NIH IGNITE Phase II: $42 Million Infused into Genomic Medicine Interventions

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The National Institutes of Health (NIH) moves into phase II of Implementing Genomics in Practice Network (IGNITE)–$42 million will be invested into genomic medicine clinical trial. With a goal of understanding the benefits, applicability and efficacy of genomic medicine interventions on pressing healthcare needs such as chronic pain, mental health and cardiovascular related therapeutic demands.  With clinical trials to commence in 2020, the nation’s federal research agency plans a series of genomic-related trials including blood pressure related research.

African American Have the Highest Recorded Blood Pressure in the World

The African American population has the highest recorded blood pressure in the world. The NIH’s first IGNITE clinical trial will examine treatment of high blood pressure, hypertension and chronic kidney disease.  Both hypertension and high blood pressure exacerbate end-stage kidney diseases, and all three conditions disproportionately afflict the African American population.  Recently the NIH offered a glimpse into two of the clinical trials forthcoming under the IGNITE phase II umbrella.

Trial #1: African Americans and APOL1 Mutation

The NIH informs two common mutations in the apolipoprotein (APOL1)  gene increase susceptibility to severe kidney disease by a factor of 10.  Investigators will utilize IGNITE funds to compare whether medical intervention provided to those tested for the APOL1 variant immediately after recruitment versus those tested three months later have subsequent benefit.

On this research endeavor, Simona Volpi, PhD, program director IGNITE pragmatic clinical trials, stated “Patients of African American ancestry might experience better management of high blood pressure and improved prevention of kidney disease caused by high blood pressure.  Treatment of depression and/or pain in patients regardless of race or ethnicity may be more effective and have fewer side effects when using a genomic approach to prescribing drugs for these conditions.”

Trial #2: Pain and Depression: Finding Safe and Effective Treatments Difficult

The NIH notes there are few clinically useful predictors for whether a depression treatment will be successful. Consequently, it has been challenging to uncover and develop effective pain and depression therapies.

The second IGNITE trial identified will be designed to test whether patients with acute post-surgical pain, chronic pain and depression have superior clinical outcomes if pharmacogenomics guide opioid and antidepressant prescriptions.  Pharmacogenomics, the study of how genes affect a person’s response to drugs, will be help guide opioid and antidepressant prescriptions.

Leveraging IGNITE Phase I Learnings

Phase I of IGNITE was funded by the National Human Genome Research Institute (NHGI) in 2013. This research program focused on challenges and possible solutions to incorporating genomic funded information into electronic health records. As IGNITE Phase II commences, the research network will develop and facilitate the application of genomics to diverse clinical care settings.

The IGNITE Network

The research sites associated with IGNITE include preeminent academic medical centers including:

  • Duke University
  • Vanderbilt University
  • Icahn School of Medicine at Mount Sinai

TrialSite News has developed an IGNITE dossier and would support others’ interest in these programs.