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Study of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome

ConditionsFRNS/SDNSRipertamab
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-16
SponsorMao Jianhua

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

16 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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ripertamab

    Drug

    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.

  • ripertamab

    Drug

    1 dose of 375mg/m2 BSA ripertamab. 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.

Treatment groups

312 Participants
are divided into 2 treatment groups
Group A: Two doses groupExperimental treatment 1 intervention
Group B: One dose groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Relapse free survival rate

Relapse free survival rate at 1 year

Time frame
1 year

Secondary outcomes

1

Recurrence frequency at 6 and 12 months

Recurrence frequency within 6 months during the study period. Recurrence frequency within 12 months during the study period.

Time frame
1 year
2

Cumulative corticosteroid dose

Total amount of corticosteroids used in 1 year during the study period

Time frame
1 year
3

Median recurrence-free survival

From admission day to 18 months

Time frame
18 months
4

B-cell count

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mao Jianhua

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Sponsor institution

Sinocelltech Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: