Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05688865
Other study ID # CRE-2022.642
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source Chinese University of Hong Kong
Contact Winston WS Fung, MBBS
Phone 35053528
Email fws898@ha.org.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To assess the correlation of these urinary biomarkers with the serum sample and evaluated the clinical utility of using urinary sample in the detection and prognostication of MGN. Fifty patients with newly diagnosed biopsy proven MGN would be recruited and followed up for 1 years. Serum and urinary biomarkers would be collected every 4 months and their antibody titres measured with ELISA assay.


Description:

The uses of phospholipase A2 receptor and thrombospondin domain containing 7A antibodies have transformed the management of membranous glomerulonephritis (MGN). However, these are mostly based on serum and the utility of urinary biomarkers are yet to be established. The aim of this study is to assess the correlation of these urinary biomarkers with the serum sample and evaluated the clinical utility of using urinary sample in the detection and prognostication of MGN. Fifty patients with newly diagnosed biopsy proven MGN would be recruited and followed up for 1 years. Serum and urinary biomarkers would be collected every 4 months and their antibody titres measured with ELISA assay. The primary outcome would be the correlation of the urinary biomarkers with the corresponding serum markers. The secondary outcome would be the correlation of the urinary biomarkers with clinical parameters such as the slope of eGFR decline, composite renal events such as time to need for renal replacement therapy or renal death and response to treatments. By establishing the clinical correlation of these urinary biomarkers, the use of such biomarkers would be a more attractive option given its non-invasive nature and conveniences as compared to serum samples.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - newly diagnosed biopsy proven primary membranous glomerulonephritis Exclusion Criteria: - secondary causes of membranous nephropathy, e.g. lupus nephritis, viral hepatitis B and C and malignancy

Study Design


Intervention

Other:
urinary markers
urinary marker testing

Locations

Country Name City State
Hong Kong Department of Medicine & Therapeutics, Prince of Wales Hospital Shatin

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum anti-PLA2R levels 12 months
Primary rate of renal function decline eGFR decline 12 months
Secondary progression to end stage kidney disease 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT04095156 - Autoreactive B Cells in Membranous Nephropathy
Not yet recruiting NCT06341205 - Personalized Rituximab Treatment Based on Artificial Intelligence in Membranous Nephropathy (iRITUX) Phase 3
Active, not recruiting NCT04893096 - MOR202 for Refractory MN Phase 2
Completed NCT00405340 - Rituximab in the Treatment of Idiopathic Membranous Nephropathy Phase 0
Recruiting NCT06065852 - National Registry of Rare Kidney Diseases
Active, not recruiting NCT04652570 - Efficacy and Safety of VB119 in Subjects With Membranous Nephropathy Phase 1/Phase 2
Not yet recruiting NCT06242327 - An Outcome Analysis of Primary Membranous Nephropathy
Recruiting NCT03929887 - KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis
Active, not recruiting NCT03949855 - Belimumab With Rituximab for Primary Membranous Nephropathy Phase 2
Completed NCT00983034 - The Effects of Helicobacter Pylori Eradication on Proteinuria in Patients With Membranous Nephropathy N/A
Completed NCT03025828 - Adrenocorticotropic Hormone in Membranous Nephropathy Phase 4
Recruiting NCT05732402 - An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney Diseases Phase 1/Phase 2
Enrolling by invitation NCT04571658 - NEPTUNE Match Study
Active, not recruiting NCT05894512 - Analysis of T- and B-Cell Subpopulations in Membranous Nephropathy
Not yet recruiting NCT05941845 - Interferon Alfa Therapy Based on Th17 Profile in Membranous Nephropathy Phase 2
Completed NCT00518219 - To Compare the Efficacy and Safety of Tripterygium Wilfordii (TW) Versus Valsartan in the Membranous Nephropathy (MN) Phase 4
Completed NCT02199145 - Role of Anti-mouse PLA2R1 ELISA in Membranous Nephropathy N/A
Not yet recruiting NCT04326218 - Immunopathological Analysis in a French National Cohort of Membranous Nephropathy N/A
Active, not recruiting NCT03453619 - Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies Phase 2
Completed NCT01955187 - Sequential Therapy With Tacrolimus and Rituximab in Primary Membranous Nephropathy Phase 3