National Kidney Foundation Announces Major Expansion of DOQI Guidelines

New York, NY (January 24, 2000) - Building on the success of the National Kidney Foundation-Dialysis Outcomes Quality Initiative (NKF-DOQI), which developed clinical practice guidelines in five areas of dialysis care, the foundation is expanding the scope of study to include all phases of kidney disease and dysfunction and their monitoring and management. The new initiative will be called Kidney Disease Outcomes Quality Initiative, or K/DOQI, the foundation announced today.

The centerpiece of K/DOQI will be a set of clinical practice guidelines on Chronic Kidney Disease: Evaluation, Classification and Stratification, to be developed by year end under the leadership of Workgroup Chair Andrew Levey, MD. According to Nathan Levin, MD, co-chair of K/DOQI, "Millions of Americans are in various stages of renal insufficiency, and until now there has been no definitive categorization of the various clinical indicators of progressing renal disease. This milestone effort," he continues, "will standardize the terminology, assessment and understanding of kidney disease from initial injury to end stage. It will also specify appropriate monitoring techniques, recommend their frequency based on individual profiles, risk stratification and co-morbid conditions, and provide a basis for interventional studies."

"As director of the Nephrology Program and its Clinical Research Center at the New England Medical Center in Boston and a leading authority in the field, Dr. Levey is extremely well-qualified to lead the workgroup charged with developing these guidelines," says Garabed Eknoyan, MD, K/DOQI co-chair.

The K/DOQI effort will also encompass publication of the final NKF-DOQI guideline on nutrition and updates to the original guidelines on hemodialysis, anemia management, vascular access and peritoneal dialysis. These updates are based on evidence published since 1997 and reflect the foundation's commitment to maintaining the guidelines as a living document.

K/DOQI will eventually include the development of guidelines on bone disease and cardiovascular disease in patients with chronic kidney disease and transplant recipients.

Leading and providing on-going guidance to the K/DOQI program will be a 37-member Advisory Board. All have been chosen for their individual expertise in the areas impacted by the K/DOQI guidelines. Guideline development for K/DOQI will follow the same rigorous scientific methodology that was established for DOQI.

According to Dr. Eknoyan, "The goal of our new initiative is to create classifications of kidney disease from the earliest beginning through the entire spectrum of its progression. We are developing guidelines for intervention and treatment at all stages, not just when patients have reached overt kidney failure. We anticipate that this landmark effort will help prevent the kidney dysfunction in many cases and slow the progression of the disease in others."

K/DOQI will stratify patients with kidney disease based on the severity of their renal impairment and risk factors for progression of their disease, such as ethnicity, proteinuria, obesity, age, lipid levels and bone disease, as well as co-morbidities such as diabetes, hypertension and cardiovascular dysfunction. Specific evaluation and treatment guidelines will be developed for subsets of individuals with different risk factors.

Amgen, which was Founding and Principal Sponsor of NKF/DOQI, will continue in that role with K/DOQI through an unrestricted educational grant. Dr. Eknoyan stated, "We are grateful to Amgen for supporting this new expansion of the DOQI. Our experience has convinced us that practice guidelines developed using the core DOQI principles of rigor, interdisciplinary approach, workgroup independence and openness can significantly improve the clinical outcomes of kidney patients."

Unrestricted support has also been received from Abbott Renal Care and Genzyme. Additional corporate support is expected.