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Trial record 46 of 1234 for:    MYCOPHENOLIC ACID

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04531865
Recruitment Status : Not yet recruiting
First Posted : August 31, 2020
Last Update Posted : August 31, 2020
Sponsor:
Collaborators:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Children's Medical Center
Shanghai Children's Hospital
Information provided by (Responsible Party):
Children's Hospital of Fudan University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Frequently Relapsing Nephrotic Syndrome Steroid-Dependent Nephrotic Syndrome Drug: Rituximab Drug: Mycophenolate Mofetil Drug: Placebo tablets matching Mycophenolate Mofetil Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Mycophenolate Mofetil as Maintenance Therapy After Rituximab Treatment in Childhood-onset, Frequently-relapsing or Steroid-dependent Nephrotic Syndrome: a Multicenter Double-blind, Randomized, Placebo-controlled Trial
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : October 1, 2022


Arm Intervention/treatment
Experimental: Rituximab and Mycophenolate Mofetil
First course Course Rituximab at Randomization. Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards.
Drug: Rituximab
Rituximab: 375 mg/m2 intravenously on day 0 and day 7
Other Name: Rituximab Biosimilar HLX01

Drug: Mycophenolate Mofetil
Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards. Dose: 20~30mg/kg/day,BID. Total duration : 8 months.
Other Name: Mycophenolate Mofetil Dispersible tablets(CYCOPIN®)

Placebo Comparator: Rituximab Only
First course Course Rituximab at Randomization. Addition of Maintenance Placebo tablets matching Mycophenolate mofetil from 4 Month onwards.
Drug: Rituximab
Rituximab: 375 mg/m2 intravenously on day 0 and day 7
Other Name: Rituximab Biosimilar HLX01

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.




Primary Outcome Measures :
  1. 1-year relapse-free survival rate [ Time Frame: 1-year period after randomization ]
    The rate of no relapse within 1 year


Secondary Outcome Measures :
  1. The concentration for MPA-area under curve(AUC) [ Time Frame: At 48 weeks ]
    Blood concentrations of mycophenolic acid (MPA)

  2. Proportion of patients with a relapse [ Time Frame: 6 months period after randomization ]
    The proportion of patients with relapse

  3. Time to relapse (days) [ Time Frame: 1-year period after randomization ]
    Number of days from randomization to occurrence of first relapse

  4. B-Cell Recovery Time [ Time Frame: 1-year period after randomization ]
    Time to the first detection of CD19+ cells above 1% of total CD45+ lymphocytes after CD19+ cell depletion

  5. Change in growth velocity [ Time Frame: 1-year period after randomization ]
    The standard deviation scores (SDS) for height at 12th month minus that of randomization.

  6. adverse events [ Time Frame: 1-year period after randomization ]
    It is a binary variable (1/0). The varibale would be setted as "1" if any adverse events occours including early infusion termination, acute infusion reaction Infection, pulmonary fibrosis, encephalopathy, neutropenia. Adverse events graded according to Common Terminology Criteria For Adverse Events (NCI-CTCAE v4.03)



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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531865


Contacts
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Contact: Xu Hong, PhD.MD. +8602164932829 hxu@shmu.edu.cn
Contact: Liu Jialu, PhD.MD. +8613816360839 jialuliu10@fudan.edu.cn

Locations
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China, Shanghai
Children's hospital of Fudan university
Shanghai, Shanghai, China, 200000
China
Shanghai Children's Hospital
Shanghai, China
Shanghai Children's Medical Center
Shanghai, China
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Sponsors and Collaborators
Children's Hospital of Fudan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Children's Medical Center
Shanghai Children's Hospital
Investigators
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Principal Investigator: Xu Hong, PhD.MD. Children's Hospital of Fudan University
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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT04531865    
Other Study ID Numbers: FRSDRM
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mycophenolic Acid
Nephrotic Syndrome
Nephrosis
Syndrome
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action