for Run\-In Subjects. Must have a 24\-hour total urine protein of \>0\.85 grams/day at screening.
Exclusion Criteria
- •Concurrent diagnosis of another cause of chronic kidney disease including diabetic kidney disease or another primary glomerulopathy., Known history of heart failure or prior hospital admissions for conditions relating to fluid overload such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites., Known history of clinically significant liver disease or transaminase or bilirubin values more than twice the upper limit of normal. Subjects with treated hepatitis C can be considered for inclusion into the study upon consultation with the Sponsor’s Medical Monitor (or designee)., Hemoglobin below 9 g/dL at screening or prior history of blood transfusion for anemia within 3 months of screening., History of malignancy unless cancer free for at least 5 years or nonmelanoma skin cancer that was completely resected. A subject with curatively treated cervical carcinoma in situ is eligible for this study., Pregnancy, breast feeding, or intent to become pregnant during the study period and at least 1 month afterward for females., Intent to father a child or donate sperm during the study period and at least 1 month afterward for males., Have received any investigational agent or approved treatment for IgAN (other than a RAS inhibitor and SGT2i) within 1 month (or 5 half\-lives of the agent, whichever is longer) prior to screening. If the investigational agent is a cytotoxic or immunosuppressive agent, then this washout period is 6 months., Concurrent clinically significant, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the Investigator or Sponsor’s Medical Monitor (or designee), might confound the results of the study or pose additional risk to the subject by their participation in the study, History of an alcohol or illicit drug\-related disorder within the past 1 year., Clinical suspicion of rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines or clinical suspicion of Henoch\-Schonlein Purpura (IgA vasculitis)., Clinical diagnosis of nephrotic syndrome., Diagnosis of Type 1 diabetes., Brain natriuretic peptide (BNP) value of \> 200 pg/mL at screening., Platelet count \<80,000 per µL at screening., History of organ transplantation (subjects with history of corneal transplant are not excluded)., Use of systemic immunosuppressant medications including systemic corticosteroids (e.g., prednisone, prednisolone, budesonide, etc.) mycophenolate, azathioprine, cyclosporine, tacrolimus, etc.; use of herbs such as Tripterygium Wilfordii Hook F, Caulis sinomenii and Sinomenium acutum; for \>2 weeks in the past 3 months. Use of rituximab within the past 6 months., Confirmed blood pressure \>150 mmHg systolic or \>95 mmHg diastolic based on a blood pressure measurement obtained at screening.
Outcomes
Primary Outcomes
Not specified
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