ClinicalTrials.gg
RecruitingNCT03501459Updated Aug 28, 2019

Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome

A Phase 3 interventional study of Rituximab in Nephrotic Syndrome, sponsored by National University Health System, Singapore. Recruiting at 1 site in Singapore. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by National University Health System, Singapore · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2020, 5 years 11 months ago, but the record still lists the study as recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
1 Year and older
Sex
All
01

Where this study stands

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

Among 19 studies testing rituximab in Nephrotic Syndrome — 5 open to participants now, 5 under way, 3 of them phase 3. Rituximab · Nephrotic Syndrome.

Planned enrollment
6th of 19
100 · median 80
Started
2008
the only one that year
Phase 3
8 of 19
3 open now
Registered
9th of 19
by date
Lead sponsor
1 of 19
National University Health System, Singapore

Among the 19 studies testing rituximab in Nephrotic Syndrome, this one is the 6th largest by planned enrollment, is the only one that started in 2008, is one of 8 in phase 3, and was the 9th 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

5 of the 19 studies testing rituximab in Nephrotic Syndrome are open now, in 3 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

About rituximab

Rituximab: first FDA approval 1997 (RITUXAN), first EMA approval 1998. What it is approved for, and how studies give it, is on its page →

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 and older · 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.

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02

Study summary

The purpose of this study is to investigate if lymphocyte markers predict response to rituximab among patients with idiopathic nephrotic syndrome

03

Conditions studied

  • Nephrotic Syndrome

Browse trials for

04

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Age 1-18 years old at the time of diagnosis of nephrotic syndrome
  • -dependent (SDNS) or steroid-resistant nephrotic syndrome (SDNS)

Exclusion criteria

Exclusion Criteria:

  • \<60 ml/min per 1.73m2
  • infantile onset of nephrotic syndrome
  • nephrotic syndrome secondary to chronic infections such as , or , systemic lupus erythematosus, Henoch-Schönlein purpura, IgA nephropathy, membranoproliferative glomerulonephritis or membranous nephropathy
  • current or previous therapy for tuberculosis
  • presence of mutations in WT1, NPHS1, NPHS2 and TRPC6.
Terms in these criteria, in plain language(5)

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

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.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Rituximab

    Drug: Rituximab

Interventions

06

What researchers measure

Primary outcomes

  1. Response

    Resolution of proteinuria (urine protein:creatinine \<0.02 g/mmol or urine protein excretion \<0.3 g/1.73m2/day) and ability to wean off prednisolone and calcineurin inhibitor at three months after the last dose of rituximab.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2008, a primary completion of Dec 2020 and a completion of Dec 2025. It does not say whether these dates are actual or estimated.

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

Registered
Apr 10, 2018
First posted
Apr 18, 2018
Start
Jun 2008
Primary completionEst.
Dec 2020
CompletionEst.
Dec 2025
Last update
Aug 28, 2019
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 Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03501459
Lead sponsor
National University Health System, Singapore
Responsible party
Isaac Liu (Professor Yap Hui Kim, National University Health System, Singapore) — Principal investigator
First posted
Apr 18, 2018
Start date
Jun 2008
Primary completion
Dec 2020 (estimated)
Completion
Dec 2025 (estimated)
Last update
Aug 28, 2019

Study contacts

Hui-Kim Yap
Contact
hui_kim_yap@nuhs.edu.sg

Oversight

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

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