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Diagnosing Adverse Drug Reactions Registry (DART)

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ClinicalTrials.gov Identifier: NCT01970709
Recruitment Status : Unknown
Verified March 2015 by Renaissance RX.
Recruitment status was:  Active, not recruiting
First Posted : October 28, 2013
Last Update Posted : March 19, 2015
Sponsor:
Collaborator:
Syntactx
Information provided by (Responsible Party):
Renaissance RX

Study Description
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Brief 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 hospitalizations) associated with ADR.

Condition or disease
Genetics of Drug Metabolism

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250000 participants
Observational Model: Cohort
Target Follow-Up Duration: 60 Days
Official Title: DART Registry: Diagnosing Adverse Drug Reactions Registry
Study Start Date : November 2013
Estimated Primary Completion Date : November 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Frequency of genome-based PharmD recommendations to alter drug or dose. [ Time Frame: 60 days ]
  4. Emergency department visits and hospitalizations [ Time Frame: 60 days ]
    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.


Biospecimen Retention:   Samples With DNA
Buccal swab

Eligibility Criteria
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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
Male and female subjects over the age of 18, taking three or more medications, two of which are metabolized by the CYP450 pathway.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Contacts and Locations
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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): NCT01970709


Locations
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Sponsors and Collaborators
Renaissance RX
Syntactx
More Information
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Additional Information:

Publications:

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Responsible Party: Renaissance RX
ClinicalTrials.gov Identifier: NCT01970709    
Other Study ID Numbers: 2013-101
First Posted: October 28, 2013    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015
Keywords provided by Renaissance RX:
Adverse Drug Reactions
Emergency Department Visits
Hospitalizations
Pharmacogenomic
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders