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Management of Anemia in Chronic Kidney Disease

Management of Anemia in Chronic Kidney Disease. Dr. Overview. CKD Anemia Anemia of CKD Consultant pharmacist challenges with MRR for dialysis patients Managing and treating patients on dialysis Cases for review. Chronic Kidney Disease (CKD) in the U.S.

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Management of Anemia in Chronic Kidney Disease

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  1. Management of Anemia in Chronic Kidney Disease Dr.

  2. Overview • CKD • Anemia • Anemia of CKD • Consultant pharmacist challenges with MRR for dialysis patients • Managing and treating patients on dialysis • Cases for review

  3. Chronic Kidney Disease (CKD)in the U.S. • National Kidney Foundation (NKF) classification system 2002 for staging CKD • CKD previously called: • Chronic renal failure • Pre-ESRD • Renal failure • Renal damage • Kidney disease

  4. KDOQI Defines CKD

  5. Stages of Chronic Kidney Disease NKF Kidney Disease Outcomes Quality Initiative (K/DOQI): CKD Stages1 Reference:1. National Kidney Foundation. Am J Kidney Dis. 2002;39(suppl 1):S1-S266.

  6. CKD Continuum Renal Insufficiency ESRD 1 Kidney Damage with normal or  GFR 2 Kidney Damage with Mild GFR  5 KidneyFailure 3 Moderate GFR  4 Severe GFR  90 80 70 60 50 40 30 20 <15 or Dialysis/ Transplantation (RRT) GFR (mL/min/1.73 m2) NKF-KDOQI Stages of CKD NKF-K/DOQI. Am J Kidney Dis. 2002;37:S1-S266.

  7. Markers of Renal Function • Serum creatinine • Cockcroft-Gault Equation • eCrCl • MDRD Equation • eGFR

  8. Calculating Creatinine Clearance Cockcroft-Gault Equation CrCl men = (140 - Age) x LBW Scr x 72 CrCl women = CrCl men x 0.85 Modification of Diet in Renal Disease Equation (MDRD) CrCl men = (Scr) -1.154 x (age) -0.203 CrCl women = CrCl men x 0.742 CrCl African American = CrCl men x 1.210 http://www.mdrd.com/

  9. USRDS: ESRD Incidence by Age • Patients Age 65 Years or Older Are More Than Twice as Likely to Have ESRD as People Under Age 50 Years1 Adapted from the United States Renal Data System (USRDS).1 Reference: 1. United States Renal Data System. 2007 annual data report reference tables: incidence. Available at: http://www.usrds.org/2007/ref/A_incidence_07.pdf. 9

  10. In LTC Residents, the Prevalence of CKD Increases With Age 40% of the population had a GFR of <60 mL/min/1.73 m2 (MDRD) n=106 n=671 n=3354 n=977 n=1061 n=2644 Age-Related Prevalenceof Low GFR (%) n=646 n=472 Age in Years n=9931 MDRD=Modification of Diet in Renal Disease. Reference: Garg et al. Kidney Int. 2004;65:649-653.

  11. Almost One Half of All LTC Residents Have GFR <60 mL/min/1.73 m2 Residents with CKD (GFR <60 mL/min/1.73 m2)44% Residents without CKD56% N=4240 (residents with SCr, calculating GFR using MDRD) SCr=serum creatinine. Reference: Van Vleet et al. Poster presented at: American Geriatric Society Annual Meeting; May 11-15, 2005; Orlando, Fla.

  12. CKD Risk Factors

  13. Contributors to Renal Function Decline • Decline in kidney weight, loss of nephrons • Decline in renal perfusion • Decline in GFR • Est healthly adults lose 8-10ml/min of GFR every decade of life beginning around age 30 • Decrease in ability to concentrate urine • Decreased reabsorption of sodium • Decreased bladder capacity Beck LH. Long-term Care Forum. 5(3) 1995.

  14. Risk Factors for ESRD25 Year Follow-up • Retrospective review of 177,570 individuals from large MCO (1964-’73) • Followed for ESRD Tx (USRDS) • 842 cases ESRD observed • Goal: evaluate value of potential novel risk factors for ESRD vs established risk factors Chi-yuan Hsu, MD, MSc; Carlos Iribarren, MD, PhD, et al.Arch Intern Med. 2009; 169(4):342-350

  15. Risk Factors for ESRD25 Year Follow-up cont’d Established Risk Factors for ESRD: Gender (M) Age Proteinuria* DM HTN AA race Elevated SCr (or, decreased GFR) Obesity* Lower educational attainment *most potent risk factors Chi-yuan Hsu, MD, MSc; Carlos Iribarren, MD, PhD, et al.Arch Intern Med. 2009; 169(4):342-350

  16. Risk Factors for ESRD25 Year Follow-up cont’d • Independent Risk Factors for ESRD: • Lower Hgb • Higher serum uric acid level (in females) • Self-reported Hx of nocturia • Family Hx of kidney disease Chi-yuan Hsu, MD, MSc; Carlos Iribarren, MD, PhD, et al.Arch Intern Med. 2009; 169(4):342-350

  17. Complications of CKD • CVD • “All patients with chronic kidney disease should be considered in the ‘‘highest risk’’ group for cardiovascular disease, irrespective of levels of traditional CVD risk factors.” • HTN (cause and complication) • Protein energy malnutrition • Central and peripheral neuropathy • Anemia • ESRD • Bone disease/disorders of calcium and phosphorus National Kidney Foundation. K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification and Stratification. Am J Kidney Dis 39:S1-S266, 2002 (suppl 1)

  18. Anemia

  19. Defining Anemia (NKF) • Group of diseases characterized by a decrease in either Hgb, Hct or red blood cells (RBC) that reduce the oxygen carrying capacity of the blood. Diagnose anemia if: - Hemoglobin < 12 g/dL (adult females) - Hemoglobin < 13.5 g/dL (adult males) • In patients with CKD the hemoglobin should be 11 g/dL or greater KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease. Am J Kidney Dis 47:S1-S146, 2006 (suppl 3)

  20. World Health Organization • WHO definition of anemia: • Males Hgb< 13 gm/dL • Females Hgb < 12 gm/dL World Health Organization: Nutritional anemia: report of a WHO Scientific Group. Geneva, Switzerland: World Health Organization, 1968.

  21. Common Causes of Anemia in Elderly Patients Joosten E, et al, Prevalence and causes of anemia in a geriatric hospitalized population. Gerontology 1992; 38:111-117

  22. Cause of Anemia in Long Term Care Chronicdisease Chronickidney disease Unknown Fe, B12, folate Other n=481 LTC=long-term care. Reference: Chernetsky et al. Harefuah. 2002;141:591-594.

  23. Signs and Symptoms of Anemia Are Nonspecific • Central nervous system (CNS) • Fatigue • Headache • Dizziness • Syncope • Depression • Impaired cognition • Cardiorespiratory system • Dyspnea • Tachycardia • Systolic ejection murmur • Palpitations • Cardiac enlargement • Hypertrophy • Wide pulse pressure • Hypotension • Orthostasis • Vascular system • Cold intolerance • Edema • Pallor of skin, mucous membranes, and conjunctivae • Gastrointestinal system • Anorexia • Nausea • Genital tract • Impotence Reference: Morley et al. Ann Long-Term Care. 2003:S1-S21. Available at: http://www.annalsoflongtermcare.com/supplements.cfm. Accessed February 6, 2007.

  24. Laboratory Tests for Anemia Reticulocyte count (low indicates decreased RBC production; high count may be increased RBC destruction) Sedimentation rate (ESR): index of inflammation Stool for occult blood: evaluates GI loss Morphology by peripheral smear: size, color, shape of RBC Hepatic and renal function Thyroid-stimulating hormone (TSH)

  25. Medications That Can Cause Anemia Reference: American Medical Directors Association. Clinical Practice Guideline. Columbia, MD: American Medical Directors Association; 2007.

  26. Treating Anemia • B-12 Deficiency • B-12 replacement • Oral, sublingual, intranasal, IM • Folic Acid Deficiency • Folic acid replacement • Oral, subcutaneous, IM • Iron Deficiency • Iron replacement (several salt forms/dose forms) Oral, IV, IM • Anemia of Chronic Kidney Disease (CKD) • Erythropoietic Stimulating Agents • Epoetin Alfa (Epogen™/Procrit™), Darbepoetin Alfa (Aranesp™) KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease. Am J Kidney Dis 47:S1-S146, 2006 (suppl 3)

  27. Assessing Anemia • JM 84 yo female • Dx: anemia, DM, dementia, incontinence, osteoarthritis, osteoporosis • Recurrent falls • CNAs report “she won’t use the call light” • What action, in general, should the CP take when requested to review resident for falls for an interim MRR?

  28. Iron Products and Drug Interactions • Avoid administration with calcium, antacids, levothyroxine, levodopa, fluoroquinolones, PPIs, H-2 blockers

  29. Iron and the State Operations Manual (SOM) • Iron does not stimulate rbc production • Iron does not correct anemia that is not caused by iron deficiency • Document chronic use • Document doses > once daily • Documentation for “clinical rationale” may include use of an ESA

  30. When is “Enough” Iron “Too Much”? • F329 Unnecessary Drugs Table 1 • “Iron therapy is not indicated in anemia of chronic disease when iron stores and transferrin levels are normal or elevated” • “Clinical rationale should be documented for long-term use (> 2 months) or > 1 daily > 1 week because of side effects and risk of iron accumulation in tissues”

  31. Adverse Outcomes Associated With Anemia in Older Adults Decreased muscle strength and physical function1 Increased heart disease2 Increased risk of stroke10 Anemia Increased frequency of hospital admission7,8 and death7-9 Increased falls3 and fall-related injuries4 Cognitive impairment5,6 References: 1. Penninx et al. J Am Geriatr Soc. 2004;52:719-724. 2. Zeidman et al. Isr Med Assoc J. 2004;6:16-18. 3. Guse et al. WMJ. 2003;102:37-42. 4. Herndon et al. J Am Geriatr Soc. 1997;45:739-743. 5. Zuccala et al. Am J Med. 2005;118:496-502. 6. Arygyriadou et al. BMC Fam Pract. 2001;2:5. 7. Felker et al. J Cardiol. 2003;92:625-628. 8. Li et al. Kidney Int. 2004;65:1864-1869. 9. van Dijk et al. J Am Geriatr Soc. 2005;53:660-665. 10. Abramson et al. Kidney Int. 2003;64:610-615.

  32. Impact of Anemia on QIs • Incidence of new fractures • Prevalence of falls • Prevalence of behavioral symptoms • Prevalence of symptoms of depression • Incidence of cognitive impairment • Prevalence of weight loss • Prevalence of dehydration • Incidence of decline in ADLs • Prevalence of little or no activity • Prevalence of psychoactive medication use

  33. Anemia of CKD

  34. Anemia Worsens as Kidney Function Declines Hb Levels Hb=11-12g/dL (n=181) Hb=10-11 g/dL (n=105) Hb=<10 g/dL (n=315) Reference: Adapted from Kausz et al. Dis Manage Health Outcomes. 2002;10:505-513.

  35. Etiology of CKD Anemia • Decreased rbc production due to lack of erythropoietin; kidneys responsible for 90% of epo production • Increased rbc destruction due to hemolysis • Increased blood loss due to multiple venipunctures • Decreased rbc production is present in CKD anemia and anemia of chronic disease, and both are normochromic, normocytic anemias Anemia of Chronic Disease and Renal Failure. http://emedicine.medscape.com Accessed Sept 12, 2009

  36. Renal Anaemia • damaged kidney • impaired production of erythropoietin • reduced number of red blood cells • anaemia

  37. Erythropoietin Deficiency X Iron Erythropoietin Erythroid marrow RE cells Red blood cells O2 delivery RE=reticuloendothelial Adapted from: Fauci AS, et al, eds. Harrison’s Principles of Internal Medicine. 1998; 334.

  38. Factors That Cause or Contribute to Anemia in CKD Erythropoietin deficiency (insufficient production of endogenous erythropoietin) Iron deficiency Acute/chronic inflammatory conditions Severe hyperparathyroidism Aluminum toxicity Folate deficiency Decreased RBC survival Hemoglobinopathies (eg, alpha-thalassemia, sickle-cell anemia) α KDOQI. Am J Kidney Dis. 2001;37(1 Suppl 1):S182-238. Agarwal AK. J Am Med Dir Assoc. 2006;7(9 Suppl):S7-S12.

  39. increase exercise capacity improve cognitive function regulate and/or prevent left ventricular hypertrophy prevent progression of renal disease reduce risk of hospitalisation decrease mortality Key goals in managing anaemia of CKD

  40. What the recommendations cover Diagnosis of anaemia of CKD Management of anaemia of CKD Assessment and optimisation of erythropoiesis Maintaining stable haemoglobin Monitoring of ACKD treatment

  41. Assessment of Anemia in CKD Test Hb at least annually in all patients, regardless of stage or cause of CKD Hct is a derived value, affected by plasma water, and, therefore, can be imprecise as a direct assessment of erythropoiesis. In contrast to Hct, Hb values are absolute and directly impacted by decreased erythropoietin production by the kidney1 Assessment should include the following tests: A complete blood count Absolute reticulocyte count Serum ferritin to assess iron stores Serum transferrin saturation (TSAT) or content of Hb in reticulocytes to assess adequacy of iron for erythropoiesis Stool for occult blood2 References: 1. National Kidney Foundation. Am J Kidney Dis. 2006;47(suppl 3):S1-S145. 2. National Kidney Foundation. Available at: http://www.kidney.org/professionals/kdoqi/guidelines_updates/doqiupan_i.html.

  42. Treatment for Anemia of CKD Replete iron stores to maintain: TSAT > 20% and Serum ferritin >100ng/ml Consider erythropoiesis-stimulating agent (ESA) Continue to evaluate responsiveness to treatment When treating with ESA, avoid Hgb > 12 gm/dL

  43. Anemia of CKD Management Supplement iron; most patients should receive oral iron supplement to prevent the development of iron deficiency even if iron studies are normal at initiation of therapy* Select ESA therapy Epoetin alfa Darbepoetin alfa Monitor Hgb, adjust dose by 25% no more frequently than monthly to reach and maintain target *Wish JB, Coyne DW. May Clin Proc.2007;82:1371-80.

  44. Hgb Target and ESAs Consider risk to benefit Hgb targets 11-12 g/dL per 2007 NKF KDOQI guidelines 10-12 g/dL per FDA package inserts Do not exceed Hgb >12 g/dL; adjust dose as “Hgb approaches 12 gm/dL” Monitor Hgb: Weekly: darbepoetin Twice weekly: epoetin

  45. Black Box Warning Renal Failure: Patients experienced greater risk for death and serious cardiovascular events when administered ESAs to a target higher versus lower hemoglobin level in two clinical studies. Individualize dosing to achieve and maintain a target hemoglobin within the range of 10 to 12 g/dL. Nov 07 Aranesp [package insert]. November 2007. Epogen [package insert]. November 2007. Procrit [package insert]. November 2007

  46. Diagnosis of anaemia of CKD in adults eGFR < 60ml/min/1.73m2 AND Hb ≤ 11 g/dl Treat and repeat Hb Yes No Non renal and haematinic deficiency excluded? No Consider other causes Yes No See initial management algorithm Patient on haemodialysis? See sections 1.2 & 1.3 Yes

  47. Initial management algorithm Ferritin < 500 µg/l? Yes No Ferritin < 200 µg/l? TSAT < 20% Or %HRC > 6% No Yes ESA (s.c.or i.v.) Yes – functional iron deficiency No Assess Hb If Hb increase < 1g/dl after 4 weeks, increase ESA using dose schedule ESA (s.c.or i.v.) and iron Hb > 9 g/dl Hb < 9 g/dl Continue monitoring Hb and iron status Hb < 11 g/dl i.v. iron Assess Hb at 6 weeks Hb > 11 g/dl

  48. Assess and optimise erythropoiesis • Iron supplements should be given to maintain serum ferritin levels • ESA therapy is appropriate in iron-replete patients where existing comorbidities or prognosis do not negate its effect • Benefits of ESA therapy include improved quality of life and physical functioning • There is no evidence to distinguish between ESAs in terms of efficacy

  49. Hb maintenance algorithm (assumes ESA therapy and maintenance i.v. iron) Measure Hb Hb < 11 g/dl Hb 11–12 g/dl Hb 12–15 g/dl Hb > 15 g/dl ↑ ESA dose/ frequency as per schedule unless Hb rising by 1/g/dl/month. Check Hb as per Schedule. No change unless Hb rising by 1g/dl/month in which case consider ESA dose adjustment Consider stopping i.v. iron. ↓ ESA dose/frequency as per schedule unless Hb falling by more than 1g/dl/month. Check Hb as per schedule. Stop i.v. iron. Consider stopping ESA or halve dose/frequency. Check Hb in 2 weeks. If Hb is persistently low see poor response algorithm Ferritin < 200 µg/l?

  50. Iron dosage schedule

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