NIPH Clinical Trials Search

JRCT ID: jRCT2071210028

Registered date:25/05/2021

The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedIgA Nephropathy at Risk of Progressive Loss of Renal Function
Date of first enrollment27/09/2021
Target sample size24
Countries of recruitmentArgentina,Japan,Australia,Japan,Brazil,Japan,Canada,Japan,China,Japan,Colombia,Japan,Czech Republic,Japan,France,Japan,Germany,Japan,Hong Kong,Japan,India,Japan,Italy,Japan,New Zealand,Japan,Poland,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan
Study typeInterventional
Intervention(s)Drug: Atrasentan Film-coated tablet Other Names: CHK-01 Atrasentan Hydrochloride ABT-627 Drug: Placebo Film-coated tablet


Primary OutcomeThe change in proteinuria (urine protein:creatinine ratio [UPCR] based on 24-hour urine collection) from baseline to Week 24
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include criteriaAge and Sex 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. Types of Subjects and Disease Characteristics 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 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. Pregnancy and Contraception 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.
Exclude criteria5.2 EXCLUSION CRITERIA Subjects must meet NONE of the following exclusion criteria to be enrolled. 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 uL 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.

Related Information


Public contact
Name Tomoaki Fukui
Address 1-21-28 Ichigo Hakata Ekimae Square, Hakataekimae, Hakata-ku, Fukuoka 812-0011 Fukuoka Japan 812-0011
Telephone +81-80-1422-2455
Affiliation IQVIA Services Japan G.K.
Scientific contact
Name Tomoaki Fukui
Address 1-21-28 Ichigo Hakata Ekimae Square, Hakataekimae, Hakata-ku, Fukuoka 812-0011 Fukuoka Japan
Telephone +81-80-1422-2455
Affiliation IQVIA Services Japan G.K.