Protocol for a prospective, cluster randomized trial to evaluate routine and deferred dialysis initiation (RADDI) in Chinese population.,BMC Nephrology

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Protocol for a prospective, cluster randomized trial to evaluate routine and deferred dialysis initiation (RADDI) in Chinese population.
BMC Nephrology ( IF 2.3 ) Pub Date : 2019-12-09 , DOI: 10.1186/s12882-019-1627-0
Xinju Zhao ₁ , Pei Wang ₂ , Lining Wang ₃ , Xiaonong Chen ₄ , Wen Huang ₅ , Yonghui Mao ₆ , Rihong Hu ₇ , Xiaohong Cheng ₈ , Caili Wang ₉ , Li Wang ₁₀ , Ping Zhang ₁₁ , Detian Li ₁₂ , Yuzhu Wang ₁₃ , Wenling Ye ₁₄ , Yuqing Chen ₁₅ , Qiang Jia ₁₆ , Xiaoyan Yan ₁₇ , Li Zuo ₁

Affiliation

Department of Nephrology, Peking University People's Hospital, Beijing, China.
Department of Nephrology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Department of Nephrology, The First Affiliated Hospital of China Medical University, Shenyang, China.
Department of Nephrology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, China.
Department of Nephrology, Beijing Tongren Hospital Capital Medical University, Beijing, China.
Department of Nephrology, Beijing Hospital, National Center of Gerontology, Beijing, China.
Department of Nephrology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, China.
Department of Nephrology, Shaanxi Hospital of Traditional Chinese Medicine, Shaanxi, China.
Department of Nephrology, The First Affiliated Hospital of Baotou Medical College, Baotou, China.
Department of Nephrology, Sichuan Academy of Medical Sciences, Chengdu, China.
Kidney disease center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
Department of Nephrology, Shengjing Hospital of China Medical University, Shenyang, China.
Department of Nephrology, Beijing Haidian Hospital (Beijing Haidian Section of Peking University Third Hospital), Beijing, China.
Department of Nephrology, Peking Union Medical College Hospital, Beijing, China.
Renal Division, Peking University First Hospital, Beijing, China.
Department of Nephrology, Xuanwu Hospital Capital Medical University, Beijing, China.
Peking University Clinical Research Institute, Beijing, China.

BACKGROUND The timing of when to initiate dialysis for progressive chronic kidney disease (CKD) patients has not been well established. There has been a strong trend for early dialysis initiation for these patients over the past decades. However, the perceived survival advantage of early dialysis has been questioned by a series of recent observational studies. The only randomized controlled trial (RCT) research on this issue found the all-cause mortality, comorbidities, and quality of life showed no difference between early and late dialysis starters. To better understand optimal timing for dialysis initiation, our research will evaluate the efficacy and safety of deferred dialysis initiation in a large Chinese population. METHODS The trial adopts a multicenter, cluster randomized, single-blind (outcomes assessor), and endpoint-driven design. Eligible participants are 18-80 years old, in stable CKD stages 4-5 (eGFR > 7 ml/min /1.73 m2), and with good heart function (NYHA grade I or II). Participants will be randomized into a routine or deferred dialysis group. The reference eGFR at initiating dialysis for asymptomatic patients is 7 ml/min /1.73 m2 (routine dialysis group) and 5 ml/min/1.73 m2 or less (deferred dialysis group) in each group. The primary endpoint will be the difference of all-cause mortality and acute nonfatal cerebro-cardiovascular events between the two groups. The secondary outcomes include hospitalization rate and other safety indices. The primary and secondary outcomes will be analyzed by appropriate statistical methods. DISCUSSION This study protocol represents a large, cluster randomized study evaluating deferred and routine dialysis intervention for an advanced CKD population. The reference eGFR to initiate dialysis for both treatment groups is targeted at less than 7 ml/min/1.73m2. With this design, we aim to eliminate lead-time and survivor bias and avoid selection bias and confounding factors. We acknowledge that the study has limitations. Even so, given the low-targeted eGFR values of both arms, this study still has potential economic, health, and scientific implications. This research is unique in that such a low targeted eGFR value has never been studied in a clinical trial. TRIAL REGISTRATION The trial has been approved by ClinicalTrials.gov (Trial registration ID NCT02423655). The date of registration was April 22, 2015.

更新日期：2019-12-09

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