Renal Research FAQs

Overview Information

What are clinical trials? How do they work?

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)

What’s the difference between late-phase and early-phase clinical trials?

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.

Do renal research trials differ from clinical trials?

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.

Where do our trials take place?

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. 

How is DaVita Clinical Research (DCR) related to DaVita?

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

Is DaVita Clinical Research an SMO or CRO?

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

What is a Site Management Organization (SMO)?

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. 

Will DCR help with IRB planning & feasibility assessments?

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. 

Who does DCR typically work with?

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

How do I schedule a trial?

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. 

How can I access DaVita’s patient database?

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. 

Does DCR help with enrollment and facility management?

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. 

What research projects are available to my sites?

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

What are clinical trials? How do they work?

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)

What’s the difference between late-phase and early-phase clinical trials?

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.

Do renal research trials differ from clinical trials?

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.

Where do our trials take place?

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. 

How is DaVita Clinical Research (DCR) related to DaVita?

DCR is the research arm of DaVita Inc. All projects considered “research” in nature within DaVita Inc. are typically approved through DaVita Clinical Research.