Opportunity ID: 254083
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-020 |
| Funding Opportunity Title: | Prospective Studies 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: | $4,000,000 |
| Award Ceiling: | $1,000,000 |
| Award Floor: | $750,000 |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses County governments Native American tribal governments (Federally recognized) Special district governments Public and State controlled institutions of higher education Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Private institutions of higher education City or township governments Small businesses Native American tribal organizations (other than Federally recognized tribal 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 clinical safety and efficacy 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 in well controlled clinical studies. 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 prospective, open-label, randomized, multicenter, parallel, 3-year (or longer) observational study in kidney, heart, liver transplant recipients using any model drug or drug combination listed above. 2. Assess the safety and efficacy profiles in 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. Patient and graft survival, severity of biopsy-proven acute rejection and other efficacy points will be monitored. Methods such as properly scheduled visits at the transplantation centre, phone monitoring, and patients self-monitoring should be employed. Safety can be assessed based on treatment-emergent adverse events, the results of routine clinical laboratory tests, and vital sign measurements at time intervals relevant for particular transplantation type and type of medicinal product under evaluation. 3. Evaluate patient adherence to the immunosuppressive regimen, as well as the frequency and extent of dosage adjustment 4. If therapeutic drug monitoring is routinely used, drug concentration data should be collected and evaluated. |
| 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-14-020 | PKG00195496 | Apr 18, 2014 | Jun 23, 2014 | View |
Package 1
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