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RecruitingNCT07931170PLUGGED INUpdated Nov 12, 2026

Pediatric Longitudinal Glomerular Disease: a PNRC Multi-Institutional Cohort Study

An observational study in IgA Nephropathy (IgAN), IgA Vasculitis and Idiopathic Immune Complex Glomerulonephritis, sponsored by Pediatric Nephrology Research Consortium. Recruiting at 2 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Pediatric Nephrology Research Consortium · Observational

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Nov 12, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,000
Ages
Up to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 73 studies in Glomerulonephritis, IGA with a site in United States — 25 open to participants now, 37 under way, 16 of them phase 3. Glomerulonephritis, IGA · United States.

Started
2026
with 10 others
Observational
6 of 73
3 open now
Primary completion
2031-12
later than 36 of 36 live
Registered
72nd of 73
by date

Among the 73 studies in Glomerulonephritis, IGA with a site in United States, this one is one of 11 that started in 2026, is one of 6 observational ones, reaches primary completion later than 36 of the 36 other live ones, and was the 72nd registered.

Glomerulonephritis, IGA

276 studies on the registry are indexed under Glomerulonephritis, IGA; 108 are open to participants now.

Browse Glomerulonephritis, IGA studies →

Open to participants now

25 of the 73 studies in Glomerulonephritis, IGA with a site in United States are open now. Recruiting first, the newest first:

19 more — sign in →

All 25 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 68 Glomerulonephritis, IGA studies recruiting now, 39 (57%) set no upper age limit and 24 (35%) stop at 75 or younger; 21 take children under 18; 5 take healthy volunteers.

This study: Up to 18 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 73 studies in Glomerulonephritis, IGA with a site in United States, or all of them as a file.
02

Study summary

To review and collect information from a patients medical record in order to study and research how to help other children with glomerular diseases.

Read the detailed description

This study is designed to look at the natural history of glomerular diseases in children and adolescents in order to direct the research to find cures. This study will also possibly help identify or locate participants that may be eligible for clinical trials.

Mixed retrospective-prospective cohort study (longitudinal, observational, non-interventional study) to research the natural history of glomerular disease in children and adolescents in the US.

Objective: Evaluate the natural history of glomerular disease in children in the United States.

Aim 1: To investigate and determine important relationships among patient/disease characteristics, natural history, treatments, histopathology, and outcomes among pediatric patients with glomerular disease, both across and within pre-specified disease cohorts (see below), by means of multicenter collection, storage, and analysis of longitudinal data.

Aim 2: To provide a platform for and facilitate, with participant consent, rapid assessment of potential participant eligibility for planned and/or ongoing investigator-initiated and/or industry-sponsored clinical trials of pediatric glomerular disease.

20 initial sites were selected to recruit participants with glomerular disease. Patients diagnosed starting in July 2023, as well as newly diagnosed patients can be enrolled. Participants will be followed until 21 years of age.

Data Collection at 6 month timepoints +/- 30 days. Collection starts with demographic information, medical history, and family medical history. Also collected at enrollment and at each time point are standard of care labs, hospitalizations, renal biopsy images, pathology reports and specialized or genetic testing. Participants will be asked to answer quality of life and social determinate of health questionnaires at enrollment and annually. These are optional and will not affect eligibility.

Enrollment expected to be 500 participants per year.

03

Conditions studied

  • IgA Nephropathy (IgAN)
  • IgA Vasculitis
  • Idiopathic Immune Complex Glomerulonephritis
  • C3 Glomerulopathy
  • Membranous Nephropathy
  • Focal and Segmental Glomerulosclerosis
  • Minimal Change Disease
  • Anti-Neutrophilic Cytoplasmic Antibody-GN (ANCA)
  • Lupus Nephritis (LN)
  • Alport Syndrome
  • Infection-related or Post-infectious Glomerulonephritis
  • Idiopathic Nephrotic Syndrome (INS)

Keywords

  • Glomerular
  • Glomerular Disease
  • Nephritis
  • Nephropathy
  • Minimal Change
  • Alport
  • ANCA
  • Lupus
  • Membranous
  • C3G
  • Glomerulopathy
  • IgA
04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will be less than 18 years of age at time of diagnosis and consent, categorized into the following prespecified disease cohorts:

  1. IgA Nephropathy
  2. IgA Vasculitis
  3. Idiopathic Immune Complex Glomerulonephritis (ex: IC-MPGN, Full house GN without diagnosis of Lupus, etc.)
  4. C3 Glomerulopathy
  5. Membranous Nephropathy
  6. Focal and Segmental Glomerulosclerosis
  7. Minimal Change Disease
  8. Anti-Neutrophilic Cytoplasmic antibody-GN (ANCA)
  9. Lupus Nephritis
  10. Alport Syndrome
  11. Infection-related or post-infectious Glomerulonephritis (with or without biopsy)
  12. Idiopathic Nephrotic Syndrome (with or without biopsy)

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

Children with -proven glomerular disease or populations with a clinical diagnosis of glomerular disease

Exclusion criteria

Exclusion Criteria:

Patients who declined (or unable to provide , + informed assent of minors) to participate Patients with End Stage Kidney Disease (Stage 5 CKD, \< 15mL/min/1.73m2)

Terms in these criteria, in plain language(3)

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.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

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.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • IgA Nephropathy (with biopsy)

    Subjects diagnosed with IgA Nephropathy less than 18 years of age

  • IgA Vasculitis (with biopsy)

    Subjects diagnosed with IgA Vasculitis less than 18 years of age

  • Idiopathic Immune Complex Glomerulonephritis (with biopsy)

    Subjects diagnosed with Idiopathic Immune Complex Glomerulonephritis less than 18 years of age

  • C3 Glomerulopathy (with biopsy)

    Subjects diagnosed with C3 Glomerulopathy less than 18 years of age

  • Membranous Nephropathy (with biopsy)

    Subjects diagnosed with Membranous Nephropathy less than 18 years of age

  • Focal and Segmental Glomerulosclerosis (with biopsy)

    Subjects diagnosed with Focal and Segmental Glomerulosclerosis less than 18 years of age

  • Minimal Change Disease (with biopsy)

    Subjects diagnosed with Minimal Change Disease less than 18 years of age

  • Anti-Neutrophilic Cytoplasmic antibody-GN (ANCA) (with biopsy)

    Subjects diagnosed with Anti-Neutrophilic Cytoplasmic antibody-GN (ANCA) less than 18 years of age

  • Lupus Nephritis (with biopsy)

    Subjects diagnosed with Lupus Nephritis less than 18 years of age

  • Alport Syndrome (with biopsy)

    Subjects diagnosed with Alport Syndrome less than 18 years of age

  • Infection-related or post-infectious Glomerulonephritis (with or without biopsy)

    Subjects diagnosed with Infection-related or post-infectious Glomerulonephritis (with or without biopsy) less than 18 years of age

  • Idiopathic Nephrotic Syndrome (with or without biopsy)

    Subjects diagnosed with Idiopathic Nephrotic Syndrome (with or without biopsy) less than 18 years of age

06

What researchers measure

Primary outcomes

  1. Proteinuria, and change over time thereof (urine protein-creatinine ratio)

    To characterize the longitudinal trajectory and progression of proteinuria, measured by urine protein-creatinine ratio (UPCR), following diagnosis and to identify baseline demographic and clinical factors associated with changes in proteinuria over time.

    Time frame: Baseline and follow up timepoints (every 6 months) post-diagnosis to be reviewed at end of years 1 and 2 of data collection

Secondary outcomes

  1. Percent change in estimated glomerular filtration rate (eGFR) from baseline to follow up

    To characterize longitudinal changes in kidney function as measured by estimated glomerular filtration rate (eGFR) and to identify baseline demographic and clinical factors associated with changes in kidney function over time.

    Time frame: Two years after study initiation

  2. eGFR, and change (from baseline) overtime

    Measures how much a patient's kidney filtering capacity has increased or decreased over time compared to their initial starting measurement

    Time frame: Two years after study initiation

  3. Growth trajectory, derived from height and weight

    Describe longitudinal growth patterns (e.g., height, weight, BMI z -scores) and identify disease-related factors associated with impaired growth trajectories. Growth trajectory will be defined as change in height and weight over time. We will calculate height-for-weight Z score, weight-for-height Z score and BMI Z-score over time.

    Time frame: Two years after study initiation

  4. Developmental trajectory derived from QOL survey of caregiver

    Characterizing developmental progression, measured over time and identify clinical factors associated with delays or deviations from expected developmental milestones. Time to attainment of key developmental milestones (derived from QOL survey of caregiver) will be summarized using mean and standard deviation or median and interquartile range. The proportion of patients with delayed development at baseline (first assessment after diagnosis) and follow up will also be reported.

    Time frame: Two years after study initiation

  5. Educational attainment trajectory and milestones, derived from QOL of caregiver

    Evaluation of educational outcomes over follow-up and examine associations between disease severity and academic achievement. Time to attainment of key educational milestones will be summarized using mean and standard deviation or median and interquartile range. The proportion of patients with delayed educational attainment at baseline (first assessment after diagnosis) and follow up will also be reported.

    Time frame: Two years after study initiation

  6. Caregiver effect: Missed days of school and work for caregiver

    To quantify school absenteeism and examine its relationship with disease burden and clinical progression. Missed school days will be summarized using descriptive statistics (mean and standard deviation or median and interquartile range as appropriate)

    Time frame: Two years after study initiation

  7. Unplanned Hospitalization(s)

    To estimate the frequency and timing of unplanned hospitalizations and identify factors associated with unplanned hospitalizations. Unplanned Hospitalization will be summarized using descriptive statistics. The association between clinical factors and number of unplanned hospitalizations will be examined with a multivariable negative binomial regression model

    Time frame: Two years after study initiation

  8. Infections (Urine, ear, skin/tissue, URI and others)

    To characterize the incidence and types of infections during follow -up and evaluate clinical factors associated with increased infection risk. The incidence and type of infection will be reported with the corresponding 95% CI at each follow up time point. The association between clinical factors and infection will be evaluated using multivariable mixed models with random effects for patient and site

    Time frame: Two years after study initiation

  9. Histopathological Response based on serial biopsy reports and images

    To describe longitudinal changes in histopathological findings and evaluate associations between pathological features and disease progression. Histopathological Response will each be summarized in the analytic population during the exposure period using descriptive statistics. Distributions will be compared across age groups where appropriate, using Chi -Square or Fisher's exact test, for categorical variables, and Kruskal-Wallis for continuous variables

    Time frame: Two years after study initiation

  10. Renal failure (including dialysis-dependence)

    To determine the incidence and timing of progression to renal failure (including dialysis-dependence) and to identify prognostic factors associated with risk of progression. The incidence of renal failure will be summarized with the corresponding 95% confidence interval for each disease group. The association between clinical characteristics and time to renal failure will be evaluated using Fine and Gray subdistribution hazard model with prespecified covariates (see above); accounting for mortality (not related to renal failure) and renal transplantation as competing risks.

    Time frame: Two years after study initiation

  11. Renal Transplantation

    To characterize the incidence and timing of renal transplantation and describe clinical characteristics associated with progression to transplant. The incidence of renal transplantation will be summarized with the corresponding 95% confidence interval for each disease group. Association between clinical characteristics and time to renal transplantation will be evaluated with Fine and Gray sub distribution hazard model with prespecified covariates; accounting for mortality (not related to renal transplantation) and renal failure as competing risks. Time to renal transplantation will be defined as time from diagnosis of GD to the first occurrence of renal transplantation and survivors who do not receive renal transplantation will be censored at the last day of follow up or end of study, whichever occurs first.

    Time frame: Two years after study initiation

  12. Death

    To estimate overall survival and identify baseline demographic and clinical factors associated with risk of death during follow-up. Association between clinical characteristics and mortality will be evaluated using a multivariable Cox proportional hazards regression with prespecified baseline and time-varying covariates (see below). Survival time will be defined as time from diagnosis of GD to death and survivors will be censored at the last day of follow up or end of study, whichever occurs first.

    Time frame: Two years after study initiation

07

Study locations

2 of 2 sites recruiting
08

References and documents

Publications

  • United States Renal Data System. Chronic Kidney Disease: Chapter 5. Kidney disease among children and adolescents. 2024 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2024.
  • Szklo M and Nieto EJ. Epidemiology: Beyond the Basics (Jones and Bartlett, Sudbury, MA, USA), 2004, pp. 27-29.
  • International Council for Harmonisation (ICH) E11 (R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population. (18 August 2017) section 2.5
  • Seo-Mayer P, Ashoor I, Hayde N, Laster M, Sanderson K, Soranno D, Wigfall D, Brown D. Seeking justice, equity, diversity and inclusion in pediatric nephrology. Front Pediatr. 2022 Dec 12;10:1084848. doi: 10.3389/fped.2022.1084848. eCollection 2022. PubMed 36578658 ↗
  • Harambat J, van Stralen KJ, Kim JJ, Tizard EJ. Epidemiology of chronic kidney disease in children. Pediatr Nephrol. 2012 Mar;27(3):363-73. doi: 10.1007/s00467-011-1939-1. Epub 2011 Jun 29. PubMed 21713524 ↗
  • Bernard TJ, Armstrong-Wells J, Goldenberg NA. The institution-based prospective inception cohort study: design, implementation, and quality assurance in pediatric thrombosis and stroke research. Semin Thromb Hemost. 2013 Feb;39(1):10-4. doi: 10.1055/s-0032-1329551. Epub 2012 Dec 26. PubMed 23269572 ↗
  • Armstrong-Wells J, Goldenberg NA. Institution-based prospective inception cohort studies in neonatal rare disease research. Semin Fetal Neonatal Med. 2011 Dec;16(6):355-8. doi: 10.1016/j.siny.2011.07.004. Epub 2011 Aug 5. PubMed 21820983 ↗
  • Pitcher D, Braddon F, Hendry B, Mercer A, Barratt J, Steenkamp R, Wong K, Turner AN, Gong W, Gale DP, Saleem MA. Long-Term Outcomes in Nephrotic Syndrome by Kidney Biopsy Diagnosis and Proteinuria. J Am Soc Nephrol. 2025 Apr 17;36(7):1398-1413. doi: 10.1681/ASN.0000000610. PubMed 40244693 ↗
  • Pitcher D, Braddon F, Hendry B, Mercer A, Osmaston K, Saleem MA, Steenkamp R, Wong K, Turner AN, Wang K, Gale DP, Barratt J. Long-Term Outcomes in IgA Nephropathy. Clin J Am Soc Nephrol. 2023 Jun 1;18(6):727-738. doi: 10.2215/CJN.0000000000000135. Epub 2023 Apr 13. PubMed 37055195 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2026 (actual). Primary completion is estimated for Dec 2031, 62 months after the start.

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

Registered
Oct 21, 2026
First posted
Nov 12, 2026
StartActual
Oct 1, 2026
Primary completionEst.
Dec 2031
CompletionEst.
Jun 2032
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
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.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

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
NCT07931170
Lead sponsor
Pediatric Nephrology Research Consortium
Collaborators
Johns Hopkins All Children's Hospital, Washington University School of Medicine, Novartis
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Oct 1, 2026
Primary completion
Dec 2031 (estimated)
Completion
Jun 2032 (estimated)
Last update
Nov 12, 2026

Study contacts

Amy Dutcher, MCR
Contact
adutcher@PNRConsortium.org
6145547621
Teri Crumb, MSN, RN, CCRC
Contact
teri@pnrconsortium.org
616-607-4430
Carla Nester, MD
principal investigator · University of Iowa
William Smoyer, MD
principal investigator · Nationwide Children's Hospital
Joseph Gaut, MD, PhD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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