Studies of Immunologically-Mediated Kidney Diseases

  • STATUS
    Recruiting
  • participants needed
    2000
  • sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Updated on 20 October 2022
nephropathy
glomerulonephritis
lupus
autoimmune diseases
membranous nephropathy
nephritis

Summary

Kidney diseases related to the immune system include, nephrotic syndrome, glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated with connective tissue disorders.

This study will allow researchers to admit and follow patients suffering from autoimmune diseases of the kidney. It will attempt to provide information about the causes and specific abnormalities associated with autoimmune kidney disease.

Patients with kidney disease as a result of their immune system, and patients with diseases of the immune system who may later develop kidney disease, will be potential subjects for this study.

Patients will undergo a history and physical examination, and standard laboratory test to more closely understand the causes, signs, symptoms, and responses to medication of these diseases. Based on these evaluations the patients may qualify as candidates for other experimental studies. At any time these patients may be asked to submit blood or urine samples for further research.

Description

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
  • To facilitate the program of research on immunologically-mediated kidney diseases:
  • Better understand rare forms of immunologically-mediated renal disorders, those with atypical renal disease, or those whose renal diseases have not been fully characterized. Enrolled participants will serve as a catalyst for development of new therapeutic interventions.
Exploratory

To conduct further research to fully characterize immunologicallymediated kidney diseases:

  • Development of assays for novel antibodies.
  • Search for additional antibodies involved in the pathogenesis of membranous nephropathy.
  • Assess changes in metabolic and endocrine function during nephrotic state 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.
  • Computational analysis of renal structures which may provide predictive method that would discriminate progressors from non-progressors beyond sclerosis in membranous nephropathy.

Details
Condition Kidney Disease, Nephrotic Syndrome
Clinical Study IdentifierNCT00001979
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last Modified on20 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female participants greater than or equal to 18 years of age and children 10-17
years of age
Participants with 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
Participants who have Immunologically-mediated diseases with the potential for kidney
disease
Ability of the participant or guardian to understand and the willingness of the participant
or guardian to provide written informed consent

Exclusion Criteria

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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