Clinical trial NCT06405100: Efficacy and Safety of Tacrolimus in Combination With Ripertamab in the Initial Treatment of Patients With MCD
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Minimal Change Disease
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital Xi'an Jiaotong University
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: The Second Affiliated Hospital of Air Force Military Medical University
name: Shaanxi Provincial People's Hospital
name: Shaanxi Provincial Hospital of Chinese Medicine
First posted: 2024-05-08
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Minimal change disease is the third most common primary kidney disease in adults with idiopathic nephrotic syndrome. The pathological features of the disease are no or only slight changes under light microscope, and the foot process fusion under electron microscope. The KDIGO guidelines recommend oral adequate doses of glucocorticoids as the initial treatment for adults with MCD. However, 48%-76% of patients relapse after tapering or gradual discontinuation of the drug, requiring a high cumulative dose of glucocorticoids. As the cumulative dose of glucocorticoids increases, the potential for side effects increases. In addition, 10% to 30% of patients frequently relapse, and 15% to 30% of these are steroid dependent. Therefore, the clinical goals for patients with MCD are to achieve early remission of proteinuria, reduce hormonal side effects, and more importantly, prevent the recurrence of proteinuria.

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.

Primary outcomes:
measure: Relapse rate at 24 months
timeFrame: Up to 24 months after enrollment
Secondary outcomes:
measure: Relapse rate at 12/18 months
timeFrame: Up to 18 months after enrollment
measure: Partial or complete remission at 2/6/12/24 months
timeFrame: Up to 24 months after enrollment
measure: The time from the start of treatment to achieve complete remission
timeFrame: Up to 24 months after enrollment
measure: The time from clinical complete remission to replase
timeFrame: Up to 24 months after enrollment
measure: Safety-adverse events
timeFrame: The time from randomization until the occurrence of such adverse events, up to 24 months
Other outcomes:
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