ClinicalTrials.gg
Not yet recruitingNCT07811557TRANSCRIPTUpdated Sep 10, 2026

Single-cell RNA Sequencing (scRNA-seq) to Investigate the Mechanisms Underlying the Induction of Regulatory T Cells in Patients With Extramembranous Glomerulonephritis Treated With Rituximab

An interventional study of Peripheral blood immune-cell profiling by single-cell RNA sequencing and in vitro pathway modulation assays in Membranous Nephropathy, Membranous Nephropathy - PLA2R Induced and Nephrotic Syndrome, sponsored by Centre Hospitalier Universitaire de Nice. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

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

Among 17 studies in Glomerulonephritis, Membranous with a site in France — 7 open to participants now, 8 under way, 2 of them phase 3. Glomerulonephritis, Membranous · France.

Planned enrollment
12th of 15
12 · median 43
Started
2026
with 2 others
No phase
4 of 17
2 open now
Registered
17th of 17
by date
Lead sponsor
7 of 17
Centre Hospitalier Universitaire de Nice

Among the 17 studies in Glomerulonephritis, Membranous with a site in France, this one is the 12th largest by planned enrollment of the 15 interventional ones that give a count, is one of 3 that started in 2026, is one of 4 with no phase, and was the 17th registered.

Glomerulonephritis, Membranous

144 studies on the registry are indexed under Glomerulonephritis, Membranous; 58 are open to participants now.

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Open to participants now

7 of the 17 studies in Glomerulonephritis, Membranous with a site in France are open now. Recruiting first, the newest first:

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All 7 open studies →

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

Who these studies take

Of the 40 Glomerulonephritis, Membranous studies recruiting now, 14 (35%) set no upper age limit and 13 (33%) stop at 75 or younger; 7 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

Membranous nephropathy is a rare autoimmune kidney disease in which autoantibodies, most commonly anti-PLA2R1 antibodies, target podocyte antigens and may cause nephrotic syndrome. Rituximab is used in routine care to deplete B cells and reduce pathogenic autoantibodies, but its effects are not limited to B-cell depletion. Previous work suggests that rituximab may also promote regulatory T-cell (Treg) responses, and higher Treg levels after treatment have been associated with clinical remission.

TRANSCRIPT is a prospective, single-center, pilot mechanistic study in 12 adult patients with active anti-PLA2R1-positive membranous nephropathy who have an indication for rituximab as part of routine care. Participants will receive rituximab according to usual clinical practice (1 g on Day 0 and 1 g on Day 15). Additional blood samples will be collected at Day 0 and Month 6 to isolate peripheral immune cells. Single-cell RNA sequencing will be used to identify transcriptional changes, signaling pathways, and intercellular communication networks associated with rituximab-induced Treg induction. In vitro assays will then test modulators of the candidate pathways identified by sequencing.

The study hypothesis is that rituximab modulates immune-cell signaling and communication pathways that contribute to the induction of regulatory T cells in patients with membranous nephropathy.

03

Conditions studied

  • Membranous Nephropathy
  • Membranous Nephropathy - PLA2R Induced
  • Nephrotic Syndrome
04

Who can participate

Ages eligible
18 Years 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

  1. Signed .
  2. Anti-PLA2R1-positive membranous nephropathy.
  3. Active nephrotic syndrome, defined as urinary protein/creatinine ratio >3.5 g/g and serum albumin \<30 g/L.
  4. Indication for rituximab treatment as part of routine care.
  5. Estimated calculated using the CKD-EPI equation >30 mL/min/1.73 m2.

Exclusion criteria

Exclusion Criteria:

  1. Lack of affiliation to the French social security system.
  2. Vulnerable person, including minors, adults under guardianship or curatorship, pregnant women, persons deprived of liberty, or persons who do not master the French language.
  3. treatment received within the previous 6 months.
  4. Breastfeeding.
  5. Absence of effective , when applicable.
  6. Premature discontinuation before administration of both rituximab infusions.
  7. Voluntary withdrawal of or objection to the use of study data or biological samples.
Terms in these criteria, in plain language(4)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Other
    Rituximab-treated anti-PLA2R1-positive membranous nephropathy patients

    Other: Peripheral blood immune-cell profiling by single-cell RNA sequencing and in vitro pathway modulation assays

Interventions

  • OtherPeripheral blood immune-cell profiling by single-cell RNA sequencing and in vitro pathway modulation assays

    Participants with active anti-PLA2R1-positive membranous nephropathy and a routine-care indication for rituximab will undergo two additional research blood collections: one at Day 0 before or on the day of the first rituximab infusion, and one at Month 6. Peripheral blood mononuclear cells will be isolated, cryopreserved, and analyzed by single-cell RNA sequencing. Candidate signaling pathways associated with regulatory T-cell induction will be assessed in vitro using pathway activators or inhibitors and flow cytometry-based Treg measurement. Rituximab itself is administered as part of usual care at 1 g on Day 0 and 1 g on Day 15, not as an investigational treatment assigned by the study.

06

What researchers measure

Primary outcomes

  1. Change in regulatory T-cell induction and rituximab-modulated immune signaling pathways from Day 0 to Month 6

    Regulatory T-cell induction will be assessed by single-cell RNA sequencing of peripheral immune cells collected from 12 rituximab-treated participants at Day 0 and Month 6. The analysis will identify differentially expressed genes and their fold changes within immune-cell subpopulations, including Treg cells and partner immune-cell populations. It will also identify the main signaling and cell-cell communication pathways that are deregulated or modulated between Day 0 and Month 6.

    Time frame: Day 0 to Month 6

Secondary outcomes

  1. In vitro induction of regulatory T cells by modulators of rituximab-associated signaling pathways

    Candidate pathways identified by single-cell RNA sequencing will be tested in vitro using peripheral blood mononuclear cells collected at Day 0. Cells will be exposed to pathway activators or inhibitors, and the capacity to induce regulatory T cells will be measured by flow cytometry using markers including CD45, CD3, CD4, CD25 and Foxp3.

    Time frame: After completion of sequencing analyses; in vitro exposure for approximately 24 hours

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided — Not planned yet

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Oct 2029, 36 months later.

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

Registered
Sep 3, 2026
First posted
Sep 10, 2026
StartEst.
Oct 31, 2026
Primary completionEst.
Oct 31, 2029
CompletionEst.
Oct 31, 2029
Last update
Sep 10, 2026
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 Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07811557
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Oct 31, 2029 (estimated)
Completion
Oct 31, 2029 (estimated)
Last update
Sep 10, 2026

Study contacts

Barbara SEITZ-POLSKI, MD, PhD, Professor
Contact
drc@chu-nice.fr
+33 4 92 03 40 11
Céline FERNANDEZ
Contact
fernandez.c3@chu-nice.fr
+33 4 92 03 88 28

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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