Trial Condition(s):
Renal function
Study to develop a tool to estimate the kidney function in databases without laboratory data
Bayer Identifier:
20325
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Scientific analyses are frequently performed on e.g. health insurance databases to study the usage and effectiveness of drugs in real life.
Kidney function is known to have an influence on a patients disease development and/or drug levels in blood.
However, often direct measures for kidney function are not available in databases.
This study plans to develop tools to classify the renal function of patients, which helps scientists to identify patient cohorts (groups of patients sharing same characteristics) for scientific analyses.
Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations US OPTUM CDM database Whippany, United States, 07981 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
An estimated glomerular filtration rate (eGFR) level prediction
Trial Type:
Observational
Intervention Type:
Other
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
4
Primary Outcome
- Performance of classification to predict eGFRFor numeric models cross-validated performance is measured as correlation via r*2. Class based performances are measured as cross-validated sensitivities given pre-defined false discovery rates with following definition for positives and negatives: Observed eGFR class X: * positive: eGFR measured at begin of time frame is in class X * negative: eGFR measured at begin of time frame is not in class X Class predicted by model: * positive: eGFR predicted is class X * negative: eGFR predicted is not class XTimeframe: From eGRF values starting and lasting 180d + 370d
Additional Information
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