check_circleStudy Completed

Renal function

Bayer Identifier:

20325

ClinicalTrials.gov Identifier:

NCT03605810

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to develop a tool to estimate the kidney function in databases without laboratory data

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • To be included in the eGFR-population, patients have to have at least one recorded eGFR value in the OPTUM CDM database between January 1, 2007 and December 31, 2016, be adults (>18 years of age at the time of eGFR test) and have at least 370/180 days (180 days serves as sensitivity analysis) of continuous enrollment in medical and pharmacy insurance plans since eGFR test date.

Trial summary

Enrollment Goal
5132200
Trial Dates
July 2018 - December 2018
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
US OPTUM CDM databaseWhippany, 07981, United States

Primary Outcome

  • Performance of classification to predict eGFR
    For 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 X
    date_rangeTime Frame:
    From eGRF values starting and lasting 180d + 370d

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
N/A

Additional Information

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