Efficacy and Safety of Tacrolimus in Combination With Ripertamab in the Initial Treatment of Patients With MCD

Phase 3

Not yet recruiting

• Conditions: Minimal Change Disease
• Interventions: Drug: Supportive care+Prednisone; Drug: Supportive care+Ripertamab; Drug: Supportive care+Tacrolimus+Ripertamab

• Registration Number: NCT06405100
• Lead Sponsor: Air Force Military Medical University, China

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.

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-05
• Study First Submitted: 2024-05-04
• Study First Submitted QC: 2024-05-04
• Last Update Submitted: 2024-05-04
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08
• Primary Completion: 2026-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Supportive care+Prednisone	Supportive care+Prednisolone
Test group 2	Supportive care+Ripertamab	Supportive care+Ripertamab
Test group 1	Supportive care+Tacrolimus+Ripertamab	Supportive care+Tacrolimus+Ripertamab

Primary Outcome Measures

Name	Time	Method
Relapse rate at 24 months	Up to 24 months after enrollment	Relapse: Proteinuria\>3.5g/d or PCR\>3500mg/g after complete remission has been achieved.

Secondary Outcome Measures

Name	Time	Method
Relapse rate at 12/18 months	Up to 18 months after enrollment	The relapse rates of MCD patients at 12 months and 18 months were observed
The time from the start of treatment to achieve complete remission	Up to 24 months after enrollment	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	Up to 24 months after enrollment
Partial or complete remission at 2/6/12/24 months	Up to 24 months after enrollment	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
Safety-adverse events	The time from randomization until the occurrence of such adverse events, up to 24 months	Creatinine levels doubled from baseline; an increase ≥30% from eGFR baseline; ESRD; adverse events; drug-related adverse events, and abnormal clinical manifestations