ClinicalTrials.gg
RecruitingNCT00001979Updated Nov 9, 2026

Immune System Related Kidney Disease

An observational study in Kidney Disease and Nephrotic Syndrome, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Recruiting at 1 site in United States. Open to participants aged 10 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Primary conditionNephrotic SyndromeRegistry: Kidney DiseasesReclassifiedWhy we changed it
Registry
Kidney Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Nephrotic Syndrome
Why
  1. The study's listed conditions name Nephrotic Syndrome, a narrower term within Kidney Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational

From the registry’s dates

  • Started Jun 1992; still recruiting 34 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
10 Years to 99 Years
Sex
All
01

Study 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.

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.
02

Conditions studied

  • Kidney Disease
  • Nephrotic Syndrome

Browse trials for

Keywords

  • Kidney Disease
  • Chronic Kidney Disease
  • Natural History
03

In context

Nephrotic Syndrome Reclassified

191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 125 across 59 observational studies indexed under Nephrotic Syndrome.

Browse Nephrotic Syndrome studies →

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 538 studies on the registry; 55 are open to participants now.

Of its 80 completed or terminated interventional studies of FDA-regulated products, 51 (64%) have results posted.

Compared within Nephrotic Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Kidney Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
10 Years to 99 Years
Sexes eligible
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.@@@

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

In order to be eligible to participate in this study, a participant must meet all of the following criteria:

  1. Adults >= 18 years of age and children 10-17 years of age
  2. 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.
  3. Ability of the participant or guardian to understand and the willingness of the participant or guardian to provide written .

Exclusion criteria

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Concomitant medical problems which would confound the interpretation of studies of the immunologic kidney disorder.
  2. Concomitant medical, surgical, or other conditions for which inadequate facilities or funds are available to support their care at the NIH.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)

Groups and cohorts

  • Patients

    Patients with known or suspected immunologically-mediated kidney diseases or immunologically-mediated diseases with potential for kidney disease.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: ongoing

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

4 registry updates since Sep 25, 2026

Started Jun 1992 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Jan 20, 2000
First posted
Jan 21, 2000
StartActual
Jun 25, 1992
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: description and verification date
4 updates, last Nov 9, 2026
Show all 4 updates
  1. Nov 9, 2026
    Minor edits only
    + 1 other change: description
  2. Nov 5, 2026
    Minor edits only
    + 1 other change: description
  3. Oct 29, 2026
    Minor edits only
    + 1 other change: verification date
  4. Sep 28, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00001979
Responsible party
Sponsor
First posted
Jan 21, 2000
Start date
Jun 25, 1992
Last update
Nov 9, 2026

Study contacts

Meryl A Waldman, M.D.
Contact
waldmanm@mail.nih.gov
(301) 451-6990
Meryl A Waldman, M.D.
principal investigator · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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