CTIS2024-513228-40-00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) - CHK01-02
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 224
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Cohort 1 – IgAN: 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, Cohorts 2 and 5 – FSGS: Body mass index (BMI) = 40 kg/m2, Cohort 2b: Subjects in cohort 2 who have completed treatment with 0.75mg atrasentan for at least 12 weeks, Cohort 2b: Subjects have tolerated treatment with 0.75mg atrasentan and meet criteria for dose escalation as defined in section 4.1 of the protocol., Cohort 2b: Subjects who have completed an EoS visit in cohort 2 may be eligible to enroll in Cohort 2b if less than 90 days have elapsed since the EoS visit and if they meet all entry criteria except UPCR., Cohort 3 – Alport syndrome: 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 subjects that, in the opinion of the Investigator, have strong clinical evidence of Alport syndrome (biopsy, familial genetics, family history & familial biopsy, microscopic hematuria, hearing loss pattern, fleck retinopathy)., Cohort 3 – Alport syndrome: UPCR > 0.5 g/g (>500 mg/g) based on central laboratory assessment of first morning void urine at screening, Cohort 3 – Alport syndrome: Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to screening visit, Cohort 3 – Alport syndrome: eGFR = 30 mL/min/1.73 m2, Cohort 4 – DKD: Clinical diagnosis of type 2 diabetes mellitus (T2DM) as per guidelines, Cohort 4 – DKD: 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 = 45 mL/min/1.73 m2, Cohort 1 – IgAN: Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to screening., Cohort 4 – DKD: 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, Age: For Cohorts 1-3 and 5 (IgAN, FSGS, Alport syndrome, respectively): age 18 years and older at the time of signing ICF., Age: For Cohort 4 (DKD): age between 18 to 70 years old, inclusive, at the time of signing ICF., Pregnancy and Contraception: All fertile men and WOCBP 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., Informed Consent: Willing and able to provide written informed consent and comply with all study visits and study procedures., Cohort 1 – IgAN: UPCR = 0.5 and < 1.0 g/g (= 500 mg/g and < 1000 mg/g; =56.5 mg/mmol and <113 mg/mmol) based on a central laboratory assessment of first morning void urine collected at screening, or a central laboratory assessment from another Chinook clinical trial completed within 28 days of the screening visit with Sponsor's Medical Monitor (or designee) approval., Cohort 1 – IgAN: eGFR = 30 mL/min/1.73 m2, Cohorts 2 and 5 – FSGS: Biopsy-confirmed FSGS or documentation of a genetic mutation in a podocyte protein associated with FSGS. This includes seco
排除标准
- •Concurrent diagnosis of another cause of CKD or another primary glomerulopathy. Note: hypertensive nephrosclerosis is not exclusionary, 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., Brain natriuretic peptide (BNP) value of > 200 pg/mL at screening, Platelet count <80,000 per µL at screening, Hemoglobin below 9 g/dL at screening or prior history of blood transfusion for anemia within 3 months of screening., Confirmed blood pressure >150 mmHg systolic or >95 mmHg diastolic based on a mean of 3 measurements obtained at screening., Current diagnosis of nephrotic syndrome., HbA1c > 9.5% in Cohort 4 (DKD), HbA1c > 7.0% in Cohorts 1-3., Except for Cohorts 2 and 5 (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., Use of rituximab within the past 6 months prior to screening, Use of cyclosporine within the past 1 week prior to screening, Clinical suspicion of rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines or clinical suspicion of IgA vasculitis (Henoch-Schonlein Purpura)., With the exception of DKD (Cohort 4), use of an SGLT2 inhibitor within the past 30 days., Have received any investigational agent within 1 month (or 5 halflives 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., History of an alcohol or illicit drug-related disorder within the past 3 years., Pregnancy, breast feeding, or intent to become pregnant during the study period and at least 1 month afterward for females., Intent to father a child or donate sperm during the study period and at least 1 month afterward for males., History of organ transplantation (subjects with history of corneal transplant are not excluded)., 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 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., 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)., Active infection which may warrant systemic treatment, Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies), Known active Hepatitis B (defin
研究者
相似试验
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)Proteinuric glomerular diseases, including: Immunoglobulin A nephropathy (IgAN) (with UPCR 0.5 to <1.0 g/g)Focal segmental glomerulosclerosis (FSGS)Alport SyndromeDiabetes kidney disease (DKD) (as add-on to RAS and sodium glucose co-transporter 2 [SGLT2] inhibitors)EUCTR2020-004176-18-ITCHINOOK THERAPEUTICS, U.S., Inc80
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)Proteinuric glomerular diseases, including:Immunoglobulin A nephropathy (IgAN) (with UPCR 0.5 to <1.0 g/g)Focal segmental glomerulosclerosis (FSGS)Alport SyndromeDiabetes kidney disease (DKD) (as add-on to RAS and sodium glucose co-transporter 2 [SGLT2] inhibitors)EUCTR2020-004176-18-ESChinook Therapeutics U.S., Inc.80
进行中（未招募）
1 期
A study of transarterial chemoembolization (TACE) in combination with nivolumab for liver cell cancerintermediate stage hepatocellular carcinoma (HCC)MedDRA version: 21.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10049010Term: Carcinoma hepatocellularSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10077738Term: Hepatocellular carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-003553-42-DEAIO-Studien-gGmbH49
进行中（未招募）
不适用
A Phase 3, Randomized, Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine for the Treatment of ErbB-2-Positive Locally Advanced or Metastatic Breast Cancer - NDEUCTR2008-005425-11-ITWyeth Research Division of Wyeth Pharmaceutical Inc.1,283
进行中（未招募）
不适用
A Study of Abiraterone Acetate Plus Prednisone With or Without Exemestane in Postmenopausal Women With Estrogen Receptor-Positive (ER+) Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapymetastatic brest cancerMedDRA version: 15.0Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-000621-80-ITJANSSEN-CILAG INTERNATIONAL N.V.300