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

NCT06405100 | Not Yet Recruiting Phase 3

• 1 other identifier: TAC and ripertamab in MCD
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Minimal Change Disease

Outcome Measures

Primary Outcomes (1)

• Relapse rate at 24 months

  Relapse: Proteinuria\>3.5g/d or PCR\>3500mg/g after complete remission has been achieved.

  Up to 24 months after enrollment

Secondary Outcomes (5)

• Relapse rate at 12/18 months

  Up to 18 months after enrollment

• Partial or complete remission at 2/6/12/24 months

  Up to 24 months after enrollment

• The time from the start of treatment to achieve complete remission

  Up to 24 months after enrollment

• The time from clinical complete remission to replase

  Up to 24 months after enrollment

• Safety-adverse events

  The time from randomization until the occurrence of such adverse events, up to 24 months

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Supportive care+Prednisolone

Drug: Supportive care+Prednisone

Test group 1

ACTIVE COMPARATOR

Supportive care+Tacrolimus+Ripertamab

Drug: Supportive care+Tacrolimus+Ripertamab

Test group 2

ACTIVE COMPARATOR

Supportive care+Ripertamab

Drug: Supportive care+Ripertamab

Interventions

Supportive care+Prednisone 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.

Also known as: Control group

Control Group

Supportive care+Tacrolimus+Ripertamab 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.

Also known as: Test group 1

Test group 1

Supportive care+Ripertamab 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.

Also known as: Test group 2

Test group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old;
• Primary minimal change disease confirmed by renal biopsy (Initial therapy);
• h-UTP\>3.5g/d or PCR\>3500mg/g, and serum albumin\<30g/L;
• Agree to participate in the project and sign the informed consent.

You may not qualify if:

• Secondary minimal change disease;
• eGFR\<60 mL/min/1.73m2;
• 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;
• Active bleeding in the gastrointestinal tract;
• Prior treatment with corticosteroids or other immunosuppressants;
• HBV, HCV, HIV or other untreated infections, congenital or acquired immunodeficiency diseases;
• Have been vaccinated with live vaccine in the past four weeks;
• Serum bilirubin \> 3.6mg/dl for at least 1 month or liver function ≥3 times the upper limit of normal value;
• Allergic to prednisolone, tacrolimus, or ripertamab;
• Reluctance to use contraception or plan pregnancy/lactation within 6 months of study completion;
• Had history of alcohol/drug abuse;
• Unable to give informed consent.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator
• The Second Affiliated Hospital of Air Force Military Medical University: collaborator
• Shaanxi Provincial People's Hospital: collaborator
• Shaanxi Provincial Hospital of Chinese Medicine: collaborator

MeSH Terms

Conditions

Nephrosis, Lipoid

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

shiren Sun[Author], Doctor

CONTACT

18729387675; 272844142@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: May 4, 2024
• First Posted: May 8, 2024
• Study Start: May 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 8, 2024

Record last verified: 2024-04