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临床试验/EUCTR2020-004176-18-IT
EUCTR2020-004176-18-IT进行中（未招募）1 期

A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) - AFFINITY Study

CHINOOK THERAPEUTICS, U.S., Inc0 个研究点目标入组 80 人开始时间: 2021年6月8日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
80
研究概览入排标准研究者记录与标识符相似试验

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

  • •Cohort 1 – IgAN
  • •1. 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
  • •2. Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to screening.
  • •3. UPCR = 0.5 and < 1.0 g/g (= 500 mg/g and < 1000 mg/g) based on a central laboratory assessment of first morning void urine collected at screening.
  • •4. eGFR = 30 mL/min/1.73 m2
  • •Cohort 2 – FSGS
  • •5. Biopsy-confirmed FSGS or documentation of a genetic mutation in a podocyte protein associated with FSGS.
  • •6. UPCR >1.5 g/g (> 1500 mg/g) based on a central laboratory assessment of first morning void urine collected at screening.
  • •7. eGFR = 30 mL/min/1.73 m2
  • •8. Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to screening.
  • •9. If receiving systemic corticosteroids or calcineurin inhibitors, dose must be stable for 12 weeks prior to start of study drug and anticipated to remain on a stable dose at least through week 12.
  • •10. Body mass index (BMI) = 40 kg/m2
  • •Cohort 3 – Alport syndrome
  • •11. Diagnosis of Alport syndrome by genetic testing (documented mutation in a gene associated with Alport syndrome, including COL4A3, COL4A4, or X-linked COL4A5 in the subject or a family member). Or patients with a new mutation, that, in the opinion of the Investigator, has significant supporting evidence of Alport syndrome (biopsy, familial genetics, family history & familial biopsy, microscopic hematuria, hearing loss pattern, fleck retinopathy).
  • •12. UPCR > 0.5 g/g (>500 mg/g) based on central laboratory assessment of first morning void urine at screening
  • •13. Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to screening visit
  • •14. eGFR = 30 mL/min/1.73 m2
  • •Cohort 4 – DKD
  • •15. Clinical diagnosis of type 2 diabetes mellitus (T2DM) as per guidelines
  • •16. Diagnosis of DKD, including the presence of the following criteria:
  • •a. UACR = 0.5 g/g (500 mg/g) based on central laboratory assessment of first morning void urine at screening
  • •b. eGFR = 30 mL/min/1.73 m2
  • •17. Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to the screening visit and stable dose of SGLT2 inhibitor for at least 12 weeks prior to screening
  • •18. Age 18 years and older at the time of signing ICF
  • •Pregnancy and Contraception
  • •19. 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
  • •20. 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 76
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 4

排除标准

  • •Medical Conditions
  • •1. Concurrent diagnosis of another cause of CKD or another primary glomerulopathy. Note: hypertensive nephrosclerosis is not exclusionary
  • •2. Clinical suspicion of rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines or clinical suspicion of IgA vasculitis (Henoch-Schonlein Purpura).
  • •3. History of organ transplantation (subjects with history of corneal transplant are not excluded).
  • •4. Known history of congestive heart failure, diastolic dysfunction, or prior hospital admissions for conditions relating to fluid overload such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites.
  • •5. Known history of clinically significant liver disease or transaminase or bilirubin values >2 times the upper limit of normal (ULN) for Cohorts 1-3; for Cohort 4 (DKD), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3XULN (subjects with non alcoholic fatty liver disease/non-alcoholic steatohepatitis will be allowed).
  • •6. Active infection which may warrant systemic treatment
  • •7. Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies)
  • •8. Known active Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive); Subjects with successfully treated hepatitis C can be considered for inclusion into the study upon consultation with the Sponsor’s Medical Monitor (or designee).
  • •9. 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.
  • •10. Any history within 3 months of screening of clinically significant, unstable, or uncontrolled cardiovascular (including myocardial infarction, unstable angina, cardiovascular revascularization procedure, cerebrovascular accident, or transient ischemic attack), 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.
  • •Diagnostic assessments
  • •11. Brain natriuretic peptide (BNP) value of > 200 pg/mL at screening
  • •12. Platelet count <80,000 per µL at screening
  • •13. Hemoglobin below 9 g/dL at screening or prior history of blood transfusion for anemia within 3 months of screening.
  • •14. Confirmed blood pressure >150 mmHg systolic or >95 mmHg diastolic based on a mean of 3 measurements obtained at screening.
  • •15. Serum albumin < 3.0 g/dL for patients in the IgAN, Alport Syndrome, and DKD cohorts.
  • •16. HbA1c > 9.5% in Cohort 4 (DKD), HbA1c > 7.0% in Cohorts 1-3.
  • •Prior/Concomitant Medications
  • •17. Except for Cohort 2 (FSGS), use of systemic immunosuppressant medications including systemic steroids (prednisone or equivalent >10 mg/day for more than 2 weeks within 3 months prior to screening), mycophenolate, azathioprine, cyclosporine, tacrolimus, etc. for more than 2 weeks within the past 3 months prior to screening.
  • •18. Use of rituximab within the past 6 months
  • •19. Use of mineralocorticoid receptor antagonists such as spironolactone/eplerenone within 3 months prior to screening
  • •20. With the exception of DKD (Cohort 4), use of an SGLT2 inhibitor within the past 30 days.
  • •Prior/Concurrent Clinical Study Experience
  • •21. Have received any investigational agent within 1 month (or 5 half-lives of t

研究者

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