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

Quick Facts

Due DateJune 21, 2014 (Saturday)
Award Amount$ 750,000 - $ 1,000,000
Category of Funding ActivityHealth
Science and Technology and other Research and Development
Eligible Applicants
  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Native American tribal governments (Federally recognized)
  • Public housing authorities/Indian housing authorities
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Private institutions of higher education
  • For-profit organizations other than small businesses
  • Small businesses
  • Others - Foreign Recipients

Program 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 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.

General Information

Funding Opportunity NumberRFA-FD-14-021
Funding Opportunity TitleRetrospective Analysis on the Impact of Generic Immunosuppressants on Acute Rejection and Long Term Graft Survivals (U01)
Opportunity CategoryHealth
Science and Technology and other Research and Development
Funding Instrument TypeCooperative Agreement
Category ExplanationNot Available
Number of Awards1
Cost Sharing or Matching RequirementNo
Posted DateApril 18, 2014 (Friday)
Application Due DateJune 21, 2014 (Saturday)
Application Archive DateJuly 21, 2014 (Monday)
Total Program Funding$ 2,000,000
Award Amount$ 750,000 - $ 1,000,000
CFDA Number
  • 93.103 - Food and Drug Administration_Research

Eligible Applicants

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Native American tribal governments (Federally recognized)
  • Public housing authorities/Indian housing authorities
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Private institutions of higher education
  • For-profit organizations other than small businesses
  • Small businesses
  • Others - Foreign Recipients

Contact Information

Agency NameDepartment of Health and Human Services
Program Information WebsiteCopy of published RFA
ContactOffice: Food & Drug Administration
Gladys Melendez-Bohler
Grants Management Officer/Specialist
Phone 240-402-7565
FDA Office

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