• July 31, 2008, Erythropoiesis Stimulating Agents (ESAs): Amgen and the U.S. Food and Drug Administration (FDA) informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated.
• November 8, 2007 and January 3, 2008 Update, Erythropoiesis Stimulating Agents (ESAs): The U.S. Food and Drug Administration (FDA) notified healthcare professionals of revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs) stating serious adverse events, such as tumor growth and shortened survival in patients with advanced cancer and chronic kidney failure.

¹If not calculated by lab, refer to the National Kidney Foundation website for GFR calculator (http://www.kidney.org/professionals/tools/)

Risk Factor Management and Patient Education

All Adults at Increased Risk for CKD

• Evaluation and management of comorbid conditions (e.g. diabetes, hypertension, urinary tract obstruction, cardiovascular disease)²
• Review medications for dose adjustment, drug interactions, adverse effects, therapeutic levels
• Educate on therapeutic lifestyle changes: dietary sodium intake < 2.4 grams/day (g/d) recommended for patients with CKD and hypertension [A], weight maintenance if body mass index (BMI) <25, weight loss if BMI ≥ 25, exercise and physical activity, moderation of alcohol intake, smoking cessation

Frequency. At each routine health exam

²Reference MQIC guidelines on diabetes, hypertension, hyperlipidemia and obesity (http://www.mqic.org).

Adults with CKD

All of the above plus:

• Develop clinical action plan for each patient, based on disease stage as defined by the National Kidney Foundation, Kidney Disease Outcomes Quality Initiative (K/DOQI) [B]
• Incorporate self-management behaviors into treatment plan at all stages of CKD [B]

Frequency. At each routine health exam

Core Principles of Treatment

Adults with CKD

• Stage 1 (GFR >90): Monitor GFR annually, smoking cessation, consider aspirin (ASA), consider angiotensin converting enzyme (ACE) and/or angiotensin receptor blocker (ARB) therapy, blood pressure (BP) goal <130/80, low density lipoprotein-cholesterol (LDL-C) goal <100
• Stage 2 (GFR 60–89): Nephrology referral if GFR decline > 4ml/min/yr, maintain BP and lipid goals as above
• Stage 3 (GFR 30–59): Consult Nephrologist and Renal Dietician; Suppress parathyroid hormone (PTH) with vitamin D to level appropriate for CKD stage; Phosphorus lowering treatment if > 4.6 mg/dl; Correct iron deficiency before start of epoetin therapy; Epoetin if hemoglobin (Hgb) (hematocrit [Hct]) <11 (33%); renal-specific vitamins; Update vaccines: hepatitis B virus (HBV), influenza, diphtheria/tetanus acellular pertussis vaccine (Tdap) and Pneumovax
• Stage 4 (GFR 15–29): Nephrology and vascular access surgery referrals, Epoetin if Hct <33%, Optimize Ca x P product to < 55 with specific agents, update vaccines as indicated, CKD education classes
• Stage 5 (GFR <15): Renal replacement therapy

Frequency. As indicated

Definitions:

Levels of Evidence for the Most Significant Recommendation

1. Randomized controlled trials
2. Controlled trials, no randomization
3. Observational studies
4. Opinion of expert panel

This guideline is based on several sources, including: the 2002 National Kidney Foundation/Kidney Disease Outcomes Quality Initiative Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification and Stratification (www.kidney.org).

This guideline is based on the 2002 National Kidney Foundation/Kidney Disease Outcomes Quality Initiative Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification and Stratification (www.kidney.org).

Electronic copies: Available in Portable Document Format (PDF) from the Michigan Quality Improvement Consortium Web site.

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