NCT02654756

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
623

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

5.5 years

First QC Date

January 11, 2016

Last Update Submit

February 17, 2023

Conditions

Keywords

Risk Assessment

Outcome Measures

Primary Outcomes (2)

  • Percentage difference in risk levels when comparing short term risk and lifetime risk in patients with CKD stage 3.

    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.

    2 to 5 years

Secondary Outcomes (1)

  • Assessment ESRD outcomes after risk stratification.

    2 to 5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Nephrology outpatient clinic

You may qualify if:

  • Evaluation at least once by a nephrologist in the past year.
  • Subjects must have recent pertinent laboratory data within the last 2 years.
  • documented creatinine values separated by at least 3 months

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Winthrop

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Candace Grant, MD

    NYU Winthrop

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 13, 2016

Study Start

May 1, 2013

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations