Abstract
Clinical trials are carried out to develop therapies that are best for our patients. Most clinicians would agree that the best therapies are those that have the greatest efficacy and the least toxicity, i.e. those that have the highest benefitto-risk ratios. End-points in clinical trials are clearly defined events or measurements that reflect the efficacy and/or toxicity of therapy; they generally need to be understandable and reproducible and must occur frequently enough to allow therapy to be tested in a reasonably small number of patients over a relatively short period of time to make a clinical trial feasible.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
The Canadian Multicentre Transplant Study Group. A randomized clinical trial of cyclosporine in cadaveric renal transplantation. N. Engl. J. Med. 1986; 314: 1219–1225
European Multicentre Trial Group. Cyclosporin in cadaveric renal transplantation: one-year follow-up of a multicentre trial. Lancet. 1983; 2: 986–998.
West M, Sutherland DER, Matas AJ. Kidney transplant recipients who die with functioning grafts. Serum creatinine level and cause of death. Transplantation. 96 A.D.; 62: 1029–1030.
Hirata M, Cho YW, Cecka JM et al. Patient death after renal transplantation - an analysis of its role in graft outcome Proposed consensus for definitions and end-points for clinical trials of acute kidney transplant rejection. Transplantation. 1996; 61: 1479–1483.
Guttmann RD, Soulillou JP, Moore LW et al. Proposed consensus for definitions and endpoints for clinical trials of acute kidney transplant rejection. Am. J. Kidney Dis. 1998; 31 (Suppl 1): S40–S46.
Gaber LW, Moore LW, Gaber AO et al. Utility of standardized histological classification in the management of acute rejection. 1995 Efficacy End-points Conference. Transplantation. 1998; 65: 376–380.
Halloran P, Mathew T, Tomlanovich S, Groth C, Hooftman L, Barker C. Mycophenolate mofetil in renal allograft recipients. A pooled efficacy analysis of three randomized, double-blind, clinical studies in prevention of rejection. Transplantation. 1997; 63: 39–47.
Mathew TH. A blinded, long-term, randomized multicenter study of mycophenolate mofetil in cadaveric renal transplantation: results at three years. Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. Transplantation. 1998; 65: 1450–1454.
Braun WE, Popowniak KL, Nakamoto S, Gifford RWJ, Straffon RA. The fate of renal allografts functioning for a minimum of 20 years. Transplantation. 1995; 60: 784–790.
Peddi VR, Whiting J, Weiskittel PD, Alexander JW, First MR. Characteristics of long-term renal transplant survivors. Am. J. Kidney Dis. 1998; 32: 101–106.
Massy ZA, Guijarro C, Wiederkehr MR, Ma JZ, Kasiske BL. Chronic renal allograft rejection: immunologic and nonimmunologic risk factors. Kidney Int. 1996; 49: 518–524.
Matas AJ. Acute rejection is a major risk factor for chronic rejection. Transplant. Proc. 1998; 30: 766–1768.
Kasiske BL, Kalil RSN, Lee HS, Rao KV. Histopathologic findings associated with a chronic, progressive decline in renal allograft function. Kidney Int. 1991; 40: 514–524.
Lewis EJ, Hunsicker LG, Bain RP, Rohde RD. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. N. Engl. J. Med. 1993; 329: 1456–1462.
Klahr S. Levey AS, Beck GJ et al. The effects of dietary protein restriction and blood-pressure control in the progression of chronic renal disease. N.Engl. Med. 1994; 330: 877–884.
Kasiske BL, Massy ZA, Guijarro C, Ma JZ. Chronic renal allograft rejection and clinical trial design. Kidney Int. 1995; 48 (Suppl 52): S116–S119.
Isoniemi H, Nurminen M, Tikkanen M et al. Risk factors predicting chronic rejection of renal allograft. Transplantation. 1994; 57: 68–72.
Dimény E, Wahlberg J, Larsson E, Fellström B. Can histopathological findings in early renal allograft biopsies identify patients at risk for chronic vascular rejection? Clin. Transplant. 1995; 9: 79–84.
Serön D, Moreso F, Boyer J et al. Early protocol renal allograft biopsies and graft outcome. Kidney Int. 1997; 51: 310–316.
Fioretto P, Steffes MW, Mihatsch MJ, Strom EH, Sutherland DER, Mauer M. Cyclosporine associated lesions in native kidneys of diabetic pancreas transplant recipients. Kidney Int. 1995; 48: 489–495.
Ebbutt AF Frith L. Practical issues in equivalence trials. Stat. Med. 1998; 17: 1691–1701.
Jones B, Jarvis P, Lewis JA, Ebbutt AE Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996; 313: 36–39.
Testa MA, Simonson DC. Assessment of quality-of-life outcomes. N. Engl. J. Med. 1996; 334: 835–840.
Shield CF III, McGrath MM, Goss TE Assessment of health-related quality of life in kidney transplant patients receiving tacrolimus (FK506)-based versus cyclosporine-based immunosuppression. FK506 Kidney Transplant Study Group. Transplantation. 1997; 64: 1738–1743.
Hunsicker LG, Bennett LE. Design of trials of methods to reduce late renal allograft loss: the price of success. Kidney Int. Suppl. 1995; 52: S120–S123.
Editor information
Rights and permissions
Copyright information
© 1999 Springer Science+Business Media Dordrecht
About this chapter
Cite this chapter
Kasiske, B.L. (1999). Surrogate end-points for clinical trials in renal transplantation. In: Cochat, P., Traeger, J., Merieux, C., Derchavane, M. (eds) Immunosuppression under Trial. Transplantation and Clinical Immunology, vol 31. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-4643-2_5
Download citation
DOI: https://doi.org/10.1007/978-94-011-4643-2_5
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-010-5960-2
Online ISBN: 978-94-011-4643-2
eBook Packages: Springer Book Archive