chronic kidney disease, CKD
Conditions
Interventions
Amitinivir tablets 50mg group:Amitinivir tablets 50mg qd
Amitinivir tablets 25mg group:Amitinivir tablets 25mg qd
Amitinivir tablets 12.5mg group:Amitinivir tablets 12.5mg qd
Placebo Group:Placebo
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age at the time of signing the informed consent form is between 18 and 80 years old, with no gender restrictions; 2.Chronic kidney disease patients who have not received dialysis treatment within 6 months have baseline eGFR >= 15mL/min/1.73m^2 and= 20%, a third measurement is required and the average value is calculated using the closest two values; 3.Random urine UACR >= 200 mg/g and= 2.0mg/L and= 2.0mg/L; 5.Prior to screening, receive treatment with angiotensin converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) at the maximum tolerated daily dose (MTLDD) considered by the researcher (not exceeding the dosage range indicated in the instructions) for at least 4 weeks, and maintain a stable dose for at least 4 weeks prior to randomization; 6.Male and female patients with fertility must agree to use effective contraceptive measures throughout the entire study period and for at least 3 months after the last dose; 7.Women with fertility must have a negative serum pregnancy test during screening; 8.Willing and able to cooperate with all research procedures; 9.Willing and able to sign a written informed consent form;
Exclusion criteria
Exclusion criteria: 1.There is clinical evidence or suspicion of active infection; 2.Within the 6 months prior to the screening visit, there have been severe infections or at least 2 severe infections within the 18 months prior to the screening visit; 3.History of gastrointestinal ulcer or perforation within the 12 months prior to the screening visit; 4.History of active diverticulitis, active inflammatory bowel disease, or gastrointestinal abscess within the 12 months prior to the screening visit; 5.History of gastrointestinal bleeding requiring hospitalization and/or blood transfusion within the 6 months prior to the screening visit; 6.New York Heart Association Grade III/IV congestive heart failure and/or hospitalization due to worsening heart failure within 6 months prior to screening visit; 7.Screening for acute coronary syndrome, stroke, transient ischemic attack or other thromboembolic events, as well as vascular reconstruction surgery within the 6 months prior to the visit; 8.Having undergone major surgery or endoscopic procedures within the 6 months prior to the screening visit; 9.Uncontrolled hypertension (defined as an average systolic blood pressure greater than 160mmHg or an average diastolic blood pressure greater than 100mmHg during screening); 10.History of bone marrow or solid organ transplantation or expected to receive organ transplantation during the study period; 11.History of liver cirrhosis; 12.Malignant tumors that have received active treatment or are in the active stage within one year prior to the screening visit, except for successfully cured non metastatic basal cell carcinoma or squamous cell carcinoma (skin cancer) and/or cervical carcinoma in situ; 13.Expected to require blood transfusion within 12 weeks after randomization; 14.Plan to undergo coronary revascularization (PCI or CABG) or any other major surgery within 12 weeks after randomization; 15.Known to be allergic to the investigational drug or any of its components; 16.During the screening period, the absolute value of neutrophils is less than 2.0 × 10^9/L or the platelet count is less than 100 × 10^9/L; 17.During the screening period, alanine aminotransferase or aspartate aminotransferase>2.5 times the upper limit of normal (ULN); 18.Suspected active tuberculosis patients based on medical history or tuberculosis screening; 19.Confirmation of Treponema pallidum or human immunodeficiency virus infection through serological testing during screening; 20.During screening, hepatitis B or C was confirmed by serological tests (such as positive hepatitis B surface antigen or hepatitis C antibody); 21.Received experimental drug treatment within 30 days prior to the screening visit; 22.Screening: Those who have received live vaccine injections or plan to receive live vaccine products during the study drug treatment period within the past 3 months prior to the visit. 23.Plan to receive any experimental drugs or exclude drug treatment during the study drug treatment period or safety follow-up period; 24.Long term use of systemic corticosteroids and/or immunosuppressants during the screening period or expected use of such drugs during the study drug treatment; 25.Those who have received biologics (including biologics targeting B cells, T cells, TNF, IL-6, etc.) within the 6 months prior to the screening visit or plan to receive such drugs during the study drug treatment period; 26.Use systemic antibiotics, systemic antiviral drugs, or systemic antifungal drugs during the screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hs-CRP; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine albumin/creatinine ratio;Serum uric acid;Cystatin C;AST (Aspartate Transaminase);Interferon alpha (IFN-a);Blood routine;Interferon beta (IFN-ß);TNF-a;Alanine aminotransferase;Serum creatinine;IL-1ß;Blood nitrogen;IL-6; | — |
Countries
China
Contacts
Public ContactXiaoyan Zhang
Zhongshan Hospital, Fudan University
Outcome results
None listed