COVID-19 Infection and Idiopathic Membranous Nephropathy

The Association of COVID-19 Infection and Relapse of Idiopathic Membranous Nephropathy

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Membranous Nephropathy

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friedship Hospital
    • Beijing, Beijing, China, 101299
      • Recruiting
      • Beijing Pinggu Hospital
    • Beijing, Beijing, China, 102401
      • Recruiting
      • Beijing Liangxiang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
COVID-19 infection group; the patients with IMN and COVID-19 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Beijing Pinggu District Hospital; Beijing Fangshan District Liangxiang Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2022
• Primary Completion (ANTICIPATED): May 31, 2023
• Study Completion (ANTICIPATED): May 31, 2023

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (ACTUAL): January 19, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Kidney Diseases; Glomerulonephritis, Membranous
• Other Study ID Numbers: 2022-P2-429-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No