ClinicalTrials.gg
RecruitingNCT06530004Updated Jul 31, 2024

Clinical Follow-up Study of Rituximab in the Treatment of Nephrotic Syndrome in Children

An observational study in Nephrotic Syndrome, Rituximab and Children, sponsored by The First Affiliated Hospital of Xiamen University. Recruiting at 1 site in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by The First Affiliated Hospital of Xiamen University · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Mar 2020; still recruiting 6 years 8 months later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
50
Ages
1 Year to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 34 studies in Nephrotic Syndrome with a site in China — 19 open to participants now, 21 under way, 5 of them phase 3. Nephrotic Syndrome · China.

Started
2020
the only one that year
Observational
9 of 34
4 open now
Primary completion
2026-03
later than 3 of 20 live
Registered
22nd of 34
by date

Among the 34 studies in Nephrotic Syndrome with a site in China, this one is the only one that started in 2020, is one of 9 observational ones, reaches primary completion later than 3 of the 20 other live ones, and was the 22nd registered.

Nephrotic Syndrome

191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.

Browse Nephrotic Syndrome studies →

Open to participants now

19 of the 34 studies in Nephrotic Syndrome with a site in China are open now. Recruiting first, the newest first:

13 more — sign in →

All 19 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 50 Nephrotic Syndrome studies recruiting now, 23 (46%) set no upper age limit and 22 (44%) stop at 75 or younger; 37 take children under 18; 4 take healthy volunteers.

This study: 1 Year to 18 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 34 studies in Nephrotic Syndrome with a site in China, or all of them as a file.
02

Study summary

This was a retrospective study. Children who were diagnosed with refractory nephrotic syndrome and treated with rituximab (RTX) and followed up for ≥1 year in the Department of Pediatrics, the First Affiliated Hospital of Xiamen University from March 2020 to March 2026 were enrolled. Personal information, past medical history, clinical examination data and follow-up data before and after the use of RTX were extracted from the medical record system. (1) The median relapse-free survival, the number of relapses and the adverse reactions of RTX were compared before and after RTX treatment, and the clinical efficacy and safety of RTX were evaluated. (2) By comparing the annual relapse frequency, reduction and withdrawal of steroids and immunosuppressive agents, B cell reconstitution and adverse drug reactions between prophylactic RTX and post-relapse RTX maintenance regimens; (3) Multivariate analysis of risk factors for recurrence of nephropathy after RTX treatment. (4) growth indicators monitoring patient evaluation and RTX medical economic benefit analysis.

03

Conditions studied

  • Nephrotic Syndrome
  • Rituximab
  • Children
  • Efficacy

Browse trials for

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children who were diagnosed with refractory nephrotic syndrome and treated with rituximab (RTX) and followed up for ≥1 year in the Department of Pediatrics, the First Affiliated Hospital of Xiamen University from March 2020 to March 2026 were enrolled.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children clinically diagnosed with FRNS/SDNS/SRNS with complete clinical data;
  • age \< 18 years old;
  • For the first time using RTX treatment, and used in nephrotic syndrome ease;
  • The follow-up for 1 year or more.

Exclusion criteria

Exclusion Criteria:

  • Congenital or infantile nephrotic syndrome, secondary nephrotic syndrome (such as lupus nephritis, IgA nephropathy, purpura nephritis, nephritis, etc.);
  • Active stage of hepatitis, complicated with severe infection, severe deficiency of immune response, malignant diseases;
  • Estimated (GFR) \<60mL/min/1.73m2.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Sequential prevention group

    According to the situation of B cells to rebuild the preventive use of rituxan, each 375 mg/m2.

    Drug: Rituximab

  • Recurrent sequential group

    In patients with recurrence after the use of rituxan, each 375 mg/m2.

    Drug: Rituximab

Interventions

  • B lymphocyte reconstitution was performed regularly after the administration of rituximab, and 1-4 doses of rituximab were given according to the exhaustion of B cells in children.

06

What researchers measure

Primary outcomes

  1. The median relapse-free survival

    The median relapse-free survival of nephrotic syndrome before and after RTX treatment was compared.

    Time frame: 1 year

  2. Different sequential group curative effect evaluation

    After comparing the preventive RTX and recurrence RTX maintain annual recurrent treatment。

    Time frame: 1 year

Secondary outcomes

  1. Risk factors for renal disease recurrence after RTX treatment.

    Multivariate cox analysis was used to analyze the risk factors of relapse after rituximab treatment in children with nephrotic syndrome by including gender, age of onset of nephrotic syndrome, course of disease before rituximab, history of immunosuppressive therapy, age of rituximab treatment, and maintenance immunosuppressive therapy after rituximab.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2020 (actual). Primary completion is estimated for Mar 2026, 72 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2024
First posted
Jul 31, 2024
StartActual
Mar 1, 2020
Primary completionEst.
Mar 1, 2026
CompletionEst.
Mar 1, 2028
Last update
Jul 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06530004
Responsible party
Bai Haitao, MD (Director, The First Affiliated Hospital of Xiamen University) — Principal investigator
First posted
Jul 31, 2024
Start date
Mar 1, 2020
Primary completion
Mar 1, 2026 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
Jul 31, 2024

Study contacts

Bai HaiTao, doctor
Contact
baihaitao@163.com
13779985336

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion