COVID-19 Infection and Idiopathic Membranous Nephropathy | NCT05691179

Studies
COVID-19 Infection and Idiopathic Membranous Nephropathy

NCT05691179

Sponsor

Beijing Friendship Hospital

Status

Unknown status

Last Update Posted

Feb 14, 2023Actual

Enrollment

130Estimated

Phase

Not provided

Conditions

Idiopathic Membranous Nephropathy

Interventions

Not provided

Countries

China

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

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2022Actual

Primary Completion Date

May 31, 2023Estimated

Completion Date

May 31, 2023Estimated

First Submitted Date

Jan 18, 2023

First Submission Date that Met QC Criteria

Jan 18, 2023

First Posted Date

Jan 19, 2023Actual

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

Feb 10, 2023

Last Update Posted Date

Feb 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wenhu Liu, Professor Wenhu Liu, Beijing Friendship HospitalPrincipal Investigator

Lead Sponsor

Beijing Friendship HospitalOTHER

Collaborators

Name	Class
Beijing Pinggu District Hospital	OTHER
Beijing Fangshan District Liangxiang Hospital	OTHER

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

Infection is one of common risk factors for relapsing of idiopathic membranous nephropathy (IMN). However, it is still unclear wheather COVID-19 infection can induce the relapsing of IMN. Herein, in this prospective, multi-center, cohort study, the investigator enrolled the IMN patients with COVID-19 infection.

All subjects will be followed for three months with four visits at 1, 2 and 3 months. Then the investigator will compare the rate of replase of IMN in the two groups to evaluate the association of COVID-19 infection and replapse of IMN.

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

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID-19 infection group		the patients with IMN and COVID-19 infection

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
primary outcome	relaspe of nephrotic syndrome: proteinuria<0.3g/d, serum albumin>30g/l, serum creatitine below 111 μmol/l	3 months

Secondary Outcomes

Measure	Description	Time Frame
secondary outcome	relaspe of nephrotic syndrome: proteinuria<3.5g/d (decreased over 50% of baseline), serum albumin>30g/l, steady serum creatitine (fluctuated less than 20% of baseline), meet the above criteria over 2 times	0.5, 1, and 2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

the status of nephrotic syndrome is complete remmision or partial remmision;
estimated glomerular filtration rate (eGFR according to the CKD-EPI formula) ≥60 mL/min per 1.73 m2;
patients with a moderate risk of IMN.

Exclusion Criteria:

secondary causes of MN;
the labarotary data two months before enrolement is absent.

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

All eligible IMN patients with COVID-19 infection can be enrolled.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zongli Diao, Dr.	Contact	86-10-63138579		diaozl@ccmu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Friedship Hospital	Recruiting	Beijing	Beijing Municipality	100050	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015433	Glomerulonephritis, Membranous

Ancestor Terms

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases

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