NCT06315504

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
96mo left

Started Apr 2024

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Apr 2024Apr 2034

First Submitted

Initial submission to the registry

March 11, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2034

Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

10 years

First QC Date

March 11, 2024

Last Update Submit

March 16, 2024

Conditions

Nephrotic SyndromeMembranous NephropathyMinimal Change DiseasePrimary Focal Segmental Glomerulosclerosis

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • changes in auto-antibodies in blood associated with membranous nephropathy

    up to 24 months

Study Arms (1)

Patients with de novo nephrotic syndrome

Other: Observation

Interventions

ObservationOTHER

Observation

Patients with de novo nephrotic syndrome

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and kidney tissue

MeSH Terms

Conditions

Nephrotic SyndromeGlomerulonephritis, MembranousNephrosis, Lipoid

Interventions

Observation

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGlomerulonephritisNephritisAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Iain Bressendorff, MD PhD

CONTACT

+4524277139iain.oshoej.bressendorff@regionh.dk

Ditte Hansen, MD PhD

CONTACT

+4538682056ditte.hansen.04@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 11, 2024

First Posted

March 18, 2024

Study Start

April 1, 2024

Primary Completion (Estimated)

April 1, 2034

Study Completion (Estimated)

April 1, 2034

Last Updated

March 19, 2024

Record last verified: 2024-03