Navigation Links
FDA awards $2.25M grant to study immunosuppresive drug in high-risk patients
Date:11/7/2013

CINCINNATITransplant researchers at the University of Cincinnati (UC) have received a grant from the U.S. Food and Drug Administration to study the safety and efficacy of a generic immunosuppressive drug in high-risk transplant patients.

Rita Alloway, PharmD, UC research professor of medicine and director of transplant clinical research within the UC Department of Internal Medicine, received a $2.25 million FDA grant to run two clinical trials studying the effects of immunosuppressant tacrolimus (Prograf and generics) in high-risk transplant patients.

Tacrolimus is a "cornerstone drug" in post-transplant immunosuppression, used after transplant to reduce the activity of the patient's immune system and lower the risk of rejection. Generic versions were introduced in 2009. Currently Alloway estimates more than 70 percent of transplant patients are dispensed generic tacrolimus.

"The largest concern for clinicians is the switchability between various generics," says Alloway. "When patients receive their prescription, they could be getting medication from different manufacturers each month. Most immunosuppressant drugs require individualized dosing and careful management to ensure the proper blood concentrations are maintainedtoo high exposure to these drugs increases the risk of toxicity, over-immunosuppression and cancer in patents. Too low exposure may lead to rejection of the organ by the patient's immune system."

The three-year grant will support retrospective and prospective studies in high-risk transplant recipients who have converted from branded tacrolimus to a generic version.

In the retrospective study, transplant recipients will be assessed one year prior and one year post conversion to the generic, with researchers assessing their tacrolimus dose changes, incidence of rejection, hospital admission, changes in renal function and changes in transplanted organ function.

The prospective study will compare the bioavailability and steady-state pharmacokinetics of six tacrolimus formulations in a six-way cross-over study. This study will compare patients who express the CYP3A5 enzyme and those who do not, as CYP3A5 expressors have been shown to require larger doses of tacrolimus to attain therapeutic blood concentrations.

Preliminary data from Alloway's tacrolimus research has suggested a link between CYP3A5 expression and peak tacrolimus levels after dosing in generic tacrolimus formulations.

"This study will analyze an enriched patient population based upon genetic factors which predispose the patient to be high risk and most likely to experience problems with generic switching if problems exist," states Alloway.

In 2012, Alloway received a $2.7 million grant from the FDA to study whether the two most disparate generic versions of tacrolimus are bioequivalent to the branded, or innovator, version of the drug in stable transplant patients.

"The results of these studies should address public concerns regarding the use of generic tacrolimus formulations in transplant recipients and provide the transplant clinician and recipients with objective data to address their concerns," she says.


'/>"/>

Contact: Katy Cosse
kathryn.cosse@uc.edu
513-558-0207
University of Cincinnati Academic Health Center
Source:Eurekalert

Related medicine news :

1. T.E.N. Announces Winners of the ISE® North America Awards
2. The Global Awards World’s Best Healthcare Advertising Hosts Celebrations in New York City & Sydney, Australia
3. The Optical Society Presents Awards to Winners of Its Inaugural ‘Enabled by Optics’
4. Wells Fargo Supports Hospice Care as Diamond Sponsor of Pathways Hospice Awards Breakfast
5. DailyGossip.org Reviews "Face Fitness Formula" and Awards the Latest Guide Released by Face Fitness Center
6. Force Marketing Honored in Inc. Magazine Hire Power Awards for 2013
7. The Home Depot Foundation Awards Swords to Plowshares $24,000 to Renovate Housing for Veteran Families
8. Barton Publishing Honored as Silver Winner in 2013 Golden Bridge Awards “Best Customer Satisfaction Program of the Year”
9. National Robotics Initiative Awards provide $7 million for Carnegie Mellon research projects
10. American Eurocopter Awards Honor Leaders in Air Medical Safety
11. IPM receives 2 awards from USAID to advance HIV prevention technologies for women
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/29/2017)... PA (PRWEB) , ... May 29, 2017 , ... The ... simple question: How do doctors determine if someone is cured? The virus has a ... most expensive and time-consuming tests. , Scientists at the University of Pittsburgh’s Graduate School ...
(Date:5/28/2017)... ... ... Viewers likely know Rob Lowe from such 80s hits as St. Elmo’s Fire ... NBC’s The West Wing and Parks and Recreation. But recently, Lowe’s leant his talents ... spotlight on important modern-day issues that face today’s society. One of the most recent ...
(Date:5/27/2017)... ... May 27, 2017 , ... Most us are familiar ... a new study from the Osteoarthritis Initiative shows that certain people who ... Knowing this in advance may give doctors the opportunity to treat patients before the ...
(Date:5/26/2017)... ... May 26, 2017 , ... Amir Qureshi, MD is the first physician in ... cord stimulation system. The Nuvectra™ Algovita SCS System has been FDA approved as a ... first in Arkansas to introduce the most powerful SCS system and the only stretchable ...
(Date:5/26/2017)... ... May 26, 2017 , ... On May 24, the Congressional Budget Office (CBO) ... House on May 4, would result in 23 million Americans losing their health insurance ... 2010 Patient Protection and Affordable Care Act (ACA). , “It is clear from ...
Breaking Medicine News(10 mins):
(Date:5/22/2017)... VALLEY COTTAGE, N.Y. , May 22, 2017 ... natural antiviral treatment Gene-Eden-VIR/Novirin, announces the launch of ... in plain English, the results of a clinical ... after one year treatment with Gene-Eden-VIR/Novirin in individuals ... is important to note that there are no ...
(Date:5/18/2017)... -- Bayer announced today that the latest research from across ... 53 rd Annual Meeting of the American Society ... Chicago . The ... and thyroid cancers, as well as lymphomas, and includes ... of copanlisib in patients with relapsed or refractory follicular ...
(Date:5/12/2017)... Canada joint tech company Laughing Face has developed ... and features a powerful disinfection process. The company has ... and sanitizes women,s panties or babies, cloth diapers in 25 minutes. ... Laughing ... external water inlet. ...
Breaking Medicine Technology: