Nephrotic SyndromeNCT06315504
Circulating Factors in Nephrotic Syndrome
An observational study of Nephrotic Syndrome and Membranous Nephropathy, run by Iain Bressendorff.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrotic Syndrome, Membranous Nephropathy, Minimal Change Disease
- What is being tested?
- Observation
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Apr 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
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 18 years and older
- All sexes
- Adult, Older adult
Study population: De novo nephrotic syndrome admitted to hospital for a clinically indicated kidney biopsy.
Who may be able to join
- 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 biopsy
- Able to give written informed consent
Who cannot join
- Kidney transplant recipient
- Previously undergone a kidney biopsy
- Unable to understand written information in Danish
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Circulating Factors in Nephrotic Syndrome - A Prospective Observational Cohort Study
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.
- Conditions
- Nephrotic Syndrome, Membranous Nephropathy, Minimal Change Disease, Primary Focal Segmental Glomerulosclerosis
- Being tested
- Observation
- Medical subject headings
- Nephrotic Syndrome, Glomerulonephritis, Membranous, Nephrosis, Lipoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation
| Study group | Role | What they receive |
|---|---|---|
| Patients with de novo nephrotic syndrome | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of anti-nephrin in blood by ELISA
temporal association of anti-nephrin with clinical remission of nephrotic syndrome
Measured: 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
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2034 (estimated)
- Study completion1 Apr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Iain Bressendorff
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Iain Bressendorff, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315504
- Sponsor's protocol ID
- Nephrotic Syndrome Cohort
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request to the primary investigator.