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Interactive E-health Database for the Identification of Potential Interactions Among Drugs Prescribed to CKD Patient

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ClinicalTrials.gov Identifier: NCT04310501
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Evangelia Ntounousi, University of Ioannina

Brief Summary:
The aim of the current project is the development and implementation of an e-health database of drug interactions (drug-drug, drug-food, drug-alcohol and drug-herbal products interaction) to CKD patients in order to achieve a holistic approach to patient care and personalized medicine. The study will be conducted in the University of Ioannina (cooperation between the Department of Nephrology and the Laboratory of Physiology). Data will be collected form 150 CKD patients (Stages 1-5 pre-dialysis, undergoing dialysis, kidney transplantation). Sixty patients will be selected for the pilot study which will include blood and urine tests and specific polymorphism analysis (pharmacogenetic tests). Pilot implementation of the e-health database will be undertaken by health professionals of the Department of Nephrology (University Hospital of Ioannina) to test the system in realistic setting (usability, efficiency and efficacy) in order to make the necessary changes prior to full scale deployment.

Condition or disease
Renal Insufficiency, Chronic

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Development of an Interactive E-health Database Aimed to Identify Potential Interactions Among Drugs Prescribed to Chronic Kidney Disease (CKD) Patient
Actual Study Start Date : April 23, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Group/Cohort
CKD Patients

Patients (n=150) with CKD (Stages 1-5 pre-dialysis, undergoing dialysis, kidney transplantation) who fulfil the inclusion criteria from the Nephrology Dept and Renal Transplant Unit of the University Hospital of Ioannina.

Sixty patients will be selected for the pilot study which will include blood and urine tests and specific polymorphism analysis (pharmacogenetic tests)




Primary Outcome Measures :
  1. E-health database [ Time Frame: 1-12 months until completion of patients recruitment ]
    E-health database of drug interactions (drug-drug, drug-food, drug-alcohol and drug-herbal products interaction) to CKD patients in order to achieve a holistic approach to patient care and personalized medicine.


Biospecimen Retention:   Samples With DNA
Whole blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
150 patients with Chronic Kidney Disease (stages 1-5 pre-dialysis, kidney transplantation) from the Nephrology Department of University Hospital of Ioannina
Criteria

Inclusion Criteria:

  • Age>18 years
  • CKD diagnosis according to KDOQI Guidelines
  • absence of active malignancy
  • absence of decompensated heart failure New York Heart Association (NYHA) IV
  • absence of liver cirrhosis
  • patient's consent

Exclusion Criteria:

  • Age<18 years
  • active malignancy
  • decompensated heart failure NYHA IV
  • liver cirrhosis
  • patient's refusal to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04310501


Contacts
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Contact: Evangelia Ntounousi, PHD +302651099653 evangeldou@gmail.com

Locations
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Greece
University Hospital of Ioannina Recruiting
Ioánnina, Greece, 45110
Contact: Evangelia Dounousi, PHD    +302651099653    evangeldou@gmail.com   
Sponsors and Collaborators
University of Ioannina
Investigators
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Principal Investigator: Evangelia Ntounousi, PHD University of Ioannina
Publications:
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Responsible Party: Evangelia Ntounousi, Assistant Professor, University of Ioannina
ClinicalTrials.gov Identifier: NCT04310501    
Other Study ID Numbers: RESCOMUOI82476
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evangelia Ntounousi, University of Ioannina:
Drug Interactions
Polymorphism, Genetic
Pharmacogenetics
Databases, Pharmaceutical
Additional relevant MeSH terms:
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Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases