Genetics of Drug MetabolismDARTNCT01970709
Diagnosing Adverse Drug Reactions Registry
An observational study of Genetics of Drug Metabolism, run by Renaissance RX at 49 sites in United States.
Trial summary
This multicenter Registry is to assess whether the use of pharmacogenomic data results in a meaningful change in a subject's drug or dose regimen. In addition, the Registry will evaluate the relationship between adverse drug reactions (ADR) and genotype and assess resource utilization (emergency department visits and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genetics of Drug Metabolism
- How many people
- 250,000 participants
- Where
- 49 sitesUnited States
- Study dates
- Nov 2013to Nov 2015
- How long will I take part?
- 60 Days
- 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: Male and female subjects over the age of 18, taking three or more medications, two of which are metabolized by the CYP450 pathway.
Who may be able to join
- Subject has care coordinated at the treating physician's outpatient clinic;
- Subject has provided written informed consent;
- Subject is taking at least three (3) regularly scheduled medications, excluding as needed (PRN) medications, over the counter medications and nutritional supplements; two (2) of which are known to be affected by genetic allelic variation.
- Subject's treating physician has a clinical suspicion that the subject is experiencing adverse signs or symptoms related to a prescribed medication or is not achieving the intended effect from the medication.
Who cannot join
- Subject has a history of chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5;
- Subject has a history of abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) >1.5x normal, or suspected cirrhosis);
- Subject has a history of malabsorption (short gut syndrome);
- Subject has a history of any gastric or small bowel surgery;
- Subject is currently hospitalized;
- Subject is currently being treated with intravenous medication;
- Subject underwent prior pharmacogenomic testing with results reported within the last 12 months.
- Subjects may be eligible within 60 days from the date of pharmacogenomic testing.
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
United States49 sites
Internal Medicine Specialists of Alamogordo, P.C.
Alamogordo, New Mexico, 88310
Lovelace Rehabilitation Hospital
Albuquerque, New Mexico, 87102
Sage Neuroscience Center
Albuquerque, New Mexico, 87109
Geriatrics Associates, PAC
Albuquerque, New Mexico, 87113
Prime Healthcare - Anthony Roselli MD
Avon, Connecticut, 06001
Edwards Lake Medical Center
Birmingham, Alabama, 35235
Boulder Medical Center
Boulder, Colorado, 80304
Larry F Berman MD PC
Charlotte, North Carolina, 28210-0106
Roman Medical Group
Columbus, Georgia, 31904
Comprehensive Pain Center
Columbus, Ohio, 43213
Knightsbridge Internal Medicine and Cardiology Associates, Inc
Columbus, Ohio, 43214
Gateway Health and Wellness LLC
Columbus, Ohio, 43215
Continental Research Network
Doral, Florida, 33126
Lakewood Pediatrics and Family Medicine
Durham, North Carolina, 27704
Easton Cardiovascular Associates
Easton, Pennsylvania, 18042
Union Square Medical Associates, PC
Elizabeth, New Jersey, 07208
Emporia Medical Associates
Emporia, Virginia, 23847
Mark A. Sanders, DO
Fort Worth, Texas, 76107
Carolina Urology Partners
Gastonia, North Carolina, 28054
Gerald Harris MD
Glendale, Arizona, 85308
Healthy Heart Cardiology
Grandville, Michigan, 49418
Carolina Neurosurgery and Spine Associates
Greensboro, North Carolina, 27401
Carolina Center For Advanced Management Of Pain
Greenville, South Carolina, 29601
Wellness Medicine
Hampton, Georgia, 30228
Isabel C Vigil MD
Las Cruces, New Mexico, 88005
Women's Care Center
Lexington, Kentucky, 40503
Olga Voroshilovsky
Los Angeles, California, 90048
United Medical PC
Lyndhurst, New Jersey, 07071
Ocmulgee Physicians
Macon, Georgia, 31201
Macon Family Health Center Inc.
Macon, Georgia, 31204
Robert E Barkett Jr MD
Mansfield, Ohio, 44907
Midwestern Internal Medicine Associates (MIMA)
Marion, Ohio, 43302
Latin Foundation for Health
Miami, Florida, 33144
Parkway Cardiology Associates
Oak Ridge, Tennessee, 37830
Primary Health Associates
Orland Park, Illinois, 60467
Institute for Regenerative Medicine and Clinical Research
Pasadena, California, 91105
Holland Center for Family Health
Peoria, Arizona, 85381
AZ Pain Center
Phoenix, Arizona, 85032
Stonegate Family Health
Reynoldsburg, Ohio, 43068
Your Personal Physician
Rome, Georgia, 30161
Valley Health Care
Rome, Georgia, 30165
Dr. B. Abraham PC
Snellville, Georgia, 30039
Heart Cardiology Consultants
Southfield, Michigan, 48075
Candler Internal Medicine
Statesboro, Georgia, 30458
Primary Care Associates, P.A.
Stuart, Florida, 34994
Colonial Family Practice
Sumter, South Carolina, 29150
Palmetto Adult Medicine
Sumter, South Carolina, 29150
Primary Care Associates - Unity
Tallmadge, Ohio, 44278
Washington Pain Center
Washington D.C., District of Columbia, 20016
About this study
Official title: DART Registry: Diagnosing Adverse Drug Reactions Registry
This multicenter Registry is to assess whether the use of pharmacogenomic data results in a meaningful change in a subject's drug or dose regimen. In addition, the Registry will evaluate the relationship between adverse drug reactions (ADR) and genotype and assess resource utilization (emergency department visits and hospitalizations) associated with ADR.
- Conditions
- Genetics of Drug Metabolism
- Keywords
- Adverse Drug Reactions, Emergency Department Visits, Hospitalizations, Pharmacogenomic
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of meaningful change in drug regimen
The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each subject when:
- A genotype known to affect a drug the subject is taking is identified, and
- The subject's treating physician makes at least one drug regimen change in concordance with the PharmD recommendations.
Measured: 60 days
Secondary outcomes (4)
Change in the regimen of drugs controlled by genes of interest over the 12 months prior to enrollment and change in the regimen of drugs controlled by genes of interest over the 60 days following receipt of pharmacogenetic test results.
Measured: 60 days
Number of ADR per month over the 12 months prior to enrollment and number of ADR per month over the 60 days following receipt of pharmacogenomic test results.
Measured: 60 days
Frequency of genome-based PharmD recommendations to alter drug or dose.
Measured: 60 days
Emergency department visits and hospitalizations
Emergency department visits over the 12 months prior to enrollment, emergency department visits over the 60 days following receipt of test results, hospitalizations over the 12 months prior to enrollment, and hospitalizations over the 60 days following receipt of test results.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Genetics of Drug MetabolismStudies 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
- Cohort
- Enrolment
- 250,000 participants (estimated)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- Renaissance RX
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970709
- Sponsor's protocol ID
- 2013-101
- Acronym
- DART
- Status last verified
- Mar 2015
- First submitted
- 22 Oct 2013
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Onder G, Petrovic M, Tangiisuran B, Meinardi MC, Markito-Notenboom WP, Somers A, Rajkumar C, Bernabei R, van der Cammen TJ. Development and validation of a score to assess risk of adverse drug reactions among in-hospital patients 65 years or older: the GerontoNet ADR risk score. Arch Intern Med. 2010 Jul 12;170(13):1142-8. doi: 10.1001/archinternmed.2010.153.
PubMed 20625022Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998 Apr 15;279(15):1200-5. doi: 10.1001/jama.279.15.1200.
PubMed 9555760Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011 Nov 24;365(21):2002-12. doi: 10.1056/NEJMsa1103053.
PubMed 22111719Mallet 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 17630042Epstein RS, Moyer TP, Aubert RE, O Kane DJ, Xia F, Verbrugge RR, Gage BF, Teagarden JR. Warfarin genotyping reduces hospitalization rates results from the MM-WES (Medco-Mayo Warfarin Effectiveness study). J Am Coll Cardiol. 2010 Jun 22;55(25):2804-12. doi: 10.1016/j.jacc.2010.03.009. Epub 2010 Apr 8.
PubMed 20381283Wang L, McLeod HL, Weinshilboum RM. Genomics and drug response. N Engl J Med. 2011 Mar 24;364(12):1144-53. doi: 10.1056/NEJMra1010600. No abstract available.
PubMed 21428770Aronson JK. Adverse drug reactions--no farewell to harms. Br J Clin Pharmacol. 2007 Feb;63(2):131-5. doi: 10.1111/j.1365-2125.2006.02860.x. No abstract available.
PubMed 17274787Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000 Oct 7;356(9237):1255-9. doi: 10.1016/S0140-6736(00)02799-9.
PubMed 11072960Gage BF, Eby C, Johnson JA, Deych E, Rieder MJ, Ridker PM, Milligan PE, Grice G, Lenzini P, Rettie AE, Aquilante CL, Grosso L, Marsh S, Langaee T, Farnett LE, Voora D, Veenstra DL, Glynn RJ, Barrett A, McLeod HL. Use of pharmacogenetic and clinical factors to predict the therapeutic dose of warfarin. Clin Pharmacol Ther. 2008 Sep;84(3):326-31. doi: 10.1038/clpt.2008.10. Epub 2008 Feb 27.
PubMed 18305455International Warfarin Pharmacogenetics Consortium; Klein TE, Altman RB, Eriksson N, Gage BF, Kimmel SE, Lee MT, Limdi NA, Page D, Roden DM, Wagner MJ, Caldwell MD, Johnson JA. Estimation of the warfarin dose with clinical and pharmacogenetic data. N Engl J Med. 2009 Feb 19;360(8):753-64. doi: 10.1056/NEJMoa0809329.
PubMed 19228618Garcia DA, Lopes RD, Hylek EM. New-onset atrial fibrillation and warfarin initiation: high risk periods and implications for new antithrombotic drugs. Thromb Haemost. 2010 Dec;104(6):1099-105. doi: 10.1160/TH10-07-0491. Epub 2010 Sep 30.
PubMed 20886196Meckley LM, Gudgeon JM, Anderson JL, Williams MS, Veenstra DL. A policy model to evaluate the benefits, risks and costs of warfarin pharmacogenomic testing. Pharmacoeconomics. 2010;28(1):61-74. doi: 10.2165/11318240-000000000-00000.
PubMed 20014877Relling MV, Klein TE. CPIC: Clinical Pharmacogenetics Implementation Consortium of the Pharmacogenomics Research Network. Clin Pharmacol Ther. 2011 Mar;89(3):464-7. doi: 10.1038/clpt.2010.279. Epub 2011 Jan 26.
PubMed 21270786Gandhi TK, Weingart SN, Borus J, Seger AC, Peterson J, Burdick E, Seger DL, Shu K, Federico F, Leape LL, Bates DW. Adverse drug events in ambulatory care. N Engl J Med. 2003 Apr 17;348(16):1556-64. doi: 10.1056/NEJMsa020703.
PubMed 12700376Huhtakangas J, Tetri S, Juvela S, Saloheimo P, Bode MK, Hillbom M. Effect of increased warfarin use on warfarin-related cerebral hemorrhage: a longitudinal population-based study. Stroke. 2011 Sep;42(9):2431-5. doi: 10.1161/STROKEAHA.111.615260. Epub 2011 Jul 28.
PubMed 21799168
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DART Registry: Diagnosing Adverse Drug Reactions Registry
- ClinicalTrials.gov ID
- NCT01970709
- Acronym / sponsor ID
- DART / 2013-101
- Conditions
- Genetics of Drug Metabolism
- Keywords
- Adverse Drug Reactions, Emergency Department Visits, Hospitalizations, Pharmacogenomic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250,000 participants (estimated)
- Lead sponsor
- Renaissance RXIndustry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Study start
- Nov 2013
- Primary completion
- Nov 2015 (estimated)
- First posted
- 28 Oct 2013 (estimated)
- 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.
This multicenter Registry is to assess whether the use of pharmacogenomic data results in a meaningful change in a subject's drug or dose regimen. In addition, the Registry will evaluate the relationship between adverse drug reactions (ADR) and genotype and assess resource utilization (emergency department visits and hospitalizations) associated with ADR.
Study design
- Observational model
- Cohort
- Target follow-up
- 60 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects over the age of 18, taking three or more medications, two of which are metabolized by the CYP450 pathway.
Key inclusion criteria (4 listed)
- Subject has care coordinated at the treating physician's outpatient clinic;
- Subject has provided written informed consent;
- Subject is taking at least three (3) regularly scheduled medications, excluding as needed (PRN) medications, over the counter medications and nutritional supplements; two (2) of which are known to be affected by genetic allelic variation.
- Subject's treating physician has a clinical suspicion that the subject is experiencing adverse signs or symptoms related to a prescribed medication or is not achieving the intended effect from the medication.
Key exclusion criteria (8 listed)
- Subject has a history of chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5;
- Subject has a history of abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) >1.5x normal, or suspected cirrhosis);
- Subject has a history of malabsorption (short gut syndrome);
- Subject has a history of any gastric or small bowel surgery;
- Subject is currently hospitalized;
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
Occurrence of meaningful change in drug regimen
Time frame: 60 days
The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each subject when: * A genotype known to affect a drug the subject is taking is identified, and * The subject's treating physician makes at least one drug regimen change in concordance with the PharmD recommendations.
4 secondary outcomes
Change in the regimen of drugs controlled by genes of interest over the 12 months prior to enrollment and change in the regimen of drugs controlled by genes of interest over the 60 days following receipt of pharmacogenetic test results.
Time frame: 60 days
Number of ADR per month over the 12 months prior to enrollment and number of ADR per month over the 60 days following receipt of pharmacogenomic test results.
Time frame: 60 days
Frequency of genome-based PharmD recommendations to alter drug or dose.
Time frame: 60 days
Emergency department visits and hospitalizations
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Background: PubMed 20625022Onder G, Petrovic M, Tangiisuran B, Meinardi MC, Markito-Notenboom WP, Somers A, Rajkumar C, Bernabei R, van der Cammen TJ. Development and validation of a score to assess risk of adverse drug reactions among in-hospital patients 65 years or older: the GerontoNet ADR risk score. Arch Intern Med. 2010 Jul 12;170(13):1142-8. doi: 10.1001/archinternmed.2010.153.
- Background: PubMed 9555760Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998 Apr 15;279(15):1200-5. doi: 10.1001/jama.279.15.1200.
- Background: PubMed 22111719Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011 Nov 24;365(21):2002-12. doi: 10.1056/NEJMsa1103053.
- 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 20381283Epstein RS, Moyer TP, Aubert RE, O Kane DJ, Xia F, Verbrugge RR, Gage BF, Teagarden JR. Warfarin genotyping reduces hospitalization rates results from the MM-WES (Medco-Mayo Warfarin Effectiveness study). J Am Coll Cardiol. 2010 Jun 22;55(25):2804-12. doi: 10.1016/j.jacc.2010.03.009. Epub 2010 Apr 8.
- Background: PubMed 21428770Wang L, McLeod HL, Weinshilboum RM. Genomics and drug response. N Engl J Med. 2011 Mar 24;364(12):1144-53. doi: 10.1056/NEJMra1010600. No abstract available.
- Background: PubMed 17274787Aronson JK. Adverse drug reactions--no farewell to harms. Br J Clin Pharmacol. 2007 Feb;63(2):131-5. doi: 10.1111/j.1365-2125.2006.02860.x. No abstract available.
- Background: PubMed 11072960Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000 Oct 7;356(9237):1255-9. doi: 10.1016/S0140-6736(00)02799-9.
- Background: PubMed 18305455Gage BF, Eby C, Johnson JA, Deych E, Rieder MJ, Ridker PM, Milligan PE, Grice G, Lenzini P, Rettie AE, Aquilante CL, Grosso L, Marsh S, Langaee T, Farnett LE, Voora D, Veenstra DL, Glynn RJ, Barrett A, McLeod HL. Use of pharmacogenetic and clinical factors to predict the therapeutic dose of warfarin. Clin Pharmacol Ther. 2008 Sep;84(3):326-31. doi: 10.1038/clpt.2008.10. Epub 2008 Feb 27.
- Background: PubMed 19228618International Warfarin Pharmacogenetics Consortium; Klein TE, Altman RB, Eriksson N, Gage BF, Kimmel SE, Lee MT, Limdi NA, Page D, Roden DM, Wagner MJ, Caldwell MD, Johnson JA. Estimation of the warfarin dose with clinical and pharmacogenetic data. N Engl J Med. 2009 Feb 19;360(8):753-64. doi: 10.1056/NEJMoa0809329.
- Background: PubMed 20886196Garcia DA, Lopes RD, Hylek EM. New-onset atrial fibrillation and warfarin initiation: high risk periods and implications for new antithrombotic drugs. Thromb Haemost. 2010 Dec;104(6):1099-105. doi: 10.1160/TH10-07-0491. Epub 2010 Sep 30.
- Background: PubMed 20014877Meckley LM, Gudgeon JM, Anderson JL, Williams MS, Veenstra DL. A policy model to evaluate the benefits, risks and costs of warfarin pharmacogenomic testing. Pharmacoeconomics. 2010;28(1):61-74. doi: 10.2165/11318240-000000000-00000.
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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.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetics of Drug Metabolism, run by Renaissance RX at 49 sites in United States.
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 4 inclusion and 8 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 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of meaningful change in drug regimen (time frame: 60 days). 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 NCT01970709, which also lists 15 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 19 Mar 2015.