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Immune System Related Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00001979
Recruitment Status : Recruiting
First Posted : January 21, 2000
Last Update Posted : May 26, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Description
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Brief 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.


Condition or disease
Kidney Disease Nephrotic Syndrome

Detailed 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Studies of Immunologically-Mediated Kidney Diseases
Actual Study Start Date : June 25, 1992

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Patients
Patients with known or suspected immunologically-mediated kidney diseases or immunologically-mediated diseases with potential for kidney disease.


Outcome Measures
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Primary Outcome Measures :
  1. Provision of biospecimens [ Time Frame: ongoing ]
    Patients with autoimmune diseases for whom there are no current experimental treatment protocols can be admitted for study and follow-up; they will provide a ready pool of candidates who can be asked to provide blood specimens for ongoing laboratory studies.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients 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, or immunologically-mediated diseases with the potential for kidney disease.@@@
Criteria
  • 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001979


Contacts
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Contact: Meryl A Waldman, M.D. (301) 451-6990 waldmanm@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Meryl A Waldman, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information
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Additional Information:

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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00001979    
Other Study ID Numbers: 920156
92-DK-0156
First Posted: January 21, 2000    Key Record Dates
Last Update Posted: May 26, 2023
Last Verified: February 8, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Kidney Disease
Chronic Kidney Disease
Natural History
Additional relevant MeSH terms:
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Kidney Diseases
Nephrotic Syndrome
Nephrosis
Urologic Diseases
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases