Circulating Factors in Nephrotic Syndrome | NCT06315504

Studies
Circulating Factors in Nephrotic Syndrome

NCT06315504

Sponsor

Iain Bressendorff

Status

Not yet recruiting

Last Update Posted

Mar 19, 2024Actual

Enrollment

104Estimated

Phase

Not provided

Conditions

Nephrotic Syndrome
Membranous Nephropathy
Minimal Change Disease
Primary Focal Segmental Glomerulosclerosis

Interventions

Observation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Estimated

Primary Completion Date

Apr 1, 2034Estimated

Completion Date

Apr 1, 2034Estimated

First Submitted Date

Mar 11, 2024

First Submission Date that Met QC Criteria

Mar 11, 2024

First Posted Date

Mar 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2024

Last Update Posted Date

Mar 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

104Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with de novo nephrotic syndrome			Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	Observation	Patients with de novo nephrotic syndrome

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
levels of anti-nephrin in blood by ELISA	temporal association of anti-nephrin with clinical remission of nephrotic syndrome	up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
changes in auto-antibodies in blood associated with membranous nephropathy	temporal association of auto-antibodies with clinical remission of nephrotic syndrome	up to 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 biopsy
Able to give written informed consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

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

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Upon reasonable request to the primary investigator.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009404	Nephrotic Syndrome
D015433	Glomerulonephritis, Membranous
D009402	Nephrosis, Lipoid

Ancestor Terms

ID	Term
D009401	Nephrosis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided