This study is currently recruiting participants.
Number
000908-DK
Sponsoring Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Autoimmune Disease; Nephrotic Syndrome; Flow Cytometry; Proteinuria; Kidney Disease; Natural History
Recruitment Keyword(s)
None
Condition(s)
Kidney Disease; Nephrotic Syndrome
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Diabetes and Digestive and Kidney Diseases
An exploratory study examining the variety of immune cells, including B and T cell populations implicated in the genesis and progression of membranous nephropathy (MN). Current treatments target either the immune system in a broad fashion or specifically deplete peripheral B cell populations. The study hypothesis is that single cell profiling of peripheral blood and urine immune cells will show changes specific to different disease states (at disease onset, after immunosuppressive treatment, after remission and relapse) and will contribute to a deeper, more comprehensive understanding of disease mechanisms and immune dysregulation contributing to membranous nephropathy.
Objectives:
Primary Objective:
To compare immune cell types, their numbers, and their gene transcription in blood and urine samples from membranous nephropathy subjects before and after treatment with rituximab or other B cell-directed therapies that suppress the immune response. Cell types and numbers will be determined using flow cytometry. Changes in gene transcription and identification of cell types through correlation with cell type-specific marker genes will be accomplished using single-cell RNA sequencing.
Secondary Objectives:
-To determine changes in the metabolism of immune cells with the goal to identify metabolic pathways that are affected in membranous nephropathy.
-To characterize changes in the proteome of blood and urine samples with the aim to identify proteins involved in the pathogenesis of membranous nephropathy.
-To explore the functional evolution of membranous nephropathy-specific antibodies and their roles in membranous nephropathy disease progression and treatment.
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Eligibility Criteria Data and samples from 50 adult subjects enrolled in 92-DK-0156 or 09-DK-0223 who are currently being followed, or will be followed, at the Kidney Diseases Branch will be considered for this exploratory study. The study will include data and samples from subjects who have biopsy-proven membranous nephropathy and manifest antibodies to PLA2R, THSD7A or other known membranous antigens (i.e. NELL1). Subjects whose data and samples are included will have one of three clinical responses defined as a partial remission or complete remission: active MN, in remission and have not received immunosuppressive therapy for at least three months; relapsed but responded to treatment or relapsed and did not respond to treatment; did not respond to any treatment. Data and samples will not be included from subjects who were minors (age <18 years of age) at the time that consent for 92-DK-0156 was signed, or from subjects who choose not to consent to this protocol.
Data and samples from 50 adult subjects enrolled in 92-DK-0156 or 09-DK-0223 who are currently being followed, or will be followed, at the Kidney Diseases Branch will be considered for this exploratory study. The study will include data and samples from subjects who have biopsy-proven membranous nephropathy and manifest antibodies to PLA2R, THSD7A or other known membranous antigens (i.e. NELL1). Subjects whose data and samples are included will have one of three clinical responses defined as a partial remission or complete remission: active MN, in remission and have not received immunosuppressive therapy for at least three months; relapsed but responded to treatment or relapsed and did not respond to treatment; did not respond to any treatment.
Data and samples will not be included from subjects who were minors (age <18 years of age) at the time that consent for 92-DK-0156 was signed, or from subjects who choose not to consent to this protocol.
Principal Investigator
Referral Contact
For more information: