EUCTR2021-004795-34-ES进行中（未招募）1 期
A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients with IgA Nephropathy - Safety and Efficacy of AT-1501 in Patients with IgA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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
- •Inclusion Criteria: Patients are eligible for the study if they meet all of the following criteria at the time of Screening: 1. Able to understand the key components of the study as described in the written ICF, and are willing and able to provide written informed consent; 2. Male or female = 18 years of age; 3. Biopsy proven IgAN (regardless of how long before Screening the biopsy was performed to make the diagnosis); 4. Urine protein = 0.75g/24 hours at Screening despite optimization with ACE inhibitors or angiotensin receptor blockers (ARB); 5. eGFR = 45 mL/min per 1.73 m2 OR eGFR < 45 mL/min per 1.73 m2 and = 30 mL/min per 1.73 m2.with a kidney biopsy within 2 years of Screening showing < 50% tubulointerstitial fibrosis. 6. Willing and able to comply with the study requirements, including prohibited concomitant medication restrictions; 7. Agree not to participate in another interventional study while participating in this study; 8. If female, is surgically sterile or 12 months postmenopausal. Women of childbearing potential may be enrolled if a serum pregnancy test is negative at Screening/Baseline. Women of childbearing potential and men with partners who are of childbearing potential must agree to use highly effective methods of contraception from Screening, through the EoS Visit. Contraception use must continue for 90 days after the last administration of the study drug. Examples of acceptable methods of contraception which must be used together are described in Table 3. 9. If male, agrees to use a medically accepted highly effective method of contraception and agrees to use this method for 90 days after last administration of the study drug; and agrees to not donate sperm for 90 days after last administration of the study drug; 10. If eligible for COVID-19 vaccination in their jurisdiction per local guidelines, have received a complete COVID-19 immunization schedule at least 30 days prior to Screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •Exclusion Criteria: Patients are excluded from the study if any of the following criteria apply: 1. Any secondary IgAN as defined by the Investigator; 2. Patients who have undergone a kidney transplant; 3. Current extrarenal involvement (skin, joints, gastrointestinal tract) suggestive of a diagnosis of IgA vasculitis; prior diagnosis of IgA vasculitis is not exclusionary; 4. Any history of kidney disease other than IgAN; 5. Any history of diabetes (Type 1 or Type 2); 6. Seated blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic) at the Screening Visit. Patients must be on a stable dose and regimen of an ACE inhibitor or ARB for at least 90 days. If necessary, the medication may be adjusted to control for hypertension and hypotension; 7. Clinically significant abnormal ECG at Screening; 8. Thrombocytopenia (platelets < 75,000 per mm3), leukopenia (WBC < 4,000 per µL) or anemia (hemoglobin < 8 g/dL) at Screening; 9. Significant liver disease, defined as having elevated aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels greater than 2 times the upper limit of normal (ULN), per the central laboratory; 10. Pregnancy or breastfeeding; 11. History of a TE event, known hypercoagulable state, or condition requiring long-term anticoagulation; 12. Current malignancy or a history of malignancy (within the past 5 years), except nonmetastatic basal or squamous cell carcinoma of the skin that has been treated successfully; 13. Current or history of active tuberculosis infection except if there is a documented bacille Calmette-Guérin (BCG) vaccination and a negative chest x-ray. Laboratory evidence of infection (positive purified protein derivative or QuantiFERON-TB Gold) in the absence of clinical infection is exclusionary unless the patient has completed treatment. 14. Active infection with HIV, hepatitis C (HCV), or hepatitis B (HBV); 15. Recipient has a positive polymerase chain reaction (PCR) or antigen test for SARS CoV-2 at Screening; 16. Previous treatment with AT-1501 or any other anti-CD40LG or anti-CD40 therapy; 17. Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day; 18. Treatment with an immunologic biologic compound (i.e., tumor necrosis factor inhibitors, [e.g., etanercept, adalimumab], IV immunoglobulin) within 90 days of Screening; 19. Treatment with corticosteroids, including budesonide, immunomodulators (e.g., thiopurines, calcineurin inhibitors), or experimental agents for IgAN within 30 days of Screening; 20. Menopausal hormone replacement therapies containing estrogen therapy alone (> 30 µg/day); 21. Concurrent participation in another interventional study or treatment with an investigational drug up to 30 days or 5 elimination half-lives (depending on medication) whichever is longer prior to Screening; 22. Any form of substance abuse, psychiatric disorder, or a condition that, in the opinion of the Investigator, could invalidate communication with the Investigator; 23. History of any other acute or chronic medical condition or pre-planned medical/surgical procedure that, in the opinion of the Investigator, would compromise the safety of the patient or the integrity of study results; 24. Unlikely to comply with the visits scheduled in the protocol, in the opinion of the Investigator.
研究者
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