To evaluate the safety and efficacy of ripertamab and its combination with tacrolimus in the initial treatment of MCD to provide a treatment regimen with higher remission rates, lower recurrence rates, and fewer side effects in patients with MCD.
Age 18-80 years old;
Primary minimal change disease confirmed by renal biopsy (Initial therapy);
24h-UTP>3.5g/d or PCR>3500mg/g, and serum albumin<30g/L;
Agree to participate in the project and sign the informed consent.
Secondary minimal change disease;
eGFR<60 mL/min/1.73m2;
Had history of mental disease, dysnoesia, serious cardiovascular and cerebrovascular diseases, pulmonary insufficiency, malignant tumors or other major diseases that are not suitable for clinical experiments;
Active bleeding in the gastrointestinal tract;
Parallel
Supportive care+Prednisone
DrugSupportive care: Control blood pressure:ACEI/ARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise. Induction period: 1mg/kg/day. The maximum dose is not more than 60mg. The duration of adequate prednisone is a minimum of 4 weeks and a maximum of 16 weeks. Maintenance period: A reduction of 5-10mg/wk was initiated after 2 weeks of complete remission and finally discontinued after 6 months of maintenance at 5mg/day.
Supportive care+Tacrolimus+Ripertamab
DrugSupportive care: Control blood pressure:ACEI/ARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise. Tacrolimus：Induction period: 0.05mg/kg/d. It will be given in two doses 12 hours apart. The blood concentration should be up to 5-10ng/ml. Maintenance therapy was initiated two weeks after complete remission; Maintenance period: Reduced to a blood concentration of 3-8ng/ml, and stopped after 6 months of maintenance treatment. Ripertamab: Given twice every two weeks at a dose of 1000mg. 1000mg is added at 6 months.
Supportive care+Ripertamab
DrugSupportive care: Control blood pressure:ACEI/ARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise. Ripertamab: Given twice every two weeks at a dose of 1000mg. 1000mg is added at 6 months.
Relapse rate at 24 months
Relapse: Proteinuria\>3.5g/d or PCR\>3500mg/g after complete remission has been achieved.
Relapse rate at 12/18 months
The relapse rates of MCD patients at 12 months and 18 months were observed
Partial or complete remission at 2/6/12/24 months
Partial remission: Reduction of proteinuria to 0.3-3.5g/d, or PCR 300-3500mg/g and a decrease \>50% from baseline Complete remission: Reduction of proteinuria to \<0.3g/d or PCR\<300mg/g
The time from the start of treatment to achieve complete remission
The time it takes for patients with MCD to reach a state of complete remission needs to be observed
The time from clinical complete remission to replase
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Air Force Military Medical University, China
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University
Collaborator
The Second Affiliated Hospital of Air Force Military Medical University
Collaborator
Shaanxi Provincial People's Hospital
Collaborator
Shaanxi Provincial Hospital of Chinese Medicine
Collaborator
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