American journal of kidney diseases : the official journal of the National Kidney Foundation
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Randomized Controlled Trial Multicenter Study Comparative Study Controlled Clinical Trial
Rationale and design of the TEMPO (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes) 3-4 Study.
Current management of autosomal dominant polycystic kidney disease (ADPKD) is focused on treating disease complications, not on slowing cyst development or preventing progression to kidney failure. Tolvaptan, a selective vasopressin V2 (vasopressin 2) receptor antagonist, has been proved to inhibit kidney cyst growth and preserve kidney function in multiple animal models of polycystic kidney disease. The TEMPO (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes) 3-4 Study will examine the long-term effectiveness and safety of tolvaptan in patients with ADPKD. We report baseline characteristics and revised power calculations for the trial. ⋯ This randomized trial is the largest clinical study of a proposed ADPKD intervention to date. It targets patients with ADPKD with early disease who are projected to have rapid cyst growth and accelerated outcomes. Blockade of vasopressin V2 receptor is hypothesized to inhibit cyst growth, thereby delaying additional adverse clinical outcomes.
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Comparative Study Clinical Trial
Immunogenicity and efficacy in hemodialysis patients of an AS03(A)-adjuvanted vaccine for 2009 pandemic influenza A(H1N1): a nonrandomized trial.
Hemodialysis patients have a reduced response to vaccinations because of uremia-related immune dysfunction. To increase the immunogenicity of vaccines, antigens can be formulated with adjuvants. The new tocopherol-containing adjuvant system AS03(A) has not been tested yet in patients with end-stage renal disease. ⋯ Pandemic H1N1 vaccine adjuvanted with AS03(A) is immunogenic, effective, and safe in hemodialysis patients.
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Multicenter Study Comparative Study
The relationship between kidney function and long-term graft survival after kidney transplant.
Whether chronic kidney disease (CKD) staging provides a useful framework for predicting outcomes after kidney transplant is unclear. ⋯ CKD stages validated in the general population provide a useful framework for predicting outcomes after kidney transplant.
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Comparative Study
Association of plasma aldosterone with cardiovascular mortality in patients with low estimated GFR: the Ludwigshafen Risk and Cardiovascular Health (LURIC) Study.
We have previously shown that plasma aldosterone levels within the physiologic reference range predicted increased all-cause and cardiovascular disease (CVD) mortality in patients referred for coronary angiography. Decreased kidney function is associated with a marked increase in CVD mortality that is not explained fully by known cardiovascular risk factors. We hypothesized that level of kidney function might modify the association between plasma aldosterone level and CVD mortality. ⋯ Our findings suggest that the association of higher plasma aldosterone concentration with overall CVD mortality and sudden cardiac death is stronger for patients with lower kidney function.