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Randomized Trial Evaluating Mycophenolate Mofetil in Children With Nephrotic Syndrome After Rituximab Treatment

NCT ID: NCT04531865

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-10-01

Brief Summary

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The aim of this study is to evaluate the efficacy and safety of maintenance Mycophenolate Mofetil following single course of Rituximab in maintaining remission over 12 months among Children with frequently-relapsing or steroid-dependent nephrotic syndrome

Detailed Description

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The results of multiple observational studies and randomized control trials have shown that Rituximab, a chimeric monoclonal antibody against the cluster of differentiation antigen 20 (CD20) antigen on B cells, is safe and effective for children with complicated steroid-dependent/ frequently-relapsing nephrotic syndrome (SDFRNS) without corticosteroid or immunosuppressive therapy. Single rituximab infusion has been shown to be efficacious for 6 to 12 months, the reported median relapse-free period was 9 months. Our previous study found that Mycophenolate mofetil can further improve the sustained remission time.

All patients will be treated with 2 doses of Rituximab 375 mg/m2 iv at time 0 and 7 days. Addition of Maintenance Mycophenolate Mofetil or placebo from 4 Month onwards. The expected duration of the follow-up is 12 months, consisting of 12 visits.

Conditions

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Frequently Relapsing Nephrotic Syndrome Steroid-Dependent Nephrotic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rituximab and Mycophenolate Mofetil

First course Course Rituximab at Randomization. Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards.

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

Rituximab: 375 mg/m2 intravenously on day 0 and day 7

Mycophenolate Mofetil

Intervention Type DRUG

Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards. Dose: 20\~30mg/kg/day，BID. Total duration : 8 months.

Rituximab Only

First course Course Rituximab at Randomization. Addition of Maintenance Placebo tablets matching Mycophenolate mofetil from 4 Month onwards.

Group Type PLACEBO_COMPARATOR

Rituximab

Intervention Type DRUG

Rituximab: 375 mg/m2 intravenously on day 0 and day 7

Placebo tablets matching Mycophenolate Mofetil

Intervention Type DRUG

Addition of Maintenance Placebo tablets matching Mycophenolate Mofetil from 4 Month onwards. Dose: 20\~30mg/kg/day，BID. Total duration : 8 months.

Interventions

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Rituximab

Rituximab: 375 mg/m2 intravenously on day 0 and day 7

Intervention Type DRUG

Mycophenolate Mofetil

Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards. Dose: 20\~30mg/kg/day，BID. Total duration : 8 months.

Intervention Type DRUG

Placebo tablets matching Mycophenolate Mofetil

Addition of Maintenance Placebo tablets matching Mycophenolate Mofetil from 4 Month onwards. Dose: 20\~30mg/kg/day，BID. Total duration : 8 months.

Intervention Type DRUG

Other Intervention Names

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Rituximab Biosimilar HLX01 Mycophenolate Mofetil Dispersible tablets（CYCOPIN®）

Eligibility Criteria

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Inclusion Criteria

1. Children between 1 and 16 years with Frequently-relapsing or Steroid-dependent Nephrotic Syndrome
2. Estimated glomerular filtration rate (eGFR) ≥90 ml/min per 1.73 m2 at study entry.
3. Remission at study entry
4. Patients in whom ≥5 CD20-positive cells/μL are observed in the peripheral blood.
5. Parents willing to give informed written and audiovisual consent.

Exclusion Criteria

1. Patients who have been diagnosed with nephritic- NS, such as immunoglobulin A(IgA) nephropathy, prior to assignment or in whom secondary NS is suspected.
2. Patients showing one of the following abnormal clinical laboratory values:

1\) Leukocytes \< 3000/μL. 2) Neutrophils \< 1500/μL. 3) Platelets \< 50,000/μL. 4) Alanine aminotransferase (ALT) \> 2.5× upper limit of normal value. 5) Aspartate aminotransferase (AST) \> 2.5× upper limit of normal value. 6) Positive for hepatitis B surface (HBs) antigen, HBs antibody, hepatitis B core (HBc) antibody, or hepatitis C virus (HCV) antibody. 7) Positive for HIV antibody.

3\. Patients meeting one of the following infection criteria:

1\) Presence or history of severe infections within 6 months prior to assignment.2) Presence or history of opportunistic infections within 6 months prior to assignment.3) Presence of active tuberculosis.4) Patients with a history of tuberculosis or in whom tuberculosis is suspected.5) Presence or history of active hepatitis B or hepatitis C or hepatitis B virus carrier.6) Presence of human immunodeficiency virus (HIV) infection.

4\. Presence or history of angina pectoris, cardiac failure, myocardial infarction, or serious arrhythmia (findings observed under Grade 4 of the Common Terminology Criteria for Adverse Events (CTCAE)).

5\. Presence or history of autoimmune diseases or vascular purpura.

6\. Presence or history of malignant tumor.

7\. History of organ transplantation.

8\. History of drug allergies to methylprednisolone, acetaminophen, cetirizine, mycophenolate mofetil,rituximab, or any of the above drugs

9\. Uncontrollable hypertension.

10\. Having received a live vaccine within 4 weeks prior to enrollment.

11\. Patients who do not agree with contraception during the study period.

12\. Judged inappropriate for this study by the treating or study physicians.
Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Shanghai Children's Medical Center

OTHER

Sponsor Role collaborator

Shanghai Children's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xu Hong, PhD.MD.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

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Children's hospital of Fudan university

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Children's Hospital

Shanghai, , China

Site Status

Shanghai Children's Medical Center

Shanghai, , China

Site Status

Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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FRSDRM

Identifier Type: -

Identifier Source: org_study_id