NCT07388810

Brief Summary

This is an open-label randomized controlled trial to evaluate the efficacy and safety of one dose versus two doses of ripertamab in children with frequent relapses or steroid-dependent nephrotic syndrome (FRNS/SDNS).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Feb 2026Feb 2028

First Submitted

Initial submission to the registry

January 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 29, 2026

Last Update Submit

January 29, 2026

Conditions

FRNS/SDNSRipertamab

Outcome Measures

Primary Outcomes (1)

  • Relapse free survival rate

    Relapse free survival rate at 1 year

    1 year

Secondary Outcomes (5)

  • Recurrence frequency at 6 and 12 months

    1 year

  • Cumulative corticosteroid dose

    1 year

  • Median recurrence-free survival

    18 months

  • B-cell count

    18 months

  • The occurrence and severity of adverse events

    18 months

Study Arms (2)

Two doses group

EXPERIMENTAL

2 doses of 375mg/m2 BSA ripertamab at 1-week intervals( within ±1days).

Drug: ripertamab

One dose group

ACTIVE COMPARATOR

1 dose of 375mg/m2 BSA ripertamab.

Drug: ripertamab

Interventions

ripertamabDRUG

2 doses of 375mg/m2 BSA ripertamab at 1-week intervals( within ±1days). At the meantime, prednisone is administered at a dose of 1.5 mg/kg/d (maximum 40 mg) on alternate days or at the dose being used every alternate day before randomization. After 2 weeks, the dose is reduced by 0.25 mg/kg every 2 weeks, and the drug is discontinued at 3 months.

Two doses group

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years old and above with FRNS/SDNS
  • Before enrollment, achieved complete remission (urine protein/creatinine ratio (morning urine or 24-hour urine) ≤ 20mg/mmol (0.2mg/mg) or \< 100mg/m2/d, or test strip result negative or trace)
  • Within 2 months before enrollment, did not use levamisole, alkylating agents such as cyclophosphamide, calcineurin inhibitors such as cyclophosphamide and cyclosporine, or mycophenolate mofetil. Within 6 months before enrollment, did not use other CD20 monoclonal antibodies (such as ofatumumab, otuzumab, etc., excluding rituximab)
  • Glomerular filtration rate (eGFR) \> 60ml/min/1.73m2
  • The patient or their guardian agrees to participate in this clinical trial and signs the informed consent form, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the study

You may not qualify if:

  • Known causes (such as systemic lupus erythematosus, IgA nephropathy, other secondary nephrotic syndromes, amyloidosis, malignant tumors, etc.)
  • Known active chronic infections, including tuberculosis, HIV, HBV, HCV, etc.
  • Severe leukopenia (white blood cells \< 3.0×109/L), severe anemia (hemoglobin \< 8.9 g/dl), thrombocytopenia (platelets \< 100×109/L), or liver dysfunction (alanine aminotransferase/aspartate aminotransferase \> 2 times the upper limit of normal)
  • Received live vaccines within 1 month prior to screening
  • Currently participating in other drug clinical trials
  • Other conditions that the investigator deems make the patient unsuitable for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province 310052

Hangzhou, Zhejiang, China

Location

Central Study Contacts

Jianhua Mao, MD

CONTACT

13516819071maojh88@zju.edu.cn

Xuan Gang, MD

CONTACT

15168358586gangxuan90@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 5, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2028

Last Updated

February 5, 2026

Record last verified: 2026-01

Locations

CN(1)