Risk of Chronic Kidney Disease Progression

February 17, 2023 updated by: Winthrop University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
623

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Mineola, New York, United States, 11501
        • NYU Winthrop

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Nephrology outpatient clinic

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Deceased patients
  • estimated GFR < 15ml/min
  • Patients with Acute Renal Failure (ARF)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
2 to 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Assessment ESRD outcomes after risk stratification.
Time Frame: 2 to 5 years
2 to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Winthrop University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Candace Grant, MD, NYU Winthrop

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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