Clinical trial
Efficacy and Safety of Tacrolimus in Combination With Anti-CD20 Monoclonal Antibody (Ripertamab) in the Initial Treatment of Patients With Minimal Change Disease: a Multi-center Randomized Controlled Clinical Trial
Name
TAC and ripertamab in MCD
Description
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.
Trial arms
Trial start
2024-05-01
Estimated PCD
2026-04-01
Trial end
2027-04-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Supportive care+Prednisone
Supportive 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.
Arms:
Control Group
Other names:
Control group
Supportive care+Tacrolimus+Ripertamab
Supportive 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.
Arms:
Test group 1
Other names:
Test group 1
Supportive care+Ripertamab
Supportive 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.
Arms:
Test group 2
Other names:
Test group 2
Size
81
Primary endpoint
Relapse rate at 24 months
Up to 24 months after enrollment
Eligibility criteria
Inclusion Criteria:
1. Age 18-80 years old;
2. Primary minimal change disease confirmed by renal biopsy (Initial therapy);
3. 24h-UTP\>3.5g/d or PCR\>3500mg/g, and serum albumin\<30g/L;
4. Agree to participate in the project and sign the informed consent.
Exclusion Criteria:
1. Secondary minimal change disease;
2. eGFR\<60 mL/min/1.73m2;
3. 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;
4. Active bleeding in the gastrointestinal tract;
5. Prior treatment with corticosteroids or other immunosuppressants;
6. HBV, HCV, HIV or other untreated infections, congenital or acquired immunodeficiency diseases;
7. Have been vaccinated with live vaccine in the past four weeks;
8. Serum bilirubin \> 3.6mg/dl for at least 1 month or liver function ≥3 times the upper limit of normal value;
9. Allergic to prednisolone, tacrolimus, or ripertamab;
10. Reluctance to use contraception or plan pregnancy/lactation within 6 months of study completion;
11. Had history of alcohol/drug abuse;
12. Unable to give informed consent.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 81, 'type': 'ESTIMATED'}}
Updated at
2024-05-08
1 organization
2 products
1 indication
Organization
Air Force Military Medical UniversityProduct
PrednisoneIndication
Minimal Change DiseaseProduct
Supportive care