Chronic Kidney DiseaseNCT02654756
Risk of Chronic Kidney Disease Progression
An observational study of Chronic Kidney Disease and End Stage Renal Disease, run by Winthrop University Hospital at 1 site in United States.
Trial summary
While there are proven therapies that slow CKD progression, these therapies can at times be harmful and costly. The ability to accurately predict the risk of CKD progression to ESRD would be extremely valuable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, End Stage Renal Disease
- How many people
- 623 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Nov 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Nephrology outpatient clinic
Who may be able to join
- Evaluation at least once by a nephrologist in the past year.
- Subjects must have recent pertinent laboratory data within the last 2 years.
- 2 documented creatinine values separated by at least 3 months
Who cannot join
- Deceased patients
- estimated GFR < 15ml/min
- Patients with Acute Renal Failure (ARF)
Trial locations and contacts
1 site in 1 country.
About this study
While there are proven therapies that slow CKD progression, these therapies can at times be harmful and costly. The ability to accurately predict the risk of CKD progression to ESRD would be extremely valuable. The short term versus lifetime risk of CKD progression should be taken into account when making risk based clinical decisions. In a representative CKD practice, the investigators compared the short term and lifetime risk assessment in our stage 3 CKD patients to determine whether decisions based on a short term risk assessment would underestimate the lifetime risk of CKD progression. The investigators also applied the short term risk assessment to our stage 4 CKD patients to determine the frequency with which ESRD risk may be overestimated in CKD stage 4.
Read the detailed description
In the US, more than 20 million adults have Chronic Kidney Disease (CKD) and are therefore at increased risk for cardiovascular disease (CVD) and progression to end-stage renal disease (ESRD) as compared to those without CKD. While there have been many substantiated therapies that slow the progression of CKD and improve overall outcomes, clinical decision making is difficult due to the variability of progression of CKD and increased risk of cardiovascular mortality. As these therapies can at times be harmful and costly, the ability to accurately predict the risk of CKD progression would be extremely valuable. Kidney Disease: Improving Global Outcomes (KDIGO) recently incorporated a risk scale that was a reflection of a composite of 5 CKD outcomes: all-cause mortality, CVD mortality, ESRD, acute kidney injury (AKI) and progression of CKD. It is in its infancy and guidelines reflecting this risk stratification have yet to be determined. Several risk prediction tools that have been validated in specific CKD populations but none have been widely accepted and implemented in the clinical setting. These tools incorporate multiple risk factors as compared to the KDIGO risk categories which uses eGFR and urine albumin to creatinine ratio (ACR) to determine the risk of the above mention composite. The KDIGO scale does not take age into account and this may have a major effect on risk stratification. One risk assessment tool that does take the patients' age into account is the risk equation developed from the paper by Tangri N et al. (JAMA 2011;305(15):1553-1559). This equation uses age, sex, serum calcium levels, serum phosphate levels, serum albumin levels and serum bicarbonate levels in addition to GFR and UCR to calculate the risk of progression to ESRD requiring dialysis or transplantation. This risk calculator reflects short term risk as it supplies a 2yr and 5yr progression risk for CKD stage 3 and 4 patients. A Lifetime risk estimator (adjusted for competing risk of death) that uses age, sex and eGFR to define an age and sex specific 10, 20, 30, 40 and lifetime risk for CKD progression was provided by a study by Turin TC et al (J Am Soc Nephrol 2012;23(9):1569-1578). The purpose of this study is to examine the effect of using the 2yr, 5yr and lifetime risk assessment tools on a population of individuals with stage 3 and 4 CKD.
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease
- Keywords
- Risk Assessment
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage difference in risk levels when comparing short term risk and lifetime risk in patients with CKD stage 3.
Measured: 2 to 5 years
Percentage of patients with CKD stage 4 in low, intermediate and high risk categories after assessing short term risk in patients with CKD stage 4.
Measured: 2 to 5 years
Secondary outcomes (1)
Assessment ESRD outcomes after risk stratification.
Measured: 2 to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startMay 2013
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Candace Grant, MD, Principal investigator, NYU Winthrop
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654756
- Sponsor's protocol ID
- 13311
- Status last verified
- Feb 2023
- First submitted
- 11 Jan 2016
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Chronic Kidney Disease Progression
- ClinicalTrials.gov ID
- NCT02654756
- Acronym / sponsor ID
- 13311
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease
- Keywords
- Risk Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 13 Jan 2016 (estimated)
- 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.
While there are proven therapies that slow CKD progression, these therapies can at times be harmful and costly. The ability to accurately predict the risk of CKD progression to ESRD would be extremely valuable. The short term versus lifetime risk of CKD progression should be taken into account when making risk based clinical decisions. In a representative CKD practice, the investigators compared the short term and lifetime risk assessment in our stage 3 CKD patients to determine whether decisions based on a short term risk assessment would underestimate the lifetime risk of CKD progression. The investigators also applied the short term risk assessment to our stage 4 CKD patients to determine the frequency with which ESRD risk may be overestimated in CKD stage 4.
Detailed description
In the US, more than 20 million adults have Chronic Kidney Disease (CKD) and are therefore at increased risk for cardiovascular disease (CVD) and progression to end-stage renal disease (ESRD) as compared to those without CKD. While there have been many substantiated therapies that slow the progression of CKD and improve overall outcomes, clinical decision making is difficult due to the variability of progression of CKD and increased risk of cardiovascular mortality. As these therapies can at times be harmful and costly, the ability to accurately predict the risk of CKD progression would be extremely valuable. Kidney Disease: Improving Global Outcomes (KDIGO) recently incorporated a risk scale that was a reflection of a composite of 5 CKD outcomes: all-cause mortality, CVD mortality, ESRD, acute kidney injury (AKI) and progression of CKD. It is in its infancy and guidelines reflecting this risk stratification have yet to be determined. Several risk prediction tools that have been validated in specific CKD populations but none have been widely accepted and implemented in the clinical setting. These tools incorporate multiple risk factors as compared to the KDIGO risk categories which uses eGFR and urine albumin to creatinine ratio (ACR) to determine the risk of the above mention composite. The KDIGO scale does not take age into account and this may have a major effect on risk stratification. One risk assessment tool that does take the patients' age into account is the risk equation developed from the paper by Tangri N et al. (JAMA 2011;305(15):1553-1559). This equation uses age, sex, serum calcium levels, serum phosphate levels, serum albumin levels and serum bicarbonate levels in addition to GFR and UCR to calculate the risk of progression to ESRD requiring dialysis or transplantation. This risk calculator reflects short term risk as it supplies a 2yr and 5yr progression risk for CKD stage 3 and 4 patients. A Lifetime risk estimator (adjusted for competing risk of death) that uses age, sex and eGFR to define an age and sex specific 10, 20, 30, 40 and lifetime risk for CKD progression was provided by a study by Turin TC et al (J Am Soc Nephrol 2012;23(9):1569-1578). The purpose of this study is to examine the effect of using the 2yr, 5yr and lifetime risk assessment tools on a population of individuals with stage 3 and 4 CKD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nephrology outpatient clinic
Key inclusion criteria (3 listed)
- Evaluation at least once by a nephrologist in the past year.
- Subjects must have recent pertinent laboratory data within the last 2 years.
- 2 documented creatinine values separated by at least 3 months
Key exclusion criteria (3 listed)
- Deceased patients
- estimated GFR < 15ml/min
- Patients with Acute Renal Failure (ARF)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage difference in risk levels when comparing short term risk and lifetime risk in patients with CKD stage 3.
Time frame: 2 to 5 years
Percentage of patients with CKD stage 4 in low, intermediate and high risk categories after assessing short term risk in patients with CKD stage 4.
Time frame: 2 to 5 years
1 secondary outcome
Assessment ESRD outcomes after risk stratification.
Time frame: 2 to 5 years
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 21 Feb 2023.
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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.
Candace Grant, MD principal investigator
NYU Winthrop
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 and End Stage Renal Disease, run by Winthrop University Hospital 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 3 inclusion and 3 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 21 Feb 2023. 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?
Percentage difference in risk levels when comparing short term risk and lifetime risk in patients with CKD stage 3. (time frame: 2 to 5 years). The study lists 2 primary outcomes in all. 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 21 Feb 2023.