Renal Insufficiency, ChronicNCT04310501
Interactive E-health Database for the Identification of Potential Interactions Among Drugs Prescribed to CKD Patient
An observational study of Renal Insufficiency, Chronic, run by University of Ioannina at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- 23 Apr 2020to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 150 patients with Chronic Kidney Disease (stages 1-5 pre-dialysis, kidney transplantation) from the Nephrology Department of University Hospital of Ioannina
Who may be able to join
- 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
Who cannot join
- Age<18 years
- active malignancy
- decompensated heart failure NYHA IV
- liver cirrhosis
- patient's refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Ioannina
Ioannina, 45110
Evangelia Dounousi, PHD, +302651099653, evangeldou@gmail.com
About this study
Official title: Development of an Interactive E-health Database Aimed to Identify Potential Interactions Among Drugs Prescribed to Chronic Kidney Disease (CKD) Patient
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.
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Drug Interactions, Polymorphism, Genetic, Pharmacogenetics, Databases, Pharmaceutical
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
E-health database
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.
Measured: 1-12 months until completion of patients recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start23 Apr 2020
- Primary completionSep 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evangelia Ntounousi, University of Ioannina
- Investigators
- Evangelia Ntounousi, PHD, Principal investigator, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310501
- Sponsor's protocol ID
- RESCOMUOI82476
- Status last verified
- May 2021
- First submitted
- 9 Mar 2020
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Andersson ML, Bottiger Y, Lindh JD, Wettermark B, Eiermann B. Impact of the drug-drug interaction database SFINX on prevalence of potentially serious drug-drug interactions in primary health care. Eur J Clin Pharmacol. 2013 Mar;69(3):565-71. doi: 10.1007/s00228-012-1338-y. Epub 2012 Jul 1.
PubMed 22752671Classen DC, Phansalkar S, Bates DW. Critical drug-drug interactions for use in electronic health records systems with computerized physician order entry: review of leading approaches. J Patient Saf. 2011 Jun;7(2):61-5. doi: 10.1097/PTS.0b013e31821d6f6e.
PubMed 21577077Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. doi: 10.1001/jama.298.17.2038.
PubMed 17986697Mallet L, Spinewine A, Huang A. The challenge of managing drug interactions in elderly people. Lancet. 2007 Jul 14;370(9582):185-191. doi: 10.1016/S0140-6736(07)61092-7.
PubMed 17630042Meyer UA. Pharmacogenetics and adverse drug reactions. Lancet. 2000 Nov 11;356(9242):1667-71. doi: 10.1016/S0140-6736(00)03167-6.
PubMed 11089838
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Interactive E-health Database Aimed to Identify Potential Interactions Among Drugs Prescribed to Chronic Kidney Disease (CKD) Patient
- ClinicalTrials.gov ID
- NCT04310501
- Acronym / sponsor ID
- RESCOMUOI82476
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Drug Interactions, Polymorphism, Genetic, Pharmacogenetics, Databases, Pharmaceutical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 patients with Chronic Kidney Disease (stages 1-5 pre-dialysis, kidney transplantation) from the Nephrology Department of University Hospital of Ioannina
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Age<18 years
- active malignancy
- decompensated heart failure NYHA IV
- liver cirrhosis
- patient's refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Background: PubMed 22752671Andersson ML, Bottiger Y, Lindh JD, Wettermark B, Eiermann B. Impact of the drug-drug interaction database SFINX on prevalence of potentially serious drug-drug interactions in primary health care. Eur J Clin Pharmacol. 2013 Mar;69(3):565-71. doi: 10.1007/s00228-012-1338-y. Epub 2012 Jul 1.
- Background: PubMed 21577077Classen DC, Phansalkar S, Bates DW. Critical drug-drug interactions for use in electronic health records systems with computerized physician order entry: review of leading approaches. J Patient Saf. 2011 Jun;7(2):61-5. doi: 10.1097/PTS.0b013e31821d6f6e.
- Background: PubMed 17986697Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. doi: 10.1001/jama.298.17.2038.
- Background: PubMed 17630042Mallet L, Spinewine A, Huang A. The challenge of managing drug interactions in elderly people. Lancet. 2007 Jul 14;370(9582):185-191. doi: 10.1016/S0140-6736(07)61092-7.
- Background: PubMed 11089838Meyer UA. Pharmacogenetics and adverse drug reactions. Lancet. 2000 Nov 11;356(9242):1667-71. doi: 10.1016/S0140-6736(00)03167-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evangelia Ntounousi, PHD principal investigator
University of Ioannina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency, Chronic, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evangelia Ntounousi, PHD (+302651099653, evangeldou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
E-health database (time frame: 1-12 months until completion of patients recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04310501, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.