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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Factors in Nephrotic Syndrome - A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06315504
- Acronym / sponsor ID
- Nephrotic Syndrome Cohort
- Conditions
- Nephrotic Syndrome, Membranous Nephropathy, Minimal Change Disease, Primary Focal Segmental Glomerulosclerosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Iain BressendorffUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2034 (estimated)
- Study completion
- 1 Apr 2034 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with de novo nephrotic syndrome | – | Other: Observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- De novo nephrotic syndrome admitted to hospital for a clinically indicated kidney biopsy.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Kidney transplant recipient
- Previously undergone a kidney biopsy
- Unable to understand written information in Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationObservation | Other | Patients with de novo nephrotic syndrome |
Primary outcome
levels of anti-nephrin in blood by ELISA
Time frame: up to 12 months
temporal association of anti-nephrin with clinical remission of nephrotic syndrome
1 secondary outcome
changes in auto-antibodies in blood associated with membranous nephropathy
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: Undecided. Upon reasonable request to the primary investigator.
Related trials for Nephrotic Syndrome
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Immune System Related Kidney Disease
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RecruitingPhase 2
Belimumab With Rituximab for Primary Membranous Nephropathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrotic Syndrome and Membranous Nephropathy, run by Iain Bressendorff.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iain Bressendorff, MD PhD (+4524277139, iain.oshoej.bressendorff@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
levels of anti-nephrin in blood by ELISA (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024; AzTrials last refreshed its copy on 26 Oct 2026.