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      Therapeutic Strategies for Clinical Trials Targeting Renal Recovery


      Nephron Clinical Practice

      S. Karger AG

      Acute kidney injury, Acute respiratory distress syndrome, Best care practices, Renal recovery

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          Although at present we have developed consensus definitions for acute kidney injury (AKI) and there is a major focus on the treatment and prevention of AKI in high-risk populations, little is known about renal recovery per se and the impact of therapies on renal recovery. Here, we will focus on the specifics of clinical trial design relevant to studies of AKI recovery. While certain design considerations will be common to all trials, others elements will be more specific for studies focused on best practice or novel therapeutics. We will first discuss clinical trial considerations for all studies followed by specific proposals for best practice trials and therapy trials. Other presentations during this round table have focused on other aspects that are highly important for clinical trial design, including definitions for recovery, the potential use of biomarkers, as well as clinical trial endpoints, so we will not address these issues here.

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          Most cited references 8

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          Dialysis-requiring acute renal failure increases the risk of progressive chronic kidney disease.

          To determine whether acute renal failure (ARF) increases the long-term risk of progressive chronic kidney disease (CKD), we studied the outcome of patients whose initial kidney function was normal or near normal but who had an episode of dialysis-requiring ARF and did not develop end-stage renal disease within 30 days following hospital discharge. The study encompassed 556,090 adult members of Kaiser Permanente of Northern California hospitalized over an 8 year period, who had pre-admission estimated glomerular filtration rates (eGFR) equivalent to or greater than 45 ml/min/1.73 m(2) and who survived hospitalization. After controlling for potential confounders such as baseline level of eGFR and diabetes status, dialysis-requiring ARF was independently associated with a 28-fold increase in the risk of developing stage 4 or 5 CKD and more than a twofold increased risk of death. Our study shows that in a large, community-based cohort of patients with pre-existing normal or near normal kidney function, an episode of dialysis-requiring ARF was a strong independent risk factor for a long-term risk of progressive CKD and mortality.
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            The risk of acute renal failure in patients with chronic kidney disease.

            Few studies have defined how the risk of hospital-acquired acute renal failure varies with the level of estimated glomerular filtration rate (GFR). It is also not clear whether common factors such as diabetes mellitus, hypertension and proteinuria increase the risk of nosocomial acute renal failure independent of GFR. To determine this we compared 1,746 hospitalized adult members of Kaiser Permanente Northern California who developed dialysis-requiring acute renal failure with 600,820 hospitalized members who did not. Patient GFR was estimated from the most recent outpatient serum creatinine measurement prior to admission. The adjusted odds ratios were significantly and progressively elevated from 1.95 to 40.07 for stage 3 through stage 5 patients (not yet on maintenance dialysis) compared to patients with estimated GFR in the stage 1 and 2 range. Similar associations were seen after controlling for inpatient risk factors. Pre-admission baseline diabetes mellitus, diagnosed hypertension and known proteinuria were also independent risk factors for acute kidney failure. Our study shows that the propensity to develop in-hospital acute kidney failure is another complication of chronic kidney disease whose risk markedly increases even in the upper half of stage 3 estimated GFR. Several common risk factors for chronic kidney disease also increase the peril of nosocomial acute kidney failure.
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              Acute kidney injury episodes and chronic kidney disease risk in diabetes mellitus.

              Prior studies have examined long-term outcomes of a single acute kidney injury (AKI) event in hospitalized patients. We examined the effects of AKI episodes during multiple hospitalizations on the risk of chronic kidney disease (CKD) in a cohort with diabetes mellitus (DM). A total of 4082 diabetics were followed from January 1999 until December 2008. The primary outcome was reaching stage 4 CKD (GFR of 0.3 mg/dl or a 1.5-fold increase in creatinine relative to admission. Cox survival models examined the effect of first AKI episode and up to three episodes as time-dependent covariates, on the risk of stage 4 CKD. Covariates included demographic variables, baseline creatinine, and diagnoses of comorbidities including proteinuria. Of the 3679 patients who met eligibility criteria (mean age = 61.7 years [SD, 11.2]; mean baseline creatinine = 1.10 mg/dl [SD, 0.3]), 1822 required at least one hospitalization during the time under observation (mean = 61.2 months [SD, 25]). Five hundred thirty of 1822 patients experienced one AKI episode; 157 of 530 experienced ≥2 AKI episodes. In multivariable Cox proportional hazards models, any AKI versus no AKI was a risk factor for stage 4 CKD (hazard ratio [HR], 3.56; 95% confidence interval [CI], 2.76, 4.61); each AKI episode doubled that risk (HR, 2.02; 95% CI, 1.78, 2.30). AKI episodes are associated with a cumulative risk for developing advanced CKD in diabetes mellitus, independent of other major risk factors of progression.

                Author and article information

                Nephron Clin Pract
                Nephron Clinical Practice
                S. Karger AG
                September 2014
                24 September 2014
                : 127
                : 1-4
                : 113-116
                Divisions of Nephrology and Critical Care Medicine, Departments of Medicine and Anesthesia, University of California, San Francisco, Calif., USA
                Author notes
                *Assoc. Prof. Kathleen D. Liu, MD, PhD, MAS, Division of Nephrology, Department of Medicine, Critical Care Medicine, Department of Anesthesia, University of California, Box 0532, San Francisco, CA 94143 (USA), E-Mail
                363703 Nephron Clin Pract 2014;127:113-116
                © 2014 S. Karger AG, Basel

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                Page count
                Figures: 1, Pages: 4


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