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

Air Force Military Medical University of People's Liberation Army

Status and phase: Not yet enrolling; Phase 3

Conditions: Minimal Change Disease

Treatments: Drug: Supportive care+Prednisone; Drug: Supportive care+Ripertamab; Drug: Supportive care+Tacrolimus+Ripertamab

Study type: Interventional

Funder types: Other

Identifiers

NCT06405100

TAC and ripertamab in MCD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 3 patient groups

Control Group

Active Comparator group

Description:

Supportive care+Prednisolone

Treatment:

Drug: Supportive care+Prednisone

Test group 1

Active Comparator group

Description:

Supportive care+Tacrolimus+Ripertamab

Treatment:

Drug: Supportive care+Tacrolimus+Ripertamab

Test group 2

Active Comparator group

Description:

Supportive care+Ripertamab

Treatment:

Drug: Supportive care+Ripertamab