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Nephrotic Syndrome in ChildrenPhase 2NCT05843968

Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Nephrotic Syndrome

A Phase 2 study testing Rituximab and Mycophenolate Mofetil in people with Nephrotic Syndrome in Children, run by Children's Hospital of Chongqing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the efficacy and safety of rituximab(RTX) and mycophenolate mofetile(MMF) in the treatment of children with low-dose steroid-dependent nephrotic syndrome(SDNS). Read more about this study

Who is it for?
Ages 3 to 16 years
Conditions the study is for
Nephrotic Syndrome in Children
What is being tested?
Rituximab and Mycophenolate Mofetil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
29 Jan 2023to 1 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children with a definite diagnosis of SDNS are included in the study during relapse treatment.
  • Age 3-16 years.
  • Steroid dependent dose≤0.3mg/kg/day.
  • Cumulative steroid use for ≥6 months.
  • Ability to swallow tablet.
  • Guardians understand the characteristics and personal consequences of clinical trial.
  • Guardians willing to give informed written consent.

Who cannot join

  • Diagnosis of secondary NS, such as secondary to lupus nephritis, hepatitis B-related nephritis, purpura nephritis, etc.
  • Anti-neutrophil cytoplasmic antibodies(ANCA) positive or complement C3 level decreased.
  • Diagnosis of hereditary nephrotic syndrome.
  • Full dose of prednisone (2mg/kg/day, maximum 60mg) are used for 14 days after relapse and urine protein don't turn negative.
  • Estimated glomerular filtration rate (eGFR) <90mL/min per 1.73m^2 at study entry.
  • Those who with a known allergy to Mycophenolate Mofetil and their excipients or to Rituximab and its excipients.
Show all 16Show fewer
  • Those who refuse to participate in the trial.
  • Those who participate other clinical trials.
  • Those who with positive HBV serological markers (HBsAg or/and HBeAg or/and HBcAb), HCV positive patients or patients with abnormal liver function (ALT,AST,or bilirubin>2 or more times the upper limit of the normal range and persistently elevated for 2 weeks).
  • Severe leukopenia (white blood cells<3.0×10^9), severe anemia (hemoglobin<90g/l), and thrombocytopenia (platelets<100×10^9) at study entry.
  • History of pancreatitis or definite gastrointestinal ulcers and/or gastrointestinal bleeding within 6 months.
  • Those who with congenital or acquired immune deficiency, or with active tuberculosis, active CMV and other infections.
  • Those who with other serious physical or mental illnesses.
  • History of malignant tumor within 5 years.
  • Those who with congenital heart disease, arrhythmia, heart failure and other serious cardiovascular diseases.
  • Those who with serious infections requiring intravenous antibiotics.

Trial locations and contacts

1 site in 1 country.

Yang Haiping, Doctor contact

8618983703661

oyhp@hospital.cqmu.edu.cn

China1 site, 1 recruiting

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400014

    Li Qiu, Doctor, 8613708353809, liqiu809@hospital.cqmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Rituximab Versus Mycophenolate Mofetil in Children With Steriod-dependent Nephrotic Syndrome: A Single-center, Randomized Controlled Trial

The goal of this clinical trial is to evaluate the efficacy and safety of rituximab(RTX) and mycophenolate mofetile(MMF) in the treatment of children with low-dose steroid-dependent nephrotic syndrome(SDNS).

Read the detailed description

Idiopathic nephrotic syndrome（INS） is the most common glomerular disease in childhood. Currently, steroids are the primary treatment, but there are significant steroid-related toxicity, such as growth disorders, behavior changes, obesity, Cushing's syndrome, eye disease, osteoporosis, etc.

Both MMF and RTX have been shown to be effective in the treatment of SDNS, and there is a lack of prospective controlled studies to explore the optimal treatment regimen for low-dose SDNS. Therefore, the investigators will conduct a single-center, randomized controlled trial to evaluate the efficacy and safety of twice-daily rituximab(RTX) versus mycophenolate mofetil(MMF) in the treatment of children with low-dose steroid-dependent nephrotic syndrome(SDNS).

After the start of the study, all participants will be screened consecutively and eligible participants will be included in the study. Bias of potential influencing factors will be addressed by inclusion as covariates in the statistical analysis. Independent clinical site monitoring to ensure the safety and integrity of clinical data while patients adhere to the study protocol will focus on source data documentation, strict adherence to data correctness and study procedures, such as randomization and treatment.

Keywords
Nephrotic Syndrome, Rituximab, Mycophenolate Mofetil
Medical subject headings
Nephrotic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called Rituximab Injection

    2 doses of rituximab 375 mg/m^2(maximum 500mg/day) at 6 months intervals.

    Half an hour before rituximab infusion: oral acetaminophen 15mg/kg, oral or intramuscular antihistamine, methylprednisolone 2mg/kg IV. Trimethoprim-sulfamethoxazole should be administered orally from the initiation of rituximab therapy until peripheral-blood B cell recovery to prevent pneumocystis infection.

  • Mycophenolate MofetilDrug

    Also called Mycophenolate Mofetil Dispersible tablets

    Mycophenolate Mofetil 20-30 mg/kg/day BID,then adjust the dosage of drugs(maximum 2g/day) to maintian the concentration for MPA-AUC is 30-50μg.h/ml. Total duration:1year.

    Steroids dose:1.5mg/kg(maximum 40mg) qod for 2 weeks and gradually taper by 0.3 mg/kg every 2 weeks

Study groups in NCT05843968
Study groupRoleWhat they receive
RituximabExperimental2 doses of rituximab 375 mg/m^2 (Maximum 500mg/day)at 6 months intervals
Receives: Drug: Rituximab
Mycophenolate MofetilActive comparatorMMF 20~30mg/kg/day，BID
Receives: Drug: Mycophenolate Mofetil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 12-month relapse-free survival rate

    The rate of no relapse within 12 months.

    Measured: 12 months

Secondary outcomes (13)

  1. 6-month relapse-free survival

    Relapse-free survival within 6 months.

    Measured: 6 months

  2. 6-month relapse-free survival rate

    The rate of no relapse within 6 months.

    Measured: 6 months

  3. 12-month relapse-free survival

    Relapse-free survival within 12 months.

    Measured: 12 months

  4. Proportion of frequent relapses

    The proportion of frequent relapses.Frequent relapsing NS:≥2 relapses per 6 months within 6 months of disease onset or ≥4 relapses per 12 months in any subsequent 12-month period.

    Measured: Months 6,12

  5. Cumulative steroid dosage

    The total dosage of steroid from the beginning to the end of the trial.

    Measured: 12 months

  6. Number of relapses within 0-12,0-6, and 7-12 months

    Number of relapses within 0-6 months,7-12 months, and total within 0-12 months.

    Measured: 12 months

  7. Time of first relapse

    The first time to relapse after patients taking part in this study.

    Measured: 12 months

  8. Adverse event

    It is a binary variable(1/0).The varibale would be setted as "1" if any adverse events occours including obesity, hypertrichosis, psychological disorders,glaucoma,neutropenia,hypogammaglobulinemia, rituximab-related lung injury, fatal hepatitis reactivation, multifocal leukoencephalopathy,severe diarrhea, severe infection. Adverse events graded according to Common Terminology Criteria For Adverse Events (CTCAE v4.0）

    Measured: 12 months

  9. Proportion of participants who discontinued steroids

    Proportion of participants who discontinued steroids at 12 months

    Measured: 12 months

  10. Height standard deviation score(SDS)

    SDS of height at 6 and 12 months, absolute and relative changes in SDS from baseline to 12 months.

    Measured: months 0,6,12

  11. Body mass index(BMI)

    Weight and height will be combined to report BMI in kg/m^2. BMI at 6 and 12 months, absolute and relative changes in BMI from baseline to 12 months.

    Measured: Months 0,6,12

  12. Quality of life score

    The researchers assess the quality of life of the participants useing Pediatric Quality of Life Inventory (PedsQL).

    Measured: Baseline to 12 months

  13. Cost of treatment

    The researchers calculate their cost during the study.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start29 Jan 2023
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05843968
Sponsor's protocol ID
HYang
Status last verified
Apr 2024
First submitted
8 Apr 2023
Last updated
19 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.

    PubMed 39513526

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab and Mycophenolate Mofetil in people with Nephrotic Syndrome in Children, run by Children's Hospital of Chongqing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yang Haiping, Doctor (8618983703661, oyhp@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-month relapse-free survival rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05843968, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.

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