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NCT05169411 · ClinicalTrials.gov registry record

Preserving Kidney Function in Children With Chronic Kidney Disease

A clinical trial of Pediatric Kidney Disease and Chronic Kidney Disease Stage 3, sponsored by Children's Hospital of Philadelphia.

Completed
Registry status
20,240
Enrollment target
1
Study location

NCT05169411 is a study of Pediatric Kidney Disease and Chronic Kidney Disease Stage 3 that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 20,240 participants, above the 141-participant average among 4 other Pediatric Kidney Disease trials with a reported enrollment target (14255% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT05169411, a study of Pediatric Kidney Disease and Chronic Kidney Disease Stage 3, has completed, sponsored by Children's Hospital of Philadelphia.

COMPLETED
Registry status
20,240 participants
Enrollment target
1
Study location

Study Summary

Pediatric chronic kidney disease (CKD) results from health conditions that reduce kidney function for \>3 months. It can progress to end-stage kidney disease (ESKD), which requires dialysis or kidney transplant. In adults, CKD is common and caused mainly by hypertension and diabetes. CKD in childhood is rare and caused primarily by congenital anomalies of the genitourinary system and immune-mediated disorders. The best estimate of pediatric CKD prevalence is \<1/15,000 pediatric population. Hypertension occurs in 50% of affected children and is a major risk factor for decline in kidney function. Several clinical practice guidelines have offered recommendations for blood pressure (BP) management in pediatric CKD; however, clinical trial and large-scale observational data are limited, leading to a weak evidence base and substantial practice variation. The purpose of PRESERVE is to provide new knowledge to inform shared decision-making regarding BP management for pediatric CKD. We will leverage the Patient-Centered Outcomes Research network (PCORnet®) infrastructure to conduct large-scale observational studies that will address BP management knowledge gaps for pediatric CKD and sub-groups for whom antihypertensive treatment and outcome associations may be different (e.g., cause of kidney disease and proteinuria). The project's specific aims are: Aim 1-Enhance the PCORnet Common Data Model (CDM) for pediatric and rare kidney disease research. We will expand and improve the PCORnet CDM with new pediatric- and kidney-specific variables, study-specific data quality optimization, and linkage with the chronic kidney disease in children (CKiD) cohort study and the US Renal Data System (USRDS). CKiD directly measures kidney function \[ie, glomerular filtration rate (GFR)\] and includes Ambulatory Blood Pressure Monitoring (ABPM). The USRDS provides complete capture of renal replacement therapy \[(RRT) dialysis and transplant\], two components of the primary clinical outcome.

Interventions

  • DIAGNOSTIC_TEST Blood pressure
  • DIAGNOSTIC_TEST Urine protein

Study Locations (1)

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Trial Details

FieldValue
Enrollment Target 20,240 participants
Start Date 2023-09-22
Est. Completion 2024-07-31

Sponsor

Children's Hospital of Philadelphia

431 total trials

What the Registry Record Tells You About NCT05169411

The ClinicalTrials.gov registry entry for NCT05169411 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 20,240 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 141-participant average among 4 other Pediatric Kidney Disease trials with a reported enrollment target (14255% higher). The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Pediatric Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Blood pressure is the first listed.

NCT05169411 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT05169411 about?

NCT05169411 is a clinical study titled "Preserving Kidney Function in Children With Chronic Kidney Disease". Pediatric chronic kidney disease (CKD) results from health conditions that reduce kidney function for \>3 months. It can progress to end-stage kidney disease (ESKD), which requires dialysis or kidney transplant. In adults, CKD is common and caused mainly by hypertension and diabetes. CKD in childhoo...

What is the current status of trial NCT05169411?

This trial is currently completed. The enrollment target is 20,240 participants. The study started on 2023-09-22. Estimated completion is 2024-07-31.

What conditions does trial NCT05169411 study?

This clinical trial studies the following conditions: Pediatric Kidney Disease, Chronic Kidney Disease Stage 3, Chronic Kidney Disease Stage 2.

What interventions are being tested in trial NCT05169411?

The interventions under investigation include: Blood pressure (DIAGNOSTIC_TEST), Urine protein (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05169411?

This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05169411 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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