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Immune System Related Kidney Disease

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ClinicalTrials.gov Identifier: NCT00001979
Recruitment Status : Recruiting
First Posted : January 21, 2000
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Tracking Information
First Submitted Date January 20, 2000
First Posted Date January 21, 2000
Last Update Posted Date October 8, 2020
Actual Study Start Date June 25, 1992
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: July 25, 2019)
Provision of biospecimens [ Time Frame: On-going ]
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Immune System Related Kidney Disease
Official Title Studies of Immunologically-Mediated Kidney Diseases
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.

Detailed Description 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, will be evaluated at the Clinical Center. Patients 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, and determination of the patients' eligibility to enter other experimental diagnostic or therapeutic protocols. Patients may be asked to contribute blood and/or urine samples for immunological research studies.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.@@@
Condition
  • Kidney Disease
  • Nephrotic Syndrome
Intervention Not Provided
Study Groups/Cohorts Patients
Patients with known or suspected immunologically-mediated kidney diseases or immunologically-mediated diseases with potential for kidney disease.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 29, 2020)
999999
Original Enrollment
 (submitted: June 23, 2005)
9999
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION CRITERIA:

Immunologically-mediated renal diseases, proven or suspected.

Immunologically-mediated diseases with potential for kidney disease.

Willingness of the patient or guardian to give 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Meryl A Waldman, M.D. (301) 451-6990 waldmanm@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00001979
Other Study ID Numbers 920156
92-DK-0156
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
Study Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators Not Provided
Investigators
Principal Investigator: Meryl A Waldman, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date July 17, 2020