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special feature Kansas Nephrology Research institute K ANSAS NEpHRoLogy RESEARCH Institute (KNRI) performs clinical trials for new treatments of kidney disease, diabetes, metabolic bone disease and hyperlipidemia. KNRI is part of a unique, integrated research network (Research Management Inc.) that specializes in Phase II–IV clinical research studies, predominantly in nephrology. Phase II clinical trials usually involve a relatively small number of patients (100–300) among whom safety of the drugs is the primary concern. If the Phase II trials indicate the drug or treatment may be effective and the risks are acceptable, the drug or treatment moves to Phase III. Phase III trials involve a larger population of affected individuals and continue to evaluate safety but also seek to confirm the effectiveness of the treatment. Typically, 1,000–3,000 patients are enrolled. The U.S. Food and Drug Administration (FDA) helps the pharmaceutical company design these trials, so if they are successful, the drug can move to ultimate approval. Phase IV trials take place after drug approval to further evaluate the long-term risk of the drug and to test the drug and/ or treatment in different populations. Before patients are enrolled in a clinical trial, they are evaluated to see if they meet the enrollment criteria. The informed consent is reviewed with the patients, and the known risks are discussed. Any adverse outcome is reported to the company. When the adverse outcome is severe, it is reported to the FDA and the Institutional Review Board (IRB), the entity that has to approve the informed consent and the protocol. The IRB assures that the welfare and rights of the research subjects are protected. Why would a patient participate in a clinical trial? For some, it offers new treatments not yet available for their conditions. Others want to help advance medical knowledge. Still others, who have trouble affording medical care, desire the close follow-up and free lab testing for their conditions. KNRI takes clinical trials to completion with high-quality management and well-trained personnel. Without clinical research, new treatments for the management of chronic kidney disease would not be possible. Our patients benefit from these trials by receiving cutting-edge treatments before they're available to the general public. In addition, they receive close follow-up, with frequent lab tests and physical examinations. They are compensated for their participation, and they sometimes receive travel reimbursements. Dennis Ross, M.D., founded Research Management and KNRI in 2007. He has completed his certification as a principal investigator, and our coordinators are also certified. Paula Pond, APRN, is a cer tif ied coordinator a s well a s the clinical manager of the research sit e. A d d it ion a l re s e a rc h sit e s have been established in Lincoln, NE; Austin, TX; and Wilmington, NC. At each site, a principal investigator and coordinators who assist the investigator conduct many of the same trials. By forming this clinical research network, pharmaceutical companies access multiple nephrology practices, promoting greater participation in the studies. Many of the studies are conducted with Fresenius Medical Care North America, the largest dialysis provider in the world. Currently, KNRI is enrolling patients for studies in: + Heart disease and gout + Heart disease and hyperlipidemia or stroke + Anemia of chronic kidney disease (CKD) + Vitamin D deficiency and CKD + Secondary hyperparathyroidism in end-stage renal disease patients + New treatments for diabetic glucose management in CKD patients + Monoclonal antibody treatment for diabetic nephropathy + Device study for nocturnal dialysis. KNRI promotes research within the community by assisting physicians who are approached by pharmaceutical companies and wish to participate in the studies. We have the necessary infrastructure to carry out these trials with qualified coordinators. Clinical research may not guarantee that the treatment will be effective, but it may offer patients treatments where none exist or where others have been ineffective. For more information, contact Paula Pond at (316) 262-2045 or Dennis Ross, M.D., at (316) 263-7285. You can also visit our website at www.researchmgmt.com. ■ mDNEWS.Com ■ MD News Greater Kansas |5