COVID-19 Infection and Idiopathic Membranous Nephropathy

Idiopathic Membranous Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691179
• Other study ID #: 2022-P2-429-01
• Status: Recruiting
• Start date: December 10, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2023
• Source: Beijing Friendship Hospital
• Contact: Zongli Diao, Dr.
• Phone: 86-10-63138579
• Email: diaozl[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases

Locations

Country	Name	City	State
China	Beijing Friedship Hospital	Beijing	Beijing
China	Beijing Liangxiang Hospital	Beijing	Beijing
China	Beijing Pinggu Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Beijing Fangshan District Liangxiang Hospital, Beijing Pinggu District Hospital

Country where clinical trial is conducted

China, 

Outcome

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