Retrospective Analysis on the Impact of Generic Immunosuppressants on Acute Rejection and Long Term Graft Survivals (U01)

The summary for the Retrospective Analysis on the Impact of Generic Immunosuppressants on Acute Rejection and Long Term Graft Survivals (U01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food Drug Administration, which is the U.S. government agency offering this grant.
Retrospective Analysis on the Impact of Generic Immunosuppressants on Acute Rejection and Long Term Graft Survivals (U01): Background: Survival after solid organ transplantation has increased substantially due in part to the broad clinical use of immunosuppressants. Immunosuppressive regimens typically include a combination of a calcineurin inhibitor (tacrolimus or cyclosporine), an antiproliferative agent (mycophenolate mofetil, mycophenolate sodium, or azathioprine), and corticosteroids. Proliferation signal inhibitors, e.g., sirolimus, may also be used either in combination with a calcineurin inhibitor or antiproliferative agent, or as a replacement for one. Availability of generic versions for these immunosuppressants allows for reduced drug costs that translate to increased drug access and significant cost savings for both insurers and patients. Maintenance of the immunosuppressive balance is critical for allograft patency, minimization of adverse effects, and ultimately long-term survival of solid organ transplant recipients. The question whether the brand to generic switch or switch among multiple generic products may introduce clinically relevant changes in drug exposure and thus affect acute rejection, adverse events, and long term graft survival remains debated in transplant community. To address transplant community’s concern, FDA funded research studies to compare the pharmacokinetics (PK) of approved generic tacrolimus capsules to Prograf (brand product) in stable liver and kidney adult transplant patients with moderate and high immunological risk. However, the impact of introduction of generic immunosuppressants on long term graft survival was never systematically evaluated. These clinical outcome studies are critically needed to confirm the therapeutic equivalence of generic immunosuppressants with the brand product, thereby increasing transplant community confidence on the use of generic immunosuppressants. Objectives: The objective of this study is to conduct a retrospective analysis about the impact of generic immunosuppressants on short term acute rejection and long term patient graft survival since the introduction of generic immunosuppressants. The outcome of this study will help respond to public concerns regarding the interchangeability of generic immunosuppressants and improve review practices of generic immunosuppressants if necessary. The retrospective analysis will also aid in the design of prospective studies to investigate generic substitution for immunosuppressants. Detailed Descriptions: The model drugs to be studied should include at least cyclosporine, tacrolimus, mycophenolate mofetil, and mycophenolate sodium. The project may include the following: 1. Conduct a multi-center retrospective analysis of kidney, heart, liver transplant recipients using any model drug listed above. Data including demographic, immunosuppressive medications (drug, brand/generic, single/multiple generic), dosage level and adjustment, transplant organ function, acute rejection, renal/liver biopsy results and others should be collected from clinical databases, electronic medical records or other relevant databases. 2. Evaluate patient adherence to their immunosuppressant therapy 3. Perform acute rejection and long-term survival analysis (e.g., 1, 3, 5 or 10-year survival) of patients taking brand immunosuppresants only, generic immunosuppressants only, or both brand and generic immunosuppressants. Further subgroup analysis in children, adults, and African Americans is recommended. 4. Analyze other factors such as donor-, transplant-, and patient-related risk factors which may potentially affect long-term survival of patients.
Federal Grant Title: Retrospective Analysis on the Impact of Generic Immunosuppressants on Acute Rejection and Long Term Graft Survivals (U01)
Federal Agency Name: Food Drug Administration
Grant Categories: Health Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-14-021
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Jun 21, 2014
Original Application Deadline: Jun 21, 2014
Posted Date: Apr 18, 2014
Creation Date: Apr 18, 2014
Archive Date: Jul 21, 2014
Total Program Funding: $2,000,000
Maximum Federal Grant Award: $1,000,000
Minimum Federal Grant Award: $750,000
Expected Number of Awards: 1
Cost Sharing or Matching: No
Applicants Eligible for this Grant
Private institutions of higher education
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Special district governments
Public and State controlled institutions of higher education
For profit organizations other than small businesses
State governments
City or township governments
Native American tribal organizations (other than Federally recognized tribal governments)
Independent school districts
Small businesses
County governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Additional Information on Eligibility
Foreign Recipients
Link to Full Grant Announcement
Copy of published RFA
Grant Announcement Contact
Gladys Melendez-Bohler Grants Management Officer/Specialist Phone 240-402-7565
FDA Office

Food & Drug Administration 301-443-5869
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