EUCTR2020-003084-26-CZ进行中（未招募）1 期
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) - the ALIGN Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female subjects between the ages of 18 and 70, inclusive, 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 as a source document by the Sponsor's clinical study monitor or designee at the site monitoring visit to assure the diagnosis is consistent with the information entered into the eCRF. The report will not be removed from the site.
- •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 but are otherwise on standard of care therapy are eligible but will not exceed ~5% of total population randomized. This 5% cap will be managed by the Interactive Response Technology (IRT) system.
- •4. Total urine protein =1 g/day as measured via 24-hour urine collection at a central laboratory collected at Screening.
- •5. eGFR of at least 30 mL/min/1.73 m2 at screening based on the CKD-EPI equation.
- •6. All fertile men and WOCB must be 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.
- •7. Willing and able to provide written informed consent and comply with all study visits and study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 305
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •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. Clinical diagnosis of nephrotic syndrome.
- •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 systemic corticosteroids (e.g. prednisone, prednisolone, 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.
- •8. Confirmed blood pressure >150 mmHg systolic or >90 mmHg diastolic based on one or more 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 or approved treatment for IgAN (other than a RAS inhibitor) including SGLT2 inhibitors 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, might pose additional risk to the subject by their participation in the study. The Sponsor's Medical Monitor (or designee), if contacted by the investigator, can provide advice for the investigator's consideration.
- •17. History of an alcohol or illicit drug-related disorder within the past 3 years.
研究者
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