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A study to learn if atrasentan is safe and works in people with IgA nephropathy who are taking an SGLT2i
EU CTIS ID: 2023-503828-13-00
What this study is testing
To evaluate the efficacy of atrasentan vs placebo while on background therapy with SGLT2i
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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 Lead (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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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 Lead (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 Lead (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.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Malaysia
- Brazil
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Malaysia; Brazil; Australia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.