Opportunity ID: 254080
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-021 |
| Funding Opportunity Title: | Retrospective Analysis on the Impact of Generic Immunosuppressants on Acute Rejection and Long Term Graft Survivals (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 18, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jun 21, 2014 |
| Current Closing Date for Applications: | Jun 21, 2014 |
| Archive Date: | Jul 21, 2014 |
| Estimated Total Program Funding: | $2,000,000 |
| Award Ceiling: | $1,000,000 |
| Award Floor: | $750,000 |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities State governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public and State controlled institutions of higher education Independent school districts Private institutions of higher education Small businesses City or township governments |
| Additional Information on Eligibility: | Foreign Recipients |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | 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 communitys 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: Detailed Descriptions: 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. |
| Link to Additional Information: | Copy of published RFA |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys Melendez-Bohler
Grants Management Officer/Specialist Phone 240-402-7565 Email:gladys.bohler@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Packages
| Agency Contact Information: | Gladys Melendez-Bohler Grants Management Officer/Specialist Phone 240-402-7565 Email: gladys.bohler@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | ADOBE-FORMS-C | RFA-FD-14-021 | PKG00195493 | Apr 18, 2014 | Jun 23, 2014 | View |
Package 1
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