A Phase 3, Randomized, Double-blind, Placebocontrolled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)
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 (The ALIGN Study)
Fukui Tomoaki
IQVIA Services Japan G.K.
1-21-28 Ichigo Hakata Ekimae Square, Hakataekimae, Hakata-ku, Fukuoka 812-0011
+81-80-1422-2455
tomoaki.fukui@iqvia.com
Fukui Tomoaki
IQVIA Services Japan G.K.
1-21-28 Ichigo Hakata Ekimae Square, Hakataekimae, Hakata-ku, Fukuoka 812-0011
+81-80-1422-2455
tomoaki.fukui@iqvia.com
Recruiting
June. 01, 2021
Sept. 27, 2021
24
Interventional
randomized controlled trial
double blind
placebo control
parallel assignment
treatment purpose
Age 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.
5.2 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.
18age old over
No limit
Both
IgA Nephropathy at Risk of Progressive Loss of Renal Function
