Risk of Chronic Kidney Disease Progression



Status:Active, not recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2013
End Date:November 2018

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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.

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.

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)
We found this trial at
1
site
259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Mineola, NY
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