POSTGRADUATE SCHOOL OF MEDICINE INTRODUCTION TO CHRONIC KIDNEY DISEASE Dr Michael Schulz MDSC175: Transplantation Science for Transplant Clinicians (Online) A MEMBER OF THE RUSSELL GROUP CONTINUING PROFESSIONAL DEVELOPMENT Introduction to CKD 2 Chronic Kidney Disease (CKD) Definition CKD is defined as abnormalities of kidney structure or function, present for more than 3 months • In 2002 the US National Kidney Foundation kidney disease initiative (NKFKDOQI) introduced a 5 stage classification of CKD based on estimated Glomerulofiltration Rate (eGFR) • In 2012 this classification was revised and published in the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines • Now it includes the subdivision of CKD 3 but also included 3 ACR categories in order to stratify better according to the risk of progression Introduction to CKD Key Facts CKD describes Considerable overlap abnormal kidney between CKD, Diabetes function and/or Mellitus and structure Cardiovascular disease Common, frequently unrecognised and usually asymptomatic 3 Introduction to CKD Key Facts Advanced CKD carries an increased risk of other significant adverse outcomes Risk of CKD increases with such acute kidney injury, increasing age more severe co-morbidities and increased mortality 4 Introduction to CKD 5 Key Facts CKD cannot be cured but treatment can prevent or delay the progression of CKD, reduce or prevent the development of complications, and reduce the risk of cardiovascular disease CKD progresses to end-stage renal disease (ESRD) only in a small but significant percentage of people Introduction to CKD CKD Public Health 6 Introduction to CKD 7 Paradigm Shift In Nephrology Recent change in focus in renal medicine from treatment of established kidney disease to earlier identification and prevention of kidney disease Why? Late presentation of people with kidney failure increases morbidity, mortality and associated healthcare costs Introduction to CKD 8 Paradigm Shift In Nephrology In 2005 the Department of Health in UK published the Renal National Service Framework (NSF) (-designed to help the NHS carry on improving the quality of healthcare) In order to improve early diagnosis of kidney disease NSF came up with one key recommendation: Whenever creatinine was measured the Laboratory has to report eGFR (estimated Glomerulofiltration rate) using the MDRD equation Introduction to CKD Why MDRD Equation? 9 Introduction to CKD 10 Why MDRD Equation? Levey and colleagues derived a predictive equations for eGFR using 4 variables (serum creatinine, age, sex, and race) from the 1628 patients included in the modification of diet in renal disease (MDRD) study and undergoing renal clearance of 125I Iothalamate as a reference method Introduction to CKD Renal Function After NS Bricker et al, in BM Brenner (ed): Brenner and Rector's The Kidney, 6th ed. Philadelphia, Saunders, 2000. Curve A - substances such as creatinine and urea Curve B - urate, PO4, and K+ Curve C – Na+ 11 Introduction to CKD 12 Renal Function Assessment vs. Screening for Renal Disease • A gold standard marker for directly measuring GFR should be • Freely filtered by the glomerulus, • Should not be bound to plasma proteins, • Must be excreted unchanged and not be subject to either tubular secretion (unlike Creatinine) or absorption • Inulin clearance and other exogenous markers such as radiolabeled isotopes (51Cr EDTA, 99mTc DTPA or 125I Iothalamate) and non-radioactive contrast agents (Iothalamate or Iohexol) • These methods of measuring GFR are unsuitable for widespread identification of CKD in the ‘at risk’ population Introduction to CKD 13 Estimating GFR Current practice is to estimate GFR from serum creatinine • This is calibrated to the internationally standardised isotope dilution mass spectrometry (IDMS) methodology using the IDMS-related Modification of Diet in Renal Disease (MDRD) equation eGFR (mL/min/1.73 m2) = GFR = 175 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female) Introduction to CKD 14 Why MDRD Equation? • The normal serum creatinine reference interval does not necessarily reflect a normal GFR for a patient • MDRD Study equation employs age, gender, and race therefore CKD can be detected despite a “normal” serum creatinine concentration Introduction to CKD 15 Limitations Of The MDRD Equation • Non-Adults • Individuals with unstable creatinine concentrations • Persons with extremes in muscle mass and diet • ? eGFR > 60ml/min !!! • ? Older patients • ? Asians • ? Transplant patients eGFR (mL/min/1.73 m2) = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American) Introduction to CKD Limitations Of The MDRD Equation Non-adults Individuals with unstable creatinine concentrations Persons with extremes in muscle mass and diet eGFR >60ml/min Older patients Asians Transplant patients 16 Introduction to CKD 17 ‘A New Kid On The Block’ • The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation is a new equation, • Published in 2009 • Estimates glomerular filtration rate (GFR) from serum creatinine, age, sex, and race for adults age ≥ 18 years Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF, 3rd, Feldman HI, et al. A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009;150(9):604-12 Introduction to CKD 18 CKD-EPI Vs. MDRD Equation The CKD-EPI equation is based on the same four variables as the MDRD Study equation but uses a 2-slope "spline" to model the relationship between GFR and serum creatinine, age, sex, and race. (hence applies different coefficients to the same 4 variables used in the MDRD Study equation) GFR = 141 × min (Scr /κ, 1)α × max(Scr /κ, 1)-1.209 × 0.993Age × 1.018 [if female] × 1.159 [if black] Scr is serum creatinine in mg/dL, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr /κ or 1, and max indicates the maximum of Scr /κ or 1 Introduction to CKD 19 CKD-EPI Vs. MDRD Equation The CKD-EPI equation classified fewer individuals as having CKD and more accurately categorized the risk for mortality and ESRD than did the MDRD Study equation across a broad range of populations Kunihiro Matsushita et al, Comparison of Risk Prediction Using the CKD-EPI Equation and the MDRD Study Equation for Estimated Glomerular Filtration Rate, JAMA. 2012;307(18):1941-1951 Introduction to CKD 20 To Complicate Further To make matters even more complicated there is another Biomarker for renal function: Cystatin C • A protein containing a chain of 120 amino acids • A member of the cysteine proteinase inhibitor family • Produced at a constant rate by all nucleated cells • Found in virtually all tissues and body fluids Serum levels of cystatin C are a more precise test of kidney function than serum creatinine levels (Cystatin C levels are less dependent on age, sex, race and muscle mass compared to creatinine and are not tubular secreted) Introduction to CKD 21 New Recommendations Clinical labs should use: • The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) • Consider using eGFR cystatinC to confirm the diagnosis of CKD in people with : • An eGFR creatinine of 45–59 ml/min/1.73 m2, • For at least 90 days and • No proteinuria (albumin:creatinine ratio) • ACR less than 3mg/mmol Introduction to CKD 22 New Recommendations • Do not diagnose CKD in people with: • An eGFR creatinine of 45–59ml/min/1.73m2 • An eGFR cystatinC of more than 60 ml/min/1.73 m2 • With no other marker of kidney disease Introduction to CKD Limitations Of The MDRD Equation Non-adults Individuals with unstable creatinine concentrations Persons with extremes in muscle mass and diet eGFR >60ml/min !!! Older patients Asians Transplant patients 23 Introduction to CKD 24 Can any of the eGFR equations reliably be used in Transplant patients ? Not really… • eGFR unreliable in patients with significant change in renal function in short period of time • greater heterogeneity in creatinine generation among all transplant recipients (length of time spent on dialysis, number of acute rejections or cumulative steroid dose seem to be a predictors of muscle mass index in transplant recipients independent of BW and what about nephron mass transplanted to the recipient ?) • few studies found that the predicting equations were less accurate within the first year of transplantation and that they were quite limited in assessing GFR decline over time Introduction to CKD 25 Why Do We Need eGFR? To diagnose, classify and stage CKD • eGFR is an independent predictor of all-cause and cardiovascular mortality and kidney failure in a wide range of populations • Level of eGFR provides a guide to management, including stratification of risk for progression and complications of CKD • Risk stratification is used to inform appropriate treatments and the intensity of monitoring and patient education Introduction to CKD Classifying CKD 26 Introduction to CKD 27 CV mortality risk increases with declining renal function1 4.35 Relative risk of CV death* 4.38 5 3.01 4 2.36 3 2.19 2.42 2 1.48 2.18 15–59 1 0 1.00 Macroalbuminuria ≥90 Microalbuminuria eGFR (ml/min/1.73m2) 60–89 Normal NHANES III 1988–2000 * Adjusted for age, sex, race/ethnicity, previous CV disease, blood pressure category, use of antihypertensive medication, diabetes mellitus, smoking status, body mass index, physical activity level, low density lipoprotein and high density lipoprotein cholesterol, log triglyceride level, and C-reactive protein category 1. Adapted from: Astor BC, et al. Am J Epidemiol 2008;167:1226–34. Introduction to CKD 28 CV mortality risk increases with declining renal function1 Relative risk of CV death* 4.35 4.38 5 3.01 4 2.36 3 2.42 2.18 2 1.48 2.19 15–59 1 1.00 0 Macroalbuminuria ≥90 Microalbuminuria eGFR (ml/min/1.73m2) 60–89 Normal NHANES III 1988–2000 * Adjusted for age, sex, race/ethnicity, previous CV disease, blood pressure category, use of antihypertensive medication, diabetes mellitus, smoking status, body mass index, physical activity level, low density lipoprotein and high density lipoprotein cholesterol, log triglyceride level, and C-reactive protein category 1. Adapted from: Astor BC, et al. Am J Epidemiol 2008;167:1226–34. Introduction to CKD 29 Risk Marker of CKD • Degree of renal impairment and proteinuria are regarded as an independent marker for worsening of renal function and cardiovascular disease hence considered to be a risk markers for CKD • Risk of adverse outcomes from CKD, including progression of CKD, is substantially increased below a GFR of 45 ml/min/1.73 m2 irrespective of urine ACR • Urine ACR >30 mg/mmol suggests increased risk of adverse outcome, irrespective of GFR, including progression of CKD Introduction to CKD Classification of CKD 30 Introduction to CKD 31 CKD Progression And Risk Categories Group GFR and albuminuria categories with similar relative risk for CKD progression into risk categories Introduction to CKD CKD Incidence and Prevalence 32 Introduction to CKD 33 NHANES 2005-2010 Distribution of NHANES 2005–2010 participants with diabetes, cardiovascular disease and single-sample markers of CKD NHANES participants 2005–2010, age 20 & older; single-sample estimates of eGFR & ACR USRDS ADR 2013 Introduction to CKD 34 Prevalence of CKD In USA • • • 14% of adults ≥ 20 years old • 6.7% with estimated glomerular filtration rate (GFR) < 60 mL/minute/1.73 m2 • 9.4% with albumin to creatinine ratio ≥ 30 mg/g Prevalence by age (any stage) • 5.7% at age 20-39 years • 9.1% at age 40-59 years • 35% at age ≥ 60 years Based on National Health and Nutrition Examination Survey (NHANES) 2005-2010 United States Renal Data System 2013 Atlas of Chronic Kidney Disease Introduction to CKD 35 CKD In England In an age standardised cross sectional point prevalence study of over 130,000 adults from Kent, Surrey and Manchester • Prevalence of people with an estimated GFR <60 ml/min/1.73 m2 (CKD stages 3-5) was 8.5%, • Those with CKaD were more likely to have hypertension, diabetes and cardiovascular disease compared to people with GFR>60 ml/min/1.73 m2, • Prevalence of CKD rose with age and female gender Stevens PE, O'donoghue DJ, de LS, Van VJ, Klebe B, Middleton R et al. Chronic kidney disease management in the United Kingdom: NEOERICA project results. Kidney International. 2007; 72(1):92-99 Introduction to CKD 36 CKD In England CKD Stage Male Female 1 3% 3% 2 6% 3% 3-5 5% 7% Total 14% 13% Health Survey for England: Adult CKD prevalence www.ic.nhs.uk/statistics-and-data-collections/health-and-lifestyles-related-surveys/health-survey-for-england Introduction to CKD CKD Causes 37 Introduction to CKD 38 NHANES 2005-2010 Distribution of markers of CKD in NHANES participants with diabetes and hypertension, 2005–2010 NHANES 1988–1994 & 2005–2010 participants age 20 & older; single sample estimates of eGFR & ACR. eGFR calculated using the CKD-EPI equation. USRDS ADR 2013 Introduction to CKD 39 NHANES 2005-2010 Distribution of markers of CKD in NHANES participants with diabetes and hypertension, 2005–2010 NHANES 1988–1994 & 2005–2010 participants age 20 & older; single sample estimates of eGFR & ACR. eGFR calculated using the CKD-EPI equation. USRDS ADR 2013 Introduction to CKD 40 Cardiovascular Risk in CKD: Chicken or Egg? Relationship between metabolic syndrome risk factors and prevalence rate of CKDs in the NHANES III survey (1988-94, USA sample of 33,994 persons) Introduction to CKD AGE and CKD 41 Introduction to CKD 42 Cause of CKD To keep it simple: it seems • 2/3 of patients have ischaemic and/or hypertensive nephropathy (“Arteriopath patients”) • 1/3 of patients have “other” renal disease (e.g ADPKD, Glomerulonephritis, Obstructive Nephropathy, renal vascular disease, drug induced renal disease) Introduction to CKD Outcomes of CKD 43 Introduction to CKD 44 Life expectancy of NHANES participants with or without CKD, 1999–2004 NHANES 1999–2004 participants age 20 & older; single sample estimates of eGFR & ACR. eGFR calculated using the CKD-EPI equation. USRDS ADR 2013 Introduction to CKD 45 CKD Prognosis Summary of continuous meta-analysis (adjusted relative risk (RR)) for general population cohorts with albumin-to-creatinine ratio (ACR). The three lines represent urine ACR of <30 mg/g or dipstick negative and trace (blue), urine ACR 30–299 mg/g or dipstick 1+ positive (green), and urine ACR greater than or equal to300 mg/g or dipstick greater than or equal to2+ positive (red). All results are adjusted for covariates and compared with reference point of eGFR of 95 ml/min per 1.73 m2 and ACR of <30 mg/g or dipstick negative (diamond). Each point represents the pooled relative risk from a meta-analysis. Solid circles indicate statistical significance compared with the reference point (P<0.05); triangles indicate non-significance. Red arrows indicate eGFR of 60 ml/min per 1.73 m2, threshold value of eGFR for the current definition of chronic kidney disease (CKD). HR, hazards ratio; OR, odds ratio. Introduction to CKD 46 Take Home Messages • Older CKD patients are far more likely to die from CVD event than to approach ESRD • The risk of cardiovascular event/death dwarfs the risk of eventually requiring renal replacement therapy. • This risk varies with age and other factors: older patients with less severe CKD are more likely to die (usually due to cardiovascular disease) before needing renal replacement therapy, while younger patients are more likely to ultimately need renal replacement therapy • Both decreased GFR and increased proteinuria increase the risk of cardiovascular disease Introduction to CKD CKD Costs 47 Introduction to CKD 48 CKD Costs in USA Per Person Per Year $8,245 per year for those without CKD • $11,103 for the average Medicare patient $27,715 Patients with CKD of Stages 4–5 and other complications, $23,128 average CKD patient In 1993, total costs for Medicare patients age 65 and older with CKD accounted for just 3.8 % of overall Medicare expenditures. • In 2011, costs for these patients reached $45.5 billion, 18 % of total Medicare dollars www.usrds.org/2013/view/v1_07.aspx Introduction to CKD 49 Overall PPPY costs in CKD patients, by CKD diagnosis code, dataset, & year 585.1 CKD Stage 1 585.2 CKD Stage 2 (mild) 585.3 CKD Stage 3 (moderate) 585.4 CKD Stage 4 (severe) 585.5 CKD Stage 5 (requires chronic dialysis) Point prevalent Medicare patients age 65 & older (5 percent Medicare sample, 7.2–4) & Truven Health MarketScan patients age 50–64 (7.2). Includes Part D. http://www.usrds.org/2013/view/v1_07.aspx Introduction to CKD Overall expenditures for CKD in the Medicare population age 65 & older Point prevalent Medicare CKD patients age 65 & older; costs are total expenditures per calendar year http://www.usrds.org/2013/view/v1_07.aspx 50 Introduction to CKD 51 CKD Costs UK • The total cost of CKD in England in 2009–10 was estimated at £1.44 - £1.45 billion • Approximately 1.3% of all NHS spending in that year > 50% of this amount was spent on renal replacement therapy for the 2% of people with CKD that progresses to kidney failure • Approximately 7000 excess strokes and 12,000 excess myocardial infarctions occurred in people with CKD in 2009–10 (relative to an age- and gender-matched population without CKD), with an estimated cost of between £174 and £178 million Kerr M, Bray B, Medcalf J et al. (2012) Estimating the financial cost of chronic kidney disease to the NHS in England. Nephrology Dialysis Transplantation. 27 (Suppl. 3): iii73–80 Introduction to CKD Management of CKD 52 Introduction to CKD Management of CKD Treatment of reversible causes of renal failure Preventing or slowing the progression of renal disease Treatment of the complications of renal failure 53 Introduction to CKD 54 Treatment of reversible causes of renal failure Avoid nephrotoxic drugs Improve renal perfusion (e.g. Cardio renal syndrome) Treat urinary tract obstruction Introduction to CKD 55 Preventing or slowing the progression of renal disease Optimise treatment of the underlying disease (e.g. Diabetes mellitus) Blood pressure control Lifestyle modification (vicious circle Obesity, physical inactivity, smoking and Diabetes/hypertension) Aim to reduce Proteinuria Diet restriction Introduction to CKD 56 Treatment of the complications of renal failure Reducing cardiovascular disease Treating hypertension Preventing Hyperkalaemia, Metabolic Acidosis Preventing/Treating Mineral and Bone Disease and sHPTH Managing volume overload Renal Anaemia Introduction to CKD 57 References • Levey et al (2011) Kidney International 80, 17–28 • Shah et al (2015) Recent Advances in Understanding the Pathogenesis of Atherosclerosis in CKD Patients, J. Ren. Nutr., S1051-2276 • Mazzaferro et al (2014) News on Biomarkers in CKD-MBD, Semin. Nephrol., 34 (6), 598-611 • Stevens et al (2014) Integrating Guidelines, CKD, Multimorbidity, and Older Adults, Am. J. Kidney Dis., S0272-6386 • Matsushita K et al (2010) Association of estimated glomerular filtration rate and albuminuria with all-cause and cardiovascular mortality in general population cohorts: a collaborative meta-analysis, Lancet, 375 (9731), 2073 FACULTY OF HEALTH & LIFE SCIENCES – CPD Institute for Learning & Teaching Faculty of Health & Life Sciences Room 2.16A, 4th Floor Thompson Yates Building Brownlow Hill Liverpool L69 3GB www.liv.ac.uk/learning-and-teaching/cpd A MEMBER OF THE RUSSELL GROUP