Idiopathic Membranous NephropathyNCT05691179
COVID-19 Infection and Idiopathic Membranous Nephropathy
An observational study of Idiopathic Membranous Nephropathy, run by Beijing Friendship Hospital at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Membranous Nephropathy
- How many people
- 130 participants
- Where
- 3 sitesChina
- Study dates
- 10 Dec 2022to 31 May 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All eligible IMN patients with COVID-19 infection can be enrolled.
Who may be able to join
- 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.
Who cannot join
- secondary causes of MN;
- the labarotary data two months before enrolement is absent.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing Friedship Hospital
Beijing, Beijing Municipality, 100050
Wenhu Liu, Doctor, +86-01-63139144, liuwh0211@126.com
Zongli Diao, Master
- Recruiting
Beijing Pinggu Hospital
Beijing, Beijing Municipality, 101299
Chaomin Wang, Dr., 86-10-89992020, minchaowang888@126.com
- Recruiting
Beijing Liangxiang Hospital
Beijing, Beijing Municipality, 102401
Chunyu Wang, Dr., 86-10-81356100, 467400412@qq.com
About this study
Official title: 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.
- Conditions
- Idiopathic Membranous Nephropathy
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 infection group | the patients with IMN and COVID-19 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome
relaspe of nephrotic syndrome: proteinuria<0.3g/d, serum albumin>30g/l, serum creatitine below 111 μmol/l
Measured: 3 months
Secondary outcomes (1)
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
Measured: 0.5, 1, and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start10 Dec 2022
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Pinggu District Hospital, Beijing Fangshan District Liangxiang Hospital
- Responsible party
- Principal investigator, Wenhu Liu, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691179
- Sponsor's protocol ID
- 2022-P2-429-01
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2023
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of COVID-19 Infection and Relapse of Idiopathic Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT05691179
- Acronym / sponsor ID
- 2022-P2-429-01
- Conditions
- Idiopathic Membranous Nephropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Beijing Pinggu District Hospital, Beijing Fangshan District Liangxiang Hospital
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 infection group | – | –the patients with IMN and COVID-19 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All eligible IMN patients with COVID-19 infection can be enrolled.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- secondary causes of MN;
- the labarotary data two months before enrolement is absent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
primary outcome
Time frame: 3 months
relaspe of nephrotic syndrome: proteinuria<0.3g/d, serum albumin>30g/l, serum creatitine below 111 μmol/l
1 secondary outcome
secondary outcome
Time frame: 0.5, 1, and 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Membranous Nephropathy, run by Beijing Friendship Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zongli Diao, Dr. (86-10-63138579, diaozl@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary outcome (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.