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

NCT ID: NCT06405100

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2027-04-30

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.

Conditions

Minimal Change Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

Supportive care+Prednisolone

Group Type: ACTIVE_COMPARATOR

Supportive care+Prednisone

Intervention Type: DRUG

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.

Test group 1

Supportive care+Tacrolimus+Ripertamab

Group Type: ACTIVE_COMPARATOR

Supportive care+Tacrolimus+Ripertamab

Intervention Type: DRUG

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.

Test group 2

Supportive care+Ripertamab

Group Type: ACTIVE_COMPARATOR

Supportive care+Ripertamab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Control group; Test group 1; Test group 2

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Air Force Military Medical University

UNKNOWN

Sponsor Role: collaborator

Shaanxi Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Shaanxi Provincial Hospital of Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Shiren sun

Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

shiren Sun[Author], Doctor

Role: CONTACT

272844142@qq.com

18729387675

Other Identifiers

TAC and ripertamab in MCD

Identifier Type: -

Identifier Source: org_study_id