Chronic Kidney Disease Clinical Trial
Official title:
Risk of Chronic Kidney Disease Progression
NCT number | NCT02654756 |
Other study ID # | 13311 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | November 2018 |
Verified date | February 2023 |
Source | Winthrop University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 623 |
Est. completion date | November 2018 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | NYU Winthrop | Mineola | New York |
Lead Sponsor | Collaborator |
---|---|
Winthrop University Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage difference in risk levels when comparing short term risk and lifetime risk in patients with CKD stage 3. | 2 to 5 years | ||
Primary | 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 | Assessment ESRD outcomes after risk stratification. | 2 to 5 years |
Status | Clinical Trial | Phase | |
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