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Immunologically-Mediated Kidney Diseases Sample Collection and Analysis

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Study Aim

This study aims to collect and analyze blood samples from patients with autoimmune kidney diseases to support ongoing laboratory research.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Urogenital Diseases+11

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 10 to 99 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 1992
See protocol details

Summary

Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ContactMeryl A Waldman, M.D.More contacts
Last updated: July 16, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 25, 1992

Actual date on which the first participant was enrolled.

Study Description: This study evaluates participants with known or suspected immunologically-mediated kidney diseases, including but not limited to nephrotic syndrome, glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated with other systemic or connective tissue disorders. Participants who have immunologically-mediated diseases with potential for kidney disease will be evaluated as well. Studies will include characterization of the clinical and laboratory features of these disorders, studies of natural history and complications, evaluation of responses to standard treatment. Blood and urine samples will be collected for immunological research conducted under this protocol. Objectives: Primary: -To collect samples and data obtained during standard clinical care that can be used to better understand rare forms of immunologically-mediated renal disorders, atypical renal disease that have not been fully characterized, and to allow for future research studies. Exploratory: * Characterize immunologically-mediated kidney diseases with regard to immune dysregulation, immune cell populations and role of complement activation. * Development of assays for novel antibodies. * Search for additional antibodies involved in the pathogenesis of membranous nephropathy and other glomerular diseases. * Assess changes in metabolic (e.g. vitamin D, lipids) and endocrine function (e.g. thyroid, adrenal function) during the evolution of the nephrotic state, during treatment and during remission. * Identify disease-causing memory B cells in participants with membranous nephropathy and correlation with membranous nephropathy relapse. Assess biological effects of phospholipase A2-receptor antibody epitope on the isolated memory B-cells. * Compare immune cell types, including B and T cell populations and cell type specific markers in the pathogenesis of immune-mediated kidney disease. * Compare changes in metabolome and proteome of urine and blood during the nephrotic syndrome, during treatment and in remission. * Computational analysis of renal structures which may provide predictive methods that would discriminate progressors from non-progressors beyond sclerosis in membranous nephropathy.

NCT00001979
Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ContactMeryl A Waldman, M.D.More contacts
Last updated: July 16, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsNephrosisPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesKidney DiseasesNephrotic SyndromeRenal Insufficiency, Chronic

Criteria

3 inclusion criteria required to participate
Ability of the participant or guardian to understand and the willingness of the participant or guardian to provide written informed consent

Adults >= 18 years of age and children 10-17 years of age

Participants with 1. known, proven, or suspected immunologically-mediated kidney diseases, including but not limited to nephrotic syndrome, glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated with other systemic or connective tissue disorders, OR 2. immunologically-mediated diseases with the potential for kidney disease

2 exclusion criteria prevent from participating
Concomitant medical problems which would confound the interpretation of studies of the immunologic kidney disorder

Concomitant medical, surgical, or other conditions for which inadequate facilities or funds are available to support their care at the NIH

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
Recruiting
One Study Center