Journal of nephrology
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Journal of nephrology · Oct 2014
Randomized Controlled Trial Multicenter Study Comparative StudyThe extent of informed decision-making about starting dialysis: does patients' age matter?
A growing number of elderly patients with end-stage renal disease start dialysis. We examined elderly (≥65 years) patients' views about their decision-making experience after starting dialysis in comparison with patients aged 50-64 years, and patients ≤49 years. ⋯ Informed decision-making is significantly poorer in patients aged 65 years or older than in younger patients. Clinicians should communicate clearly about the benefits and burdens of dialysis to older adults and provide an opportunity for them to understand the significant trade-offs that dialysis may require.
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Journal of nephrology · May 2012
Randomized Controlled Trial Multicenter StudyA prospective, multicenter, randomized, controlled study: the correction of metabolic acidosis with use of bicarbonate in Chronic Renal Insufficiency (UBI) Study.
A Cochrane Collaboration review (Roderick, Cochrane Data base of systemic reviews 2007, DOI 10.1002/14651858.CD0018.90.pub3) reported that there was no evidence for correction of acidosis by sodium bicarbonate in pre-end-stage renal disease (ESRD) patients, and concluded that randomized controlled trials (RCTs) are necessary to evaluate the benefits and harms of correcting metabolic acidosis in pre-ESRD patients. We wanted to evaluate if the administration of alcaly (mainly sodium bicarbonate) is able to significantly modify renal death and to reduce mortality due to cardiovascular events. ⋯ In conclusion, the Work Group on Conservative Therapy for Chronic Renal Insufficiency proposes this prospective, multicenter, cohort, randomized, controlled study to evaluate the effects of correction of acidosis on the progression of the kidney disease evaluated as renal death in ESRD patients.
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Journal of nephrology · Sep 2011
Multicenter Study Clinical TrialIron isomaltoside 1000: a new intravenous iron for treating iron deficiency in chronic kidney disease.
Patients with chronic kidney disease (CKD) often suffer from iron deficiency anemia necessitating treatment with intravenous iron. This study was designed to assess the safety of iron isomaltoside 1000 (Monofer) in CKD patients. The secondary objective was to assess its effect on iron deficiency anemia. ⋯ Iron isomaltoside 1000 was clinically well tolerated, safe and effective. This new intravenous iron may offer a further valuable choice in treating the anemia of CKD.
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Journal of nephrology · May 2008
Randomized Controlled Trial Multicenter Study Comparative StudySupportive Versus Immunosuppressive Therapy of Progressive IgA nephropathy (STOP) IgAN trial: rationale and study protocol.
The best treatment of IgA nephropathy (IgAN) is currently not well defined. The Supportive Versus Immunosuppressive Therapy of Progressive IgA Nephropathy (STOP IgAN) trial aims to answer if, in IgAN patients, an immunosuppressive treatment is more effective than a supportive treatment. ⋯ In a randomized prospective multicenter study (www.clinicaltrials.gov, NCT00554502), we will treat 148 patients at risk for progressive IgA nephropathy following a 6-month run-in phase, in 2 groups: (group a) supportive treatment: patients with a persistent proteinuria >0.75 g/day will receive a maximized therapy to reduce blood pressure and urinary protein loss using angiotensin-converting enzyme inhibitors and AT1 blockers, statins, dietary counseling for a low-sodium and low-protein diet and education/intervention programs to stop smoking. (group b) immunosuppressive treatment: in addition to the identical treatment of group a, patients will receive treatment with steroids (glomerular filtration rate [GFR] > or =60 ml/min) or steroids plus cyclophosphamide/azathioprine (GFR <60 ml/min). Study end points are the complete remission of the disease and the individual degree of renal functional loss. If the immunosuppressive therapy shows a superior efficacy with respect to prevention of renal failure, the potentially higher therapy cost and risk might be justified. Finally, our trial can serve as a model for various other types of glomerulonephritis, for which such trials are very difficult to perform, given their infrequency.
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Journal of nephrology · Nov 2003
Randomized Controlled Trial Multicenter Study Clinical TrialThe benefit of STent placement and blood pressure and lipid-lowering for the prevention of progression of renal dysfunction caused by Atherosclerotic ostial stenosis of the Renal artery. The STAR-study: rationale and study design.
Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal function and is one of the most important causes of renal failure in the elderly. Current treatment includes restoration of the renal arterial lumen by endovascular stent placement. However, this treatment only affects damage caused by ARAS due to the stenosis and ensuing post-stenotic ischemia. ARAS patients have severe general vascular disease. Atherosclerosis and hypertension can also damage the kidney parenchyma causing renal failure. Medical treatment focuses on the latter. Lipid-lowering drugs (statins) could reduce renal failure progression and could reduce the overall high cardiovascular risk. The additional effect on preserving renal function of stent placement as compared to medical therapy alone is unknown. Therefore, the STAR-study aims to compare the effects of renal artery stent placement together with medication vs. medication alone on renal function in ARAS patients. ⋯ Patients with an ARAS of > or = 50% and renal failure (creatinine (Cr) clearance < 80 mL/min/1.73 m2) are randomly assigned to stent placement with medication or to medication alone. Medication consists of statins, anti-hypertensive drugs and antiplatelet therapy. Patients are followed for 2 yrs with extended follow-up to 5 yrs. The primary outcome of this study is a reduction in Cr clearance > 20% compared to baseline. This trial will include 140 patients.