Diagnosing Adverse Drug Reactions Registry (DART)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Renaissance RX
Sponsor:
Collaborator:
Syntactx
Information provided by (Responsible Party):
Renaissance RX
ClinicalTrials.gov Identifier:
NCT01970709
First received: October 22, 2013
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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
Genetics of Drug Metabolism

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Target Follow-Up Duration: 60 Days
Official Title: DART Registry: Diagnosing Adverse Drug Reactions Registry

Further study details as provided by Renaissance RX:

Primary Outcome Measures:
  • Occurrence of meaningful change in drug regimen [ Time Frame: 60 days ] [ Designated as safety issue: No ]

    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:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Frequency of genome-based PharmD recommendations to alter drug or dose. [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Emergency department visits and hospitalizations [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 250000
Study Start Date: November 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970709

Contacts
Contact: Karthik Kasirajan kkasirajan@renrx.com
Contact: Sophia Ly sly@syntactx.com

  Show 50 Study Locations
Sponsors and Collaborators
Renaissance RX
Syntactx
  More Information

Publications:

Responsible Party: Renaissance RX
ClinicalTrials.gov Identifier: NCT01970709     History of Changes
Other Study ID Numbers: 2013-101
Study First Received: October 22, 2013
Last Updated: October 7, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Renaissance RX:
Adverse Drug Reactions
Emergency Department Visits
Hospitalizations
Pharmacogenomic

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on October 19, 2014