1. CKD Conservative care and preparation for dialysis UK Renal Registry 2013 Annual Audit Meeting Dr Anirudh Rao Registrar, UK Renal Registry

2. Scope of the talk Background CK MAPPS EQUAL My Research Future

3. Background-Aging Population

4. Background-UKRR data

5. Survival Age group1 year2 year3 year4 year5 year 18-34 97.79 94.90 92.21 91.31 89.27 35-44 94.67 90.95 88.26 84.38 82.88 45-54 91.82 86.24 80.39 75.99 71.21 55-64 86.67 78.69 72.72 66.04 61.67 65-69 82.25 70.40 60.46 48.38 40.72 70-74 73.90 62.94 53.95 43.26 34.55 75-79 69.18 54.18 41.81 33.77 27.36 80-84 67.47 50.93 37.98 27.80 19.52 85+ 53.37 40.03 26.69 21.24 14.71

6. Literature survey: Summary graph of survival of elderly patients with ESRD in previous studies. Carson R C et al. CJASN 2009;4:1611-1619 ©2009 by American Society of Nephrology

7. UK evidence

8. Summary of published literature Limited data in UK comparing CKM vs RRT Relatively small (no with CKM 29-77) > single centres Retrospective-- issues of start time, inclusion (variable age, +/- late referred), limited outcomes (>survival), selection bias, handling late referrers Key  Survival depend on when you start clock, survival differences depend on what you adjust for  Limited evidence of any dialysis benefit once adjust for function/comorbidity, no data on costs but some evidence less hospitalisation/travel, limited data on EoL care some evidence more home or hospice death

9. Why is conservative care data different ?

10. Conservative care data-Challenges We need data on CKD stage 5 patients Un-referred chronic kidney disease. Spectrum of conservative care management. Who and where is care provided? Variation Across UK

11. CKMAPPS Professor Paul Roderick, Dr Hugh Rayner, et al To describe the variation in conservative kidney management, its scale compared to dialysis, service developments and future plans. To explore how and when decisions are made about treatment options for older patients (75+) with CKD5 and factors that influence decisions to opt for CKM. To describe the interface between renal units and primary care in managing CKD5 patients. To explore feasibility of RCT or observational study of CKM vs dialysis

12. Study components Phase 1 Qualitative study of clinicians and patients in 9 units Phase 2 National survey of practice patterns in all renal units Sub components – GP Referral patterns in 9 units, exploration for non referral in 4 units (4x25 pts) – Health economics address optimum methods to collate data on resource use/costs

13. Dr Fergus Caskey, national lead investigator Dr A Rao, clinical research fellow Mrs Helen McNally, lead research nurse North Bristol NHS Trust The EQUAL Study

14. HR = 1.66 (0.95-2.89) P = 0.07 Timely Late Incident dialysis patients who received predialysis care and had a measure of renal function and nutrition 0-4 weeks prior to start. Timely n = 159 7.1 ml/min/1.73m2, Kt/V urea >= 2.0 or nPNA >= 0.8 g/kg/d Late n = 94 4.9 ml/min/1.73m 2, Kt/V urea < 2.0 and nPNA >= 0.8 g/kg/d Background: the “timely start” idea

15. Background: The IDEAL Study

16. 2982 new predialysis patients Randomization Planned start at eGFR CG 10-14 ml/min (or earlier because of symptoms) Planned start at eGFR CG 5-7 ml/min (or earlier because of symptoms) Realized start at eGFR CG 12 ml/min (MDRD 9.0 ml/min) Realized start at eGFR CG 9.8 ml/min (MDRD 7.8 ml/min) Mortality: 10.2 / 100 py CVD events: 10.9 Mortality: 9.8 / 100 py CVD events: 8.8 “Early start”“Late start” RR 1.04 (95% CI 0.83-1.30) RR 1.23 (95% CI 0.97-1.46)  Early start not better survival  More CVD events??? Background: The IDEAL Study

17. Research objectives The primary objective is: To determine the level of kidney function (blood results, physical signs or symptoms) at which overall quantity and quality of life is optimised by starting RRT in patients aged 65+.

18. Research objectives The secondary objectives are to determine: a.How uraemic signs and symptoms develop during the progression of advanced CKD b. The optimal laboratory measure of kidney function in advanced CKD at which to start RRT (in terms of optimising quantity and quality of life) c. The factors that influence nephrologists, patients and carers when deciding whether/ when to start RRT d. Whether patients are satisfied with decision making in relation to whether/ when to start RRT

19. Study design Prospective, observational cohort study Six countries – Germany, Italy, The Netherlands, Poland, Sweden, The UK UK- 9 centres Individuals aged 65+ with incident eGFR 20 – Case note review, physical assessment, patient questionnaires – Routine blood/ urine samples – Additional blood/ urine at baseline and start of dialysis/ eGFR 10 Target recruitment (over 2yr): 3,000 total (700 in UK)

20. Inclusion Criteria 1. Aged 65+ 2. Attending nephrology clinic with a first eGFR of 20 ml/min/1.73m2 (or less if presenting late) within the last 6 months, regardless of subsequent eGFRs

21. Exclusion Criteria 1. A history of dialysis or kidney transplantation 2. The current decrease in eGFR is thought to be due to an acute event with eGFRs prior to this event not having been ≤ 30 for at least 3months 3. Unable to give informed consent or communication problems (including limited English language)

23. My Research Recruitment into studies EQUAL PILOT Generalizability

24. My Research The methodology will be embedded within EQUAL. Qualitative Arm Quantitative Arm

25. Registry perspective & Future CKD data CKMAPPS & EQUAL will inform how registry will collect conservative care data Research/PhD