Nephrology
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Determining the number of subjects required for a study is a critical component when planning a research project. An adequate number of patients are needed in order to be able to answer the research question of interest with a degree of certainty. ⋯ The primary aim is to demystify the sample size section in published clinical trials. Some of the difficulties in determining the sample size correctly are also highlighted and some good practices recommended.
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Clinical Trial
Benefit and cost from the long-term use of cyclosporine-A in idiopathic membranous nephropathy.
Idiopathic membranous nephropathy (IMN), the most common cause of nephrotic syndrome in adults, is usually treated by cyclosporin A (CsA). Estimation of the effectiveness of long-term use of CsA in the remission and relapse rate of nephrotic syndrome along with histological changes in repeat renal biopsies was the aim of the study. ⋯ Low doses of CsA with prednisolone induce remission of nephrotic syndrome in most idiopathic membranous nephropathy patients. Although typical features of CsA nephrotoxicity are not observed, significant deterioration of histological lesions occurs with time, even in patients with remission. Long-term use of CsA should be examined with caution.
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Acute kidney injury (AKI) is a common and serious condition, the diagnosis of which currently depends on functional markers such as serum creatinine measurements. Unfortunately, creatinine is a delayed and unreliable indicator of AKI. The lack of early biomarkers of structural kidney injury (akin to troponin in acute myocardial injury) has hampered our ability to translate promising experimental therapies to human AKI. ⋯ In addition, it is hoped that the use of sensitive and specific biomarkers such as NGAL as endpoints in clinical trials will result in a reduction in required sample sizes, and hence the cost incurred. Furthermore, predictive biomarkers like NGAL may play a critical role in expediting the drug development process. However, given the complexity of AKI, additional biomarkers (perhaps a panel of plasma and urinary biomarkers) may eventually need to be developed and validated for optimal progress to occur.
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Review
Timely initiation of dialysis for chronic kidney disease: perspective from four Asian countries.
Recommendations about when to initiate dialysis for end-stage kidney failure have been made by a number of expert groups. These recommendations have led to changes in clinical practice, yet they are not based on high level evidence. ⋯ One of the main determinants of optimal initiation of dialysis is the time of referral of the patient to a nephrologist or a renal unit. In particular, early referral of patients with chronic kidney disease allows a planned initiation of dialysis, using from the start permanent vascular or peritoneal dialysis access.