ClinicalTrials.gg
Not yet recruitingNCT06315504Updated Mar 19, 2024

Circulating Factors in Nephrotic Syndrome

An observational study in Nephrotic Syndrome, Membranous Nephropathy and Minimal Change Disease, sponsored by Iain Bressendorff. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Iain Bressendorff · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
104
Ages
18 Years and older
Sex
All
01

Study summary

A prospective observational study to investigate the treatment-associated changes of circulating factors associated with glomerular diseases among patients with de novo nephrotic syndrome admitted to hospital for a kidney biopsy.

02

Conditions studied

  • Nephrotic Syndrome
  • Membranous Nephropathy
  • Minimal Change Disease
  • Primary Focal Segmental Glomerulosclerosis
03

In context

Nephrotic Syndrome

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

This study's planned enrollment of 104 is below the median of 125 across 59 observational studies indexed under Nephrotic Syndrome.

Browse Nephrotic Syndrome studies →

Lead sponsor

Iain Bressendorff is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

De novo nephrotic syndrome admitted to hospital for a clinically indicated kidney biopsy.

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 ≥ 18 years
  • Plasma albumin \< 36 g/L
  • Urine protein >3.5 g/day or urine protein/creatinine-ratio (UPCR) > 3.5 or urine albumin/creatinine-ratio (UACR) >2200 mg/g
  • Planned kidney
  • Able to give written

Exclusion criteria

Exclusion Criteria:

  • Kidney transplant recipient
  • Previously undergone a kidney
  • Unable to understand written information in Danish
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.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
104 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with de novo nephrotic syndrome

    Other: Observation

Interventions

  • OtherObservation

    Observation

06

What researchers measure

Primary outcomes

  1. levels of anti-nephrin in blood by ELISA

    temporal association of anti-nephrin with clinical remission of nephrotic syndrome

    Time frame: up to 12 months

Secondary outcomes

  1. changes in auto-antibodies in blood associated with membranous nephropathy

    temporal association of auto-antibodies with clinical remission of nephrotic syndrome

    Time frame: up to 24 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — Upon reasonable request to the primary investigator.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2024; primary completion for Apr 2034, 120 months later.

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

Registered
Mar 11, 2024
First posted
Mar 18, 2024
StartEst.
Apr 1, 2024
Primary completionEst.
Apr 1, 2034
CompletionEst.
Apr 1, 2034
Last update
Mar 19, 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 Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06315504
Lead sponsor
Iain Bressendorff
Responsible party
Iain Bressendorff (MD PhD, Herlev Hospital) — Sponsor-investigator
First posted
Mar 18, 2024
Start date
Apr 1, 2024 (estimated)
Primary completion
Apr 1, 2034 (estimated)
Completion
Apr 1, 2034 (estimated)
Last update
Mar 19, 2024

Study contacts

Iain Bressendorff, MD PhD
Contact
iain.oshoej.bressendorff@regionh.dk
+4524277139
Ditte Hansen, MD PhD
Contact
ditte.hansen.04@regionh.dk
+4538682056

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 Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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