COVID-19 Infection and Idiopathic Membranous Nephropathy

NCT05691179 | Unknown

• 1 other identifier: 2022-P2-429-01
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 3

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.

Conditions

Idiopathic Membranous Nephropathy

Outcome Measures

Primary Outcomes (1)

• primary outcome

  relaspe of nephrotic syndrome: proteinuria\<0.3g/d, serum albumin\>30g/l, serum creatitine below 111 μmol/l

  3 months

Secondary Outcomes (1)

• secondary outcome

  0.5, 1, and 2 months

Study Arms (1)

COVID-19 infection group

the patients with IMN and COVID-19 infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead
• Beijing Pinggu District Hospital: collaborator
• Beijing Fangshan District Liangxiang Hospital: collaborator

Study Sites (3)

Beijing Friedship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Beijing Pinggu Hospital

Beijing, Beijing Municipality, 101299, China

RECRUITING

Beijing Liangxiang Hospital

Beijing, Beijing Municipality, 102401, China

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Zongli Diao, Dr.

CONTACT

86-10-63138579; diaozl@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Wenhu Liu

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 19, 2023
• Study Start: December 10, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)