Precision Medicine for Type 1 Diabetic Nephropathy (U01 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), specifically the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), has announced a new funding opportunity for research sites focused on Precision Medicine for Type 1 Diabetic Nephropathy. This program aims to recruit both adult and pediatric patients with Type 1 diabetes (T1D) who have or are at high risk of developing diabetic nephropathy. The selected research sites will engage in a longitudinal cohort study and conduct protocol-based research kidney biopsies, collaborating with the Kidney Precision Medicine Project (KPMP). The key goal of the initiative is to expand the KPMP’s efforts by creating a Kidney Tissue Atlas, identifying disease subgroups, and discovering novel therapeutic targets. The purpose of this funding opportunity is to establish new recruitment sites (RS) within the existing KPMP framework. These RS will focus on patients with T1D, with an emphasis on kidney biopsies, longitudinal clinical phenotyping, and the collection of biological and demographic data. The study will also integrate social determinants of health to deepen the understanding of the disease. By collecting these samples, the project aims to identify the underlying molecular pathways that drive diabetic nephropathy, allowing for the development of targeted treatments and precision medicine approaches. Funding for this initiative is expected to be $1.3 million, supporting 2 to 3 sites with annual budgets of up to $400,000 in direct costs. Each site will be expected to recruit around 15 to 20 patients annually and carry out high-quality kidney biopsies while ensuring participant safety and adhering to rigorous ethical standards. Research sites are required to have experience in nephrology, endocrinology, and kidney biopsies, and must show a strong ability to collaborate within the KPMP network, which includes adhering to common protocols and contributing to the KPMP-wide data-sharing and tissue-interrogation efforts. Eligible applicants include higher education institutions, public and private nonprofits, and for-profit organizations, among others. Applications are due by December 10, 2024, and must comply with all submission instructions outlined in the NIH Application Guide and the KPMP protocol requirements. Sites currently participating in the KPMP are not eligible to apply. A multidisciplinary approach is encouraged, involving nephrologists, endocrinologists, radiologists, and ethicists, along with researchers experienced in working with diverse communities and social determinants of health. Institutions must demonstrate capacity for patient recruitment and safe biopsy practices, as well as a commitment to long-term follow-up and data integration. In terms of evaluation, applications will be reviewed for their significance, innovation, approach, investigator qualifications, and the overall environment of the institution. The selection process will prioritize the sites’ ability to recruit and retain diverse participants, ensure participant safety during kidney biopsies, and contribute to the broader scientific goals of the KPMP. The initial review of applications will take place in March 2025, with final decisions expected by May 2025 and project initiation slated for July 2025. All applicants are required to comply with the NIH’s data-sharing and ethical standards, including obtaining consent for genetic studies and longitudinal follow-up. The awarded sites will be expected to collaborate closely with the KPMP Central Hub and other KPMP components, ensuring that all data and biological samples are handled according to the highest standards of quality control and FAIR data principles (Findable, Accessible, Interoperable, and Reusable).