Novel Interventions to Reduce Morbidity and Mortality of Hemodialysis Patients

The NIH/NIDDK is soliciting applications to initiate and implement a network of participating clinical centers and a data coordinating center to perform pilot and feasibility studies of novel therapies and procedures for end-stage renal disease (ESRD) patients undergoing chronic maintenance hemodialysis (HD). Therapies and procedures may include: anti-inflammatory therapies; device or procedural interventions; anti-depressive therapies and other psychosocial interventions; and/or combination therapies.

Studies will focus on safety; feasibility; identification of dosing, pharmacokinetic, and pharmacodynamic aspects (where appropriate); and identification and preliminary evaluation of potential outcomes. Applicants are required to propose two studies to be performed sequentially over the funding period. When applicable, clinical site investigators will enlist industry collaboration to achieve the goals of the network. Investigators will also work collaboratively to implement common study protocols developed by the Steering Committee.

The ultimate goal of this FOA is to obtain the necessary information to design and implement one or more full-scale randomized controlled clinical trials of therapies or interventions to reduce morbidity and mortality in patients undergoing maintenance hemodialysis.

This is a limited submission opportunity; the University may submit one (1) grant application under this announcement. Interested faculty must submit an abstract, CV, and budget to Dean Puzas via Catherine Muzytchuk (Catherine_muzytchuk@urmc.rochester.edu) by October 1st, using the words “Novel Interventions of Hemodialysis” in the subject line. The Deans will select a candidate by October 8th.

The complete program solicitation can be found here. The deadline for the optional Letter of Intent is October 19th. The full proposal is due November 21st. It is important to remember that ORPA must receive electronic proposals five (5) business days prior to the sponsor’s deadline, along with a completed and signed University sign-off form.

 

NIH Funding Acknowledgement ** Important ** All publications resulting from the utilization of CTSI resources are required to credit the CTSI grant by including the NIH FUNDING ACKNOWLEDGEMENT and must comply with the NIH Public Access Policy.