Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

Renal impairment is a common comorbidity in patients with diverse main underlying diseases and a pathology accompanying increasing age. Renal function might be an important modifier of treatment effects.

Population-based administrative claims databases are increasingly used in large-scale comparative outcomes studies of drug treatments. However, claims databases often lack information on laboratory tests results limiting their usefulness in Real-World Evidence(RWE) research of patients with renal impairment.

There is a need to develop methods for identification of patients with renal dysfunction from healthcare administrative claims-based proxies.

The main objective of this study is the development of algorithms/models to predict eGFR values and/or classes for patients at certain time point based on entries in claims database (demographic characteristics, clinical diagnoses, procedures and drug treatments) for a general population and a variety of use-cases (atrial fibrillation, coronary artery disease, type 2 diabetes mellitus patients sub-populations). To achieve this, modern data-driven machine learning techniques will be applied to discover relationships between renal status, measured by eGFR, and longitudinal patient-level data.

Evaluation of models' performance (out of sample validation, benchmark test, performance differences between eGFR value prediction algorithms and classification models tailored for the pre-defined eGFR classes) will be done as well. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03605810
Study type Observational
Source Bayer
Contact
Status Completed
Phase
Start date July 15, 2018
Completion date December 31, 2018

See also
  Status Clinical Trial Phase
Completed NCT01217736 - Direct Renin Inhibition and the Kidney Phase 1
Completed NCT04742816 - Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients Phase 4
Completed NCT01598987 - Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients. Phase 3
Completed NCT00992043 - Creatine Supplementation and Diabetes N/A
Recruiting NCT04334135 - The Influence of Mitochondrial-Derived Reactive Oxygen Species on Racial Disparities in Neurovascular Function N/A
Completed NCT04940260 - Soluble Factors and Renal Outcome in Preeclampsia
Recruiting NCT02288663 - Renal Function Assessment in the Elderly Using Plasma Creatinine Assay and Lean Body Mass Measurement N/A
Completed NCT01227213 - The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma N/A
Completed NCT03228563 - The Effect of Probiotics on Chronic Kidney Disease N/A
Completed NCT01680744 - The Effect of Therapeutic Hypothermia on Deceased Donor Renal Graft Outcomes - a Randomized Controlled Trial From the Region 5 Donor Management Goals Workgroup N/A
Completed NCT05179564 - Renal Function Assessment in Critically Ill Children N/A
Recruiting NCT05503147 - Sativex® and Gentamicin for Optimized Pharmagological Treatment in Older Patients (CanPan) Phase 1
Not yet recruiting NCT05813730 - Urinary Creatinine Excretion Time in the Neonatal Period N/A
Withdrawn NCT01802255 - Sevoflurane- Safety in Long-term Sedation Procedures Phase 3
Completed NCT01320722 - Study of Vitamin D and Uric Acid Lowering on Kidney and Blood Vessel Function N/A
Completed NCT01925235 - Analysis of Remote-ischemic Preconditioning Effects on Kidney Function N/A
Completed NCT01138241 - Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation
Completed NCT00634920 - Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients Phase 4
Recruiting NCT03170739 - Effects of Dexmedetomidine and Dopamine on Renal Function After Major Surgery Phase 4
Completed NCT00117390 - Evaluation of the Optimal Technique for Determination of Renal Function of Critically Ill Patients N/A