A Real World Study About PMN
ConditionPrimary Membranous Nephropathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWei Chen
About this trial
The investigators designed a randomized, controlled, multicenter clinical study to compare the efficacy and safety of rituximab combined with hormones versus rituximab monotherapy in the treatment of primary membranous nephropathy. At the same time, the investigators conducted a real-world study on patients who did not meet the inclusion and exclusion criteria or were unwilling to enter the RCT cohort, to further observe the trial results in a broader population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
With secondary membranous nephropathy (such as hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes);
Active infection, such as active hepatitis B or hepatitis C, tuberculosis (evidence of active tuberculosis infection within 1 year), or human immunodeficiency virus HIV infection (positive for anti-HIV antibodies), etc.
A history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or organ transplantation.
Trial population
Patients diagnosed as primary membranous nephropathy (PMN) by renal biopsy, with indications for immunosuppressive therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
The complete response rate at 12 months
The complete response rate at 12 months
Time frame
12 monthsSecondary outcomes
1
Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response)
Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response)
Time frame
24 months2
Median remission time
Median remission time
Time frame
24 months3
Proportion of patients without recurrence at 12, 18 and 24 months
Proportion of patients without recurrence at 12, 18 and 24 months
Time frame
24 months4
Median non-recurrence time
Median non-recurrence time
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wei Chen
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Sponsor institution
Source ClinicalTrials.gov