Kidney DiseaseNCT00001979
Immune System Related Kidney Disease
An observational study of Kidney Disease and Nephrotic Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 99 years
- Conditions the study is for
- Kidney Disease, Nephrotic Syndrome
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 1992to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.@@@
Who may be able to join
- In order to be eligible to participate in this study, a participant must meet all of the following criteria:
- Adults >= 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, OR
- 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.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Studies of Immunologically-Mediated Kidney Diseases
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.
Read more
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....
Read the 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:
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.
- Conditions
- Kidney Disease, Nephrotic Syndrome
- Keywords
- Kidney Disease, Chronic Kidney Disease, Natural History
- Medical subject headings
- Kidney Diseases, Nephrotic Syndrome, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with known or suspected immunologically-mediated kidney diseases or immunologically-mediated diseases with potential for kidney disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provision of biospecimens
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.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2000 (estimated)
- Study start25 Jun 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Meryl A Waldman, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001979
- Sponsor's protocol ID
- 920156
- Other IDs
- 92-DK-0156
- Status last verified
- 27 Oct 2026
- First submitted
- 20 Jan 2000
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Immunologically-Mediated Kidney Diseases
- ClinicalTrials.gov ID
- NCT00001979
- Acronym / sponsor ID
- 920156
- Conditions
- Kidney Disease, Nephrotic Syndrome
- Keywords
- Kidney Disease, Chronic Kidney Disease, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 25 Jun 1992 (actual)
- First posted
- 21 Jan 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients with known or suspected immunologically-mediated kidney diseases or immunologically-mediated diseases with potential for kidney disease. |
Who may qualify
- Ages
- 10 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.@@@
Key inclusion criteria (6 listed)
- In order to be eligible to participate in this study, a participant must meet all of the following criteria:
- Adults >= 18 years of age and children 10-17 years of age
- Participants with
- Ability of the participant or guardian to understand and the willingness of the participant or guardian to provide written informed consent.
Key exclusion criteria (3 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meryl A Waldman, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease and Nephrotic Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meryl A Waldman, M.D. ((301) 451-6990, waldmanm@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provision of biospecimens (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.