Pentoxifylline in diabetic kidney disease (VA PTXRx): protocol for a pragmatic randomised controlled trial.
Pentoxifylline in diabetic kidney disease (VA PTXRx): protocol for a pragmatic randomised controlled trial.
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糖尿病肾脏疾病（VA PTXRX）中的五氧化氨基林：实用随机对照试验的方案。
DOI：
10.1136/bmjopen-2021-053019
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发表时间：
2021-08-16
期刊：
影响因子：
2.9
通讯作者：
Emanuele NV
中科院分区：
文献类型：
--
作者：
Leehey DJ;Carlson K;Reda DJ;Craig I;Clise C;Conner TA;Agarwal R;Kaufman JS;Anderson RJ;Lammie D;Huminik J;Polzin L;McBurney C;Huang GD;Emanuele NV
糖尿病肾病（DKD）是美国和全球终末期肾病（ESRD）的最常见原因。最近的实验和临床数据表明，非特异性磷酸二酯酶抑制剂己酮可可碱（PTX）可能会减缓慢性肾脏疾病的进展。然而，需要一项大规模的随机临床试验来确定PTX是否可以减少DKD的ESRD和死亡。退伍军人事务部（VA）PTXRx是一项实用、随机、安慰剂对照的多中心VA合作研究，旨在检验以下假设：与常规治疗加安慰剂相比，PTX加常规治疗可缩短2型糖尿病DKD患者至ESRD或死亡的时间。该研究旨在在4年内招募2510名患者，并额外进行长达5年的随访，以产生总共646起主要事件。本研究的主要目的是比较随机分配至PTX组或安慰剂组的受试者至ESRD或死亡（全因死亡率）的时间。次要终点为：（1）健康相关生活质量，（2）至血清肌酐加倍的时间，（3）充血性心力衰竭住院的发生率，（4）三点主要不良心血管事件复合终点的发生率（心血管死亡、非致命性心肌梗死、非致命性中风），（5）外周血管疾病的发病率，（6）从基线到6个月尿白蛋白/肌酐比值的变化和（7）研究期间估计肾小球滤过率（eGFR）的年变化率。本研究已获得VA中央机构审查委员会（cIRB/18-36）的批准，并将按照赫尔辛基宣言和药物临床试验质量管理规范指南进行。Hines合作研究计划将最终确定研究结果，并将根据报告试验的统一标准在同行评审的科学期刊上发表。NCT 03625648。
Diabetic kidney disease (DKD) is the most frequent cause of end-stage renal disease (ESRD) in the USA and worldwide. Recent experimental and clinical data suggest that the non-specific phosphodiesterase inhibitor pentoxifylline (PTX) may decrease progression of chronic kidney disease. However, a large-scale randomised clinical trial is needed to determine whether PTX can reduce ESRD and death in DKD. Veterans Affairs (VA) PTXRx is a pragmatic, randomised, placebo-controlled multicentre VA Cooperative Study to test the hypothesis that PTX, when added to usual care, leads to a reduction in the time to ESRD or death in patients with type 2 diabetes with DKD when compared with usual care plus placebo. The study aims to enrol 2510 patients over a 4-year period with an additional up to 5-year follow-up to generate a total of 646 primary events. The primary objective of this study is to compare the time until ESRD or death (all-cause mortality) between participants randomised to PTX or placebo. Secondary endpoints will be: (1) health-related quality of life, (2) time to doubling of serum creatinine, (3) incidence of hospitalisations for congestive heart failure, (4) incidence of a three-point major adverse cardiovascular events composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke), (5) incidence of peripheral vascular disease, (6) change in urinary albumin-to-creatinine ratio from baseline to 6 months and (7) rate of annual change in estimated glomerular filtration rate (eGFR) during the study period. This study was approved by the VA Central Institutional Review Board (cIRB/18-36) and will be conducted in compliance with the Declaration of Helsinki and the Guidelines for Good Clinical Practice. The Hines Cooperative Studies Programme will finalise the study results, which will be published in accordance with the Consolidated Standards of Reporting Trials statement in a peer-reviewed scientific journal. NCT03625648.
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