Pediatric Longitudinal Glomerular Disease: a PNRC Multi-Institutional Cohort Study
NCT07931170, Recruiting, Pediatric Nephrology Research Consortium
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Pediatric Longitudinal Glomerular Disease: a PNRC Multi-Institutional Cohort Study | ClinicalTrials.gov |
| NCT number | NCT07931170 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 1,000 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Pediatric Nephrology Research Consortium | ClinicalTrials.gov |
| Conditions | 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) | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proteinuria, and change over time thereof (urine protein-creatinine ratio) | Baseline and follow up timepoints (every 6 months) post-diagnosis to be reviewed at end of years 1 and 2 of data collection | 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. | ClinicalTrials.gov |
| Secondary | Percent change in estimated glomerular filtration rate (eGFR) from baseline to follow up | Two years after study initiation | 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. | ClinicalTrials.gov |
| Secondary | eGFR, and change (from baseline) overtime | Two years after study initiation | Measures how much a patient's kidney filtering capacity has increased or decreased over time compared to their initial starting measurement | ClinicalTrials.gov |
| Secondary | Growth trajectory, derived from height and weight | Two years after study initiation | 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. | ClinicalTrials.gov |
| Secondary | Developmental trajectory derived from QOL survey of caregiver | Two years after study initiation | 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. | ClinicalTrials.gov |
| Secondary | Educational attainment trajectory and milestones, derived from QOL of caregiver | Two years after study initiation | 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. | ClinicalTrials.gov |
| Secondary | Caregiver effect: Missed days of school and work for caregiver | Two years after study initiation | 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) | ClinicalTrials.gov |
| Secondary | Unplanned Hospitalization(s) | Two years after study initiation | 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 | ClinicalTrials.gov |
| Secondary | Infections (Urine, ear, skin/tissue, URI and others) | Two years after study initiation | 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 | ClinicalTrials.gov |
| Secondary | Histopathological Response based on serial biopsy reports and images | Two years after study initiation | 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 | ClinicalTrials.gov |
| Secondary | Renal failure (including dialysis-dependence) | Two years after study initiation | 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. | ClinicalTrials.gov |
| Secondary | Renal Transplantation | Two years after study initiation | 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. | ClinicalTrials.gov |
| Secondary | Death | Two years after study initiation | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 6
The papers the trial lists on ClinicalTrials.gov.
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.