Abstract：
:Despite the high costs of treatment of people with kidney disease and associated comorbid conditions, the amount of reliable information available to guide the care of such patients is very limited. Some treatments have been assessed in randomized trials, but most such trials have been too small to detect treatment effects of a magnitude that would be realistic to achieve with a single intervention. Therefore, KDIGO convened an international, multidisciplinary controversies conference titled "Challenges in the Conduct of Clinical Trials in Nephrology" to identify the key barriers to conducting trials in patients with kidney disease. The conference began with plenary talks focusing on the key areas of discussion that included appropriate trial design (covering identification and evaluation of kidney and nonkidney disease outcomes) and sensible trial execution (with particular emphasis on streamlining both design and conduct). Break out group discussions followed in which the key areas of agreement and remaining controversy were identified. Here we summarize the main findings from the conference and set out a range of potential solutions. If followed, these solutions could ensure future trials among people with kidney disease are sufficiently robust to provide reliable answers and are not constrained by inappropriate complexities in design or conduct.
journal_name
Kidney Intjournal_title
Kidney internationalauthors
Baigent C,Herrington WG,Coresh J,Landray MJ,Levin A,Perkovic V,Pfeffer MA,Rossing P,Walsh M,Wanner C,Wheeler DC,Winkelmayer WC,McMurray JJV,KDIGO Controversies Conference on Challenges in the Conduct of Clinical Trials in Nephrdoi
10.1016/j.kint.2017.04.019subject
Has Abstractpub_date
2017-08-01 00:00:00pages
297-305issue
2eissn
0085-2538issn
1523-1755pii
S0085-2538(17)30311-3journal_volume
92pub_type
abstract：:Absorption of amino acids by the necturus proximal tubules was measured under free-flow conditions The coexistence of proximal tubular amino acid influx was determined by infusing saline into tubular lumens by the stopped-flow microperfusion technique. Under free-flow conditions, fractional absorption of individual am...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1038/ki.1978.67
更新日期：1978-06-01 00:00:00
abstract：:Kidney transplant patients receiving phenytoin or phenobarbital may have decreased graft survival. These drugs have been shown to enhance the metabolism of glucocorticoids. We determined the disposition of total and unbound prednisolone in six stable kidney transplant patients receiving prednisone for immunosuppressio...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1038/ki.1984.17
更新日期：1984-01-01 00:00:00
abstract：:Epidermal growth factor receptor (EGFR) is a receptor tyrosine kinase. Its activation results in beneficial or detrimental consequences, depending on the particular setting. Earlier studies in the animal model of acute kidney injury showed that EGFR activation promotes renal tubular cell proliferation. Activation of E...
journal_title：Kidney international
pub_type： 杂志文章,评审
doi：10.1038/ki.2012.435
更新日期：2013-05-01 00:00:00
abstract：:The loss of interstitial capillaries is a feature of several experimental models of renal disease and this contributes to secondary kidney injury. Angiopoietin-1 is a secreted growth factor which binds to Tie-2 present on endothelia to enhance cell survival thereby stabilizing capillary architecture in-vitro. Previous...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1038/ki.2008.179
更新日期：2008-08-01 00:00:00
abstract：BACKGROUND:Patients initiating dialysis after a failed kidney transplant are a subgroup of chronic kidney disease (CKD) patients who have not been characterized. Exposure to immunosuppressive medications differentiates these patients from the general incident end-stage renal disease (ESRD) population. METHODS:Data fro...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1046/j.1523-1755.2002.00373.x
更新日期：2002-06-01 00:00:00
abstract：BACKGROUND:The fluid filling renal cysts in human polycystic kidneys is secreted chiefly by the tubular epithelium lining the cysts via secondary chloride transport. Inhibiting this process by somatostatin therapy should induce shrinking of renal cysts. METHODS:In this randomized, cross-over, placebo-controlled trial ...
journal_title：Kidney international
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1111/j.1523-1755.2005.00395.x
更新日期：2005-07-01 00:00:00
abstract：:Human transitional B cells express relatively high IL-10 and low TNF-α levels, which correlate with B regulatory activity in vitro. Herein, we aim to further define B regulatory phenotype and determine whether B regulatory activity can serve as a prognostic marker for renal allograft dysfunction (graft loss or 2-fold ...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1016/j.kint.2016.08.028
更新日期：2017-01-01 00:00:00
abstract：:The cannabinoid receptor type 2 (CB2) is a G protein-coupled seven transmembrane receptor that transmits endogenous cannabinoid signaling. The role of CB2 in the pathogenesis of kidney injury and fibrosis remains poorly understood. Here we demonstrate that CB2 was induced, predominantly in kidney tubular epithelium, i...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1016/j.kint.2018.05.023
更新日期：2018-10-01 00:00:00
abstract：:Vascular sclerosis has been linked to many risk factors, including smoking, family history, low birth weight, and hypertension. In interesting studies, Goforth et al. show an increased rate of mutations in thrombophilic molecules in patients with vascular sclerosis in renal biopsies, suggesting yet another mechanism. ...
journal_title：Kidney international
pub_type： 评论,杂志文章
doi：10.1038/sj.ki.5001721
更新日期：2006-08-01 00:00:00
abstract：BACKGROUND:Rats that recover from acute puromycin nephrosis later develop widespread glomerular and tubulointerstitial injury. The current study sought to identify structural changes present in the recovery phase that could precipitate progressive renal disease. METHODS:Stereologic studies were performed 10 weeks afte...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1046/j.1523-1755.2002.00481.x
更新日期：2002-08-01 00:00:00
abstract：BACKGROUND:The glomerular endothelial cell is a specialized microvascular cell type involved in the regulation of glomerular ultrafiltration. During gram-negative sepsis, glomerulonephritis, and acute renal failure, bacterial lipopolysaccharide (LPS) and tumor necrosis factor-alpha (TNF-alpha) may cause severe cell dam...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1046/j.1523-1755.1999.00473.x
更新日期：1999-06-01 00:00:00
abstract：:Neutrophil gelatinase-associated lipocalin (Ngal) is a biomarker for acute and chronic renal injuries, including polycystic kidney disease (PKD). However, the effect of Ngal on PKD progression remains unexplored. To study this, we generated 3 strains of mice with different expression levels of Ngal within an establish...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1016/j.kint.2016.09.005
更新日期：2017-02-01 00:00:00
abstract：:Phagocyte-derived interleukin-12 (IL-12) is a key cytokine that induces the development of an effective Th1 type immune response in various inflammatory and infectious disorders. To determine the importance of IL-12 in the pathogenesis of autoimmune renal injury we examined the renal production of this heterodimeric c...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1038/ki.1997.10
更新日期：1997-01-01 00:00:00
abstract：:Serum fibroblast growth factor 23 (FGF23) is a novel phosphaturic factor and important for the regulation of inorganic phosphate (Pi) homeostasis. In this study, we examined an acute effect of oral Pi loading on serum FGF23 levels to clarify the role in rapid adjustment of serum Pi level. We performed a randomized, do...
journal_title：Kidney international
pub_type： 杂志文章,随机对照试验
doi：10.1038/sj.ki.5002000
更新日期：2006-12-01 00:00:00
abstract：BACKGROUND:The purpose of this study was to examine the lipid abnormalities associated with urinary albumin excretion rate (UAER) in type 2 diabetic patients. METHODS:A total of 275 (122 men and 153 women; aged 60.6 +/- 11.1 years) patients were selected with stringent criteria to prevent confounders. Normoalbuminuria...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1111/j.1523-1755.2005.00235.x
更新日期：2005-04-01 00:00:00
abstract：:The Institute of Medicine's recent report, Organ Donation: Opportunities for Action, studies the current problems facing organ donation in the USA, making suggestions for quality improvement and analyzing various proposals of incentivized donation and presumed consent (PC). Although the report deals with the donation ...
journal_title：Kidney international
pub_type： 杂志文章,评审
doi：10.1038/sj.ki.5002143
更新日期：2007-04-01 00:00:00
abstract：:Atypical hemolytic uremic syndrome (aHUS) is a form of thrombotic microangiopathy (TMA) caused by dysregulated complement activation. Clinically, aHUS is effectively treated by an anti-C5 monoclonal antibody (mAb) but whether the disease is mediated by the C5a receptor (C5aR) or C5b-9 pathway, or both, is unknown. Her...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1016/j.kint.2019.01.009
更新日期：2019-07-01 00:00:00
abstract：BACKGROUND:The link between dialysis "vintage" (length of time on dialysis in months to years) and survival has been difficult to define, largely because of selection effects. End-stage renal disease (ESRD) is thought to be a wasting illness, but there are no published reports describing the associations between vintag...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1046/j.1523-1755.2000.00945.x
更新日期：2000-03-01 00:00:00
abstract：BACKGROUND:Primary collapsing glomerulopathy recurs postransplant, raising the possibility of circulating factors implicated in the pathogenesis of the disease. METHODS:To determine the presence of circulating factors in collapsing glomerulopathy patients, we tested serum from those patients in an in vivo assay. Eleve...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1111/j.1523-1755.2004.00715.x
更新日期：2004-07-01 00:00:00
abstract：:Short-term correction of metabolic acidosis in normal and uremic subjects has been shown to decrease protein degradation, but the long-term effects of better correction of acidosis on nutrition in ESRF are unknown. The aim of this study was to assess the possible benefits, in the nutritional state and morbidity, of im...
journal_title：Kidney international
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1038/ki.1997.433
更新日期：1997-10-01 00:00:00
abstract：:We have shown that cisplatin inhibits fatty acid oxidation, and that fibrate treatment ameliorates renal function by preventing the inhibition of fatty acid oxidation and proximal tubule cell death. Urine samples of mice treated with single injection of cisplatin (20 mg/kg body weight) were collected for 3 days and an...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1038/sj.ki.5000433
更新日期：2006-06-01 00:00:00
abstract：:Acute phosphate nephropathy (APhN) is a clinical pathological entity characterized by acute and subsequent chronic renal failure following exposure to oral sodium phosphate (OSP) bowel purgatives. Renal biopsy findings include acute and chronic tubular injury with prominent tubular and interstitial calcium phosphate d...
journal_title：Kidney international
pub_type： 杂志文章,评审
doi：10.1038/ki.2009.308
更新日期：2009-11-01 00:00:00
abstract：:It is well established that nocturnal hypoxemia in sleep apnea causes an inversion of the circadian arterial pressure rhythm and triggers nocturnal hypertension. Since sleep apnea is very frequent in dialysis patients, we hypothesized that nocturnal hypoxemia may be a factor that contributes to alter the 24-hour arter...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1111/j.1523-1755.1998.00853.x
更新日期：1998-04-01 00:00:00
abstract：:Chronic cyclosporine nephrotoxicity is a poorly understood drug side-effect characterized by renal cortical interstitial scarring. To evaluate procollagen mRNA levels as an early factor in the development of this form of renal fibrosis, we measured renal procollagen alpha 1 (I), alpha 1 (III), alpha 1 (IV) and beta-ac...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1038/ki.1991.75
更新日期：1991-04-01 00:00:00
abstract：:Mesangial cells are essential for the structure and function of glomeruli, but the mechanisms underlying these roles are not well understood. Here, we performed a single-cell RNA-sequence (RNA-seq) analysis of mouse mesangial cells using the Fluidigm C1 platform. We found that gene expression in individual mesangial c...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1016/j.kint.2017.01.016
更新日期：2017-08-01 00:00:00
abstract：:The structure of the duodenal mucosa was evaluated in duodenal biopsy samples obtained from patients with moderate renal failure (MRF) and in dialysis patients (HD) in an effort to examine the possibility that changes in duodenal mucosa may contribute to the impaired calcium absorption in renal failure (RF). The effec...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1038/ki.1981.23
更新日期：1981-02-01 00:00:00
abstract：BACKGROUND:Nitric oxide inactivation by superoxide impairs endothelium-dependent vasodilation and plays a role in various forms of hypertension. Almost no data exist regarding hypertension secondary to chronic renal failure. Previous studies have shown that endothelium-related relaxations, secondary to decreased nitric...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1046/j.1523-1755.2002.00166.x
更新日期：2002-02-01 00:00:00
abstract：:31P NMR as a descriptive technique is of interest to nephrologists. Particular contributions of 31P NMR to our understanding of renal function may be enumerated.: "Free" metabolite levels are different from those classically accepted; in particular, ADP and Pi are low with implications for the control of renal metabol...
journal_title：Kidney international
pub_type： 杂志文章,评审
doi：10.1038/ki.1986.15
更新日期：1986-01-01 00:00:00
abstract：BACKGROUND:Chemokine receptor 5 (CCR5) plays an important role in the recruitment of monocytes and T cells in inflammation and experimental studies suggest that CCR5 might be involved in the pathogenesis of IgA nephropathy. A mutation in the CCR5 gene (CCR5 Delta32), leading to a nonfunctional receptor, was recently de...
journal_title：Kidney international
pub_type： 杂志文章
doi：10.1111/j.1523-1755.2005.00057.x
更新日期：2005-01-01 00:00:00
abstract：:Toward an etiological classification of developmental disorders of the kidney and upper urinary tract. There are a large number of developmental disorders and syndromes that affect the kidney and upper urinary tract. These have generally been classified according to morphological criteria established decades ago. Alth...
journal_title：Kidney international
pub_type： 杂志文章,评审
doi：10.1046/j.1523-1755.2002.00086.x
更新日期：2002-01-01 00:00:00
