Chronic Kidney Disease Stage 2PRESERVENCT05169411
Preserving Kidney Function in Children With Chronic Kidney Disease
An observational study of Chronic Kidney Disease Stage 2 and Chronic Kidney Disease Stage 3, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Chronic Kidney Disease Stage 2, Chronic Kidney Disease Stage 3, Pediatric Kidney Disease
- What is being tested?
- Blood pressure and Urine protein
- How many people
- 20,240 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children ages 1 to <18 years with chronic kidney disease stages 2-3 at cohort entrance.
Who may be able to join
- Include: patient has an outpatient, ED, or inpatient visit with a physician
- Include: 1 or more eGFR values 30-89 mL/min/1.73m2 using the CKiD U25 formula
- Include: 2 or more eGFR values 30-89 mL/min/1.73m2 on different days using the CKiD U25 formula
- Include: 2 eGFR values in the range 30-89 mL/min/1.73m2 using the CKiD U25 formula greater than or equal to 90 days apart.
Who cannot join
- Exclude: eGFR value >=90 ml/min using the CKiD U25 formula between the two qualifying eGFRs in mild-moderate range
- Exclude if: Age <1 and >=18 years on CED (see below for definition of CED)
- Exclude if: no nephrologist visit at any time during the study period
- Exclude: if chronic dialysis on or before CED
- Exclude: if kidney transplant on or before CED
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19103
About this study
Official title: Preserving Kidney Function in Children With Chronic Kidney Disease (PRESERVE)
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:
Read more
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.
Aim 2-Describe and examine the effectiveness of consistent BP and urine protein monitoring for preserving kidney function. We will describe the consistency of BP and urine protein monitoring and will contrast clinic BP assessments with ABPM. In longitudinal analyses, we will evaluate the effects of consistent monitoring of BP and urine protein on kidney function decline.
Aim 3-Compare the effectiveness of BP medication strategies for preserving kidney function. We will compare the effects of (1) BP levels when treatment was started, (2) choice of first-line therapies, and (3) ongoing BP control on kidney function decline. We will also assess adverse events related to hypertension management.
Aim 4-Assess patients' lived experiences related to BP management. We will field a survey that examines patient-centered outcomes by level of BP control and medication management approaches. This Aim will provide information on experiences with BP management from the perspectives of patients, parents, and clinicians that will complement the clinical outcomes studied in Aims 2 and 3.
- Being tested
- Blood pressure, Urine protein
- Keywords
- chronic, child, pediatric, hypertension, proteinuria
- Medical subject headings
- Renal Insufficiency, Chronic, Bronchiolitis Obliterans Syndrome, Hypertension, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressureDiagnostic test
The first anti-hypertensive prescribed will be categorized as ACEi, ARB, thiazide diuretic, loop diuretic, beta-blocker, calcium channel blocker, other, and none; secondary analyses will combine ACEi and ARB into a single RAAS blocker category. We will conduct additional secondary analyses for specific medications with sufficient sample sizes.
Urine proteinDiagnostic test
Evaluating urine protein for children with CKD and hypertension is another guideline recommendation, but the frequency, type of assessment (qualitative or quantitative urine protein), and utility for patients without hypertension are unclear. We will determine whether urine protein is evaluated at each encounter and create a dichotomous indicator.
| Study group | Role | What they receive |
|---|---|---|
| angiotensin converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) categories | The first anti-hypertensive prescribed will be categorized as ACEi, ARB, thiazide diuretic, loop diuretic, beta-blocker, calcium channel blocker, other, and none. Receives: Diagnostic Test: Blood pressure | |
| Combined renin-angiotensin-aldosterone system (RAAS) blocker category | Secondary analyses will combine ACEi and ARB into a single RAAS blocker category. Receives: Diagnostic Test: Blood pressure | |
| Urine protein dichotomous indicator | We will determine whether urine protein is evaluated at each encounter and create a dichotomous indicator. Receives: Diagnostic Test: Urine protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decline in estimated glomerular filtration rate (eGFR)
Time from cohort entrance (defined as day when first estimated glomerular filtration rate will be measured by the following criteria: (1) >50% decline in eGFR, as measured by the U25 formula; (2) eGFR <=15 ml/min as measured by the U25 formula); (3) initiation of chronic dialysis; or (4) kidney transplant.
U25 formula: https://doi.org/10.1016/j.kint.2020.10.047
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start22 Sep 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 2Studies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Retrospective
- Enrolment
- 20,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Children's Hospital Medical Center, Cincinnati, Ann & Robert H Lurie Children's Hospital of Chicago, Nationwide Children's Hospital, Seattle Children's Hospital, Stanford University, University of Colorado, Denver, Duke University, University of North Carolina, Chapel Hill, Indiana University, Medical College of Wisconsin, University of Iowa, Johns Hopkins University, University of Michigan, University of Florida, University of Miami, University of Pennsylvania, Alfred I. duPont Hospital for Children
- Responsible party
- Sponsor
- Investigators
- Chris Forrest, MD, Principal investigator, Children's Hospital of PhiladelphiaMichelle Denburg, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169411
- Sponsor's protocol ID
- 21-018814
- Other IDs
- RD-2020C22-0338
- Acronym
- PRESERVE
- Status last verified
- Aug 2024
- First submitted
- 11 Nov 2021
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are from electronic health records, so individual level patient data cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preserving Kidney Function in Children With Chronic Kidney Disease (PRESERVE)
- ClinicalTrials.gov ID
- NCT05169411
- Acronym / sponsor ID
- PRESERVE / 21-018814
- Keywords
- chronic, child, pediatric, hypertension, proteinuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,240 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Children's Hospital Medical Center, Cincinnati, Ann & Robert H Lurie Children's Hospital of Chicago, Nationwide Children's Hospital, Seattle Children's Hospital, Stanford University, University of Colorado, Denver, Duke University, University of North Carolina, Chapel Hill, Indiana University, Medical College of Wisconsin, University of Iowa, Johns Hopkins University, University of Michigan, University of Florida, University of Miami, University of Pennsylvania, Alfred I. duPont Hospital for Children
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 27 Dec 2021 (actual)
- 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.
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.
Aim 2-Describe and examine the effectiveness of consistent BP and urine protein monitoring for preserving kidney function. We will describe the consistency of BP and urine protein monitoring and will contrast clinic BP assessments with ABPM. In longitudinal analyses, we will evaluate the effects of consistent monitoring of BP and urine protein on kidney function decline.
Aim 3-Compare the effectiveness of BP medication strategies for preserving kidney function. We will compare the effects of (1) BP levels when treatment was started, (2) choice of first-line therapies, and (3) ongoing BP control on kidney function decline. We will also assess adverse events related to hypertension management.
Aim 4-Assess patients' lived experiences related to BP management. We will field a survey that examines patient-centered outcomes by level of BP control and medication management approaches. This Aim will provide information on experiences with BP management from the perspectives of patients, parents, and clinicians that will complement the clinical outcomes studied in Aims 2 and 3.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| angiotensin converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) categories | – | Diagnostic Test: Blood pressureThe first anti-hypertensive prescribed will be categorized as ACEi, ARB, thiazide diuretic, loop diuretic, beta-blocker, calcium channel blocker, other, and none. |
| Combined renin-angiotensin-aldosterone system (RAAS) blocker category | – | Diagnostic Test: Blood pressureSecondary analyses will combine ACEi and ARB into a single RAAS blocker category. |
| Urine protein dichotomous indicator | – | Diagnostic Test: Urine proteinWe will determine whether urine protein is evaluated at each encounter and create a dichotomous indicator. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children ages 1 to <18 years with chronic kidney disease stages 2-3 at cohort entrance.
Key inclusion criteria (4 listed)
- Include: patient has an outpatient, ED, or inpatient visit with a physician
- Include: 1 or more eGFR values 30-89 mL/min/1.73m2 using the CKiD U25 formula
- Include: 2 or more eGFR values 30-89 mL/min/1.73m2 on different days using the CKiD U25 formula
- Include: 2 eGFR values in the range 30-89 mL/min/1.73m2 using the CKiD U25 formula greater than or equal to 90 days apart.
Key exclusion criteria (5 listed)
- Exclude: eGFR value >=90 ml/min using the CKiD U25 formula between the two qualifying eGFRs in mild-moderate range
- Exclude if: Age <1 and >=18 years on CED (see below for definition of CED)
- Exclude if: no nephrologist visit at any time during the study period
- Exclude: if chronic dialysis on or before CED
- Exclude: if kidney transplant on or before CED
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressureThe first anti-hypertensive prescribed will be categorized as ACEi, ARB, thiazide diuretic, loop diuretic, beta-blocker, calcium channel blocker, other, and none; secondary analyses will combine ACEi and ARB into a single RAAS blocker category. We will conduct additional secondary analyses for specific medications with sufficient sample sizes. | Diagnostic test | Combined renin-angiotensin-aldosterone system (RAAS) blocker category, angiotensin converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) categories |
| Urine proteinEvaluating urine protein for children with CKD and hypertension is another guideline recommendation, but the frequency, type of assessment (qualitative or quantitative urine protein), and utility for patients without hypertension are unclear. We will determine whether urine protein is evaluated at each encounter and create a dichotomous indicator. | Diagnostic test | Urine protein dichotomous indicator |
Primary outcome
Decline in estimated glomerular filtration rate (eGFR)
Time frame: up to 18 months
Time from cohort entrance (defined as day when first estimated glomerular filtration rate will be measured by the following criteria: (1) >50% decline in eGFR, as measured by the U25 formula; (2) eGFR <=15 ml/min as measured by the U25 formula); (3) initiation of chronic dialysis; or (4) kidney transplant. U25 formula: https://doi.org/10.1016/j.kint.2020.10.047
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No. Data are from electronic health records, so individual level patient data cannot be shared.
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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. This study is not recruiting at the moment.
Chris Forrest, MD principal investigator
Children's Hospital of Philadelphia
Michelle Denburg, MD principal investigator
Children's Hospital of Philadelphia
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 Chronic Kidney Disease Stage 2 and Chronic Kidney Disease Stage 3, run by Children's Hospital of Philadelphia 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 16 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decline in estimated glomerular filtration rate (eGFR) (time frame: up to 18 months). 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 16 Aug 2024.