Renal Research FAQs
Overview Information
Clinical trials are used for determining the safety and efficacy of new medications and devices for use in the general patient population. For more information as to exactly how they work please visit this link (https://clinicaltrials.gov/ct2/about-studies/learn).
Early phase trials are focused on the safety and tolerability of a medication/device, while trials in late phase focus on the efficacy of a medication/device or how well they work.
Renal research works very much the same as all FDA (Food & Drug Administration) approved trials. However, for renal research, most of the study procedures take place in a dialysis facility.
Most of our trials take place in the same location as where patients receive their dialysis treatments. In pre-dialysis clinical trials, research visits take place in the physician practice or a dedicated research office.
DCR is the research arm of DaVita Inc. All projects considered “research” in nature within DaVita Inc. are typically approved through DaVita Clinical Research.
Pharma and Biotech Information
DaVita functions more as an SMO than a CRO. We manage the integration of sites and their research projects into the dialysis facilities. We do not provide any CRO services aside from protocol consultation services.
An SMO can mean a variety of things. Our main function is the integration of research protocols into the dialysis facilities. We also provide SMO services such as regulatory preparation for site submissions, contracting for the site network and managing payments to the sites directly.
Yes. This is one of our main functions and we can assist with the distribution and collection of feasibility documents as well as the collection and review of IRB documents for site submissions.
DCR has worked with every major CRO and pharma company in the renal business. We also have a long history of working with and advising smaller pharma (biotech) in the implementation of their trials.
Physician Initiated Research Information
If you are a physician or research site with a potential trial, you can email researchrequests@davita.com with initial information and we can work with you from there.
DaVita supports healthcare analytic research projects and may be able to provide some data for your research project that falls within our data privacy policies. Contact researchrequests@davita.com for more information.
The scope of the research project and the type of site selected will determine the amount of support DCR can provide. DCR oversees two types of site models, Affiliate and Alliance. Under the Affiliate model, DCR will assist training and the implementation of research in the DaVita dialysis center. The alliance model is more involved, DCR employs Study Coordinators to help with enrollment and overall study management.
Access studies (catheter), Oral anemia meds, IV anemia, Catheter itch, phosphate binding, phosphate target guidelines, Pruritus (itch), treating inflammation in CKD, Diabetic kidney disease, Hyperuricemia in CKD, Focal and Segmental Glomerulosclerosis (FSGS), etc.
Patient Information
Clinical trials are used for determining the safety and efficacy of new medications and devices for use in the general patient population. For more information as to exactly how they work please visit this link (https://clinicaltrials.gov/ct2/about-studies/learn).
Early phase trials are focused on the safety and tolerability of a medication/device, while trials in late phase focus on the efficacy of a medication/device or how well they work.
Renal research works very much the same as all FDA (Food & Drug Administration) approved trials. However, for renal research, most of the study procedures take place in a dialysis facility.
Most of our trials take place in the same location as where patients receive their dialysis treatments. In pre-dialysis clinical trials, research visits take place in the physician practice or a dedicated research office.
DCR is the research arm of DaVita Inc. All projects considered “research” in nature within DaVita Inc. are typically approved through DaVita Clinical Research.