Clinical Trials List
Protocol NumberCHK01-01
NCT Number(ClinicalTrials.gov Identfier)NCT04573478
2021-03-01 - 2025-11-30
Phase III
Not yet recruiting3
Recruiting2
ICD-10N02.8
Recurrent and persistent hematuria with other morphologic changes
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Chinook Therapeutics U.S., Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 林裕 Division of Nephrology
- I-jen Chiu Division of Nephrology
- YUNG-HO HSU Division of Nephrology
- Yu-Wei Chen Division of Nephrology
- Mei-Yi Wu Division of Nephrology
- Cai-Mei Zheng Division of Nephrology
- Li-Yee Hong Division of Nephrology
- Chia-Te Liao Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
IgA Nephropathy at Risk of Progressive Loss of Renal Function
Objectives
Primary Objectives
• To evaluate the effect of atrasentan versus placebo on proteinuria levels at Week 24
Secondary Objectives
• To evaluate the effect of atrasentan
versus placebo on change from
baseline to Week 136 (4 weeks post
cessation of randomized treatment)
in estimated glomerular filtration
rate (eGFR)
• To compare 2-year on-treatment
rates of change in eGFR between
atrasentan and placebo (eGFR slope
Week 12 to Week 120 of
randomized treatment)
• To compare the total on-study rates
of change in eGFR between
atrasentan and placebo (eGFR slope
from baseline to Week 136)
• Additional efficacy outcomes
• To characterize the safety and
tolerability of atrasentan compared
to placebo
Test Drug
Atrasentan
Active Ingredient
Atrasentan
Dosage Form
film-coated tablet
Dosage
0.75mg
Endpoints
• The change in proteinuria (urine protein:creatinine ratio [UPCR] based on 24-hour urine collection) from baseline to
Week 24.
• Change from baseline to final study visit (Week 136) in eGFR, using the chronic kidney disease-epidemiology collaboration
(CKD-EPI) creatinine equation
• Rate of change in eGFR during 2 years on treatment as measured through a chronic slope calculated from values at Week 12
through to Week 120
• Rate of change in eGFR during the study as measured through a total slope calculated from values at baseline to
Week 136
• Percent of subjects achieving proteinuria reduction to < 1 g/day at Week 24 and 40% decrease in UPCR from baseline
• Percent of subjects experiencing at least a 30% reduction in eGFR or reach end-stage kidney disease (ESKD) during the study
• Percent of subjects experiencing at least a 40% reduction in eGFR or reach ESKD during the study
• Type, incidence, severity, grading, seriousness, and relatedness of adverse events (AEs)
Week 24.
• Change from baseline to final study visit (Week 136) in eGFR, using the chronic kidney disease-epidemiology collaboration
(CKD-EPI) creatinine equation
• Rate of change in eGFR during 2 years on treatment as measured through a chronic slope calculated from values at Week 12
through to Week 120
• Rate of change in eGFR during the study as measured through a total slope calculated from values at baseline to
Week 136
• Percent of subjects achieving proteinuria reduction to < 1 g/day at Week 24 and 40% decrease in UPCR from baseline
• Percent of subjects experiencing at least a 30% reduction in eGFR or reach end-stage kidney disease (ESKD) during the study
• Percent of subjects experiencing at least a 40% reduction in eGFR or reach ESKD during the study
• Type, incidence, severity, grading, seriousness, and relatedness of adverse events (AEs)
Inclution Criteria
1.Male and female subjects aged 18 and older at the time of signing the ICF prior to initiation of any study specific activities/procedures.
2.Biopsy-proven IgAN that, in the opinion of the Investigator, is not due to secondary causes.
•Biopsy could have occurred at any point in time prior to study.
•A diagnostic report must be available for review by the Sponsor or designee.
3.Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to screening.
•Investigator discretion should be used in determining maximally tolerated and optimized dose.
•Subjects who are intolerant to RAS inhibitors are eligible, buteligible but will not exceed ~5% of total population randomized.
4.UPCR ≥1 g/g (≥1000 mg/g) based on a central laboratory assessment of first morning void urine collected at screening.
5.eGFR of at least 30 mL/min/1.73 m2 at screening based on the CKD-EPI equation.
6.Willing to abide with highly effective forms of contraception, as specified in the protocol, throughout the study and for 1 month afterward. In WOCBP, use of hormonal contraceptive agents must have been started at least 1 month prior to baseline.
Informed Consent
7.Willing and able to provide written informed consent and comply with all study visits and study procedures.
2.Biopsy-proven IgAN that, in the opinion of the Investigator, is not due to secondary causes.
•Biopsy could have occurred at any point in time prior to study.
•A diagnostic report must be available for review by the Sponsor or designee.
3.Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to screening.
•Investigator discretion should be used in determining maximally tolerated and optimized dose.
•Subjects who are intolerant to RAS inhibitors are eligible, buteligible but will not exceed ~5% of total population randomized.
4.UPCR ≥1 g/g (≥1000 mg/g) based on a central laboratory assessment of first morning void urine collected at screening.
5.eGFR of at least 30 mL/min/1.73 m2 at screening based on the CKD-EPI equation.
6.Willing to abide with highly effective forms of contraception, as specified in the protocol, throughout the study and for 1 month afterward. In WOCBP, use of hormonal contraceptive agents must have been started at least 1 month prior to baseline.
Informed Consent
7.Willing and able to provide written informed consent and comply with all study visits and study procedures.
Exclusion Criteria
1.Concurrent diagnosis of another cause of chronic kidney disease including diabetic kidney disease or another primary glomerulopathy.
2.Clinical suspicion of rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines or clinical suspicion of Henoch-Schonlein Purpura.
3.Diagnosis of nephrotic syndrome with serum albumin < 3 g/dL at screening.
4.BNP value of > 200 pg/mL at screening.
5.Platelet count <80,000 per µL at screening
6.History of organ transplantation (subjects with history of corneal transplant are not excluded).
7.Use of systemic immunosuppressant medications including 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.
8.Confirmed blood pressure >150 mmHg systolic or >95 mmHg diastolic based on a mean of 3 measurements obtained at screening.
9.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.
10.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).
11.Hemoglobin below 9 g/dL at screening or prior history of blood transfusion for anemia within 3 months of screening.
12.History of malignancy unless cancer free for at least 5 years or nonmelanoma skin cancer not requiring ongoing treatment. A subject with curatively treated cervical carcinoma in situ is eligible for this study.
13.Pregnancy, breast feeding, or intent to become pregnant during the study period and at least 1 month afterward for females.
14.Intent to father a child or donate sperm during the study period and at least 1 month afterward for males.
15.Have received any investigational agent 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.
16.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.
17.History of an alcohol or illicit drug-related disorder within the past 3 years.
2.Clinical suspicion of rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines or clinical suspicion of Henoch-Schonlein Purpura.
3.Diagnosis of nephrotic syndrome with serum albumin < 3 g/dL at screening.
4.BNP value of > 200 pg/mL at screening.
5.Platelet count <80,000 per µL at screening
6.History of organ transplantation (subjects with history of corneal transplant are not excluded).
7.Use of systemic immunosuppressant medications including 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.
8.Confirmed blood pressure >150 mmHg systolic or >95 mmHg diastolic based on a mean of 3 measurements obtained at screening.
9.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.
10.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).
11.Hemoglobin below 9 g/dL at screening or prior history of blood transfusion for anemia within 3 months of screening.
12.History of malignancy unless cancer free for at least 5 years or nonmelanoma skin cancer not requiring ongoing treatment. A subject with curatively treated cervical carcinoma in situ is eligible for this study.
13.Pregnancy, breast feeding, or intent to become pregnant during the study period and at least 1 month afterward for females.
14.Intent to father a child or donate sperm during the study period and at least 1 month afterward for males.
15.Have received any investigational agent 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.
16.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.
17.History of an alcohol or illicit drug-related disorder within the past 3 years.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
320 participants
