Clinical trial NCT02423655: Routine and Deferred Dialysis Initiation
Official title: A Randomized, Controlled Trial to Evaluate Routine and Deferred Dialysis Initiation in Chinese Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Sichuan Academy of Medical Sciences
name: First Affiliated Hospital of Zhejiang University
name: The First Affiliated Hospital of Zhengzhou University
name: Shaanxi Hospital of Traditional Chinese Medicine
name: Peking Union Medical College Hospital
name: Shengjing Hospital
name: The First Affiliated Hospital of BaoTou Medical College
name: Beijing Hospital, National Center of Gerontology
name: Beijing Haidian Hospital/Beijing Haidian Section of Peking University Third Hospital
name: Beijing Tongren Hospital
name: Xuanwu Hospital, Beijing
name: First Hospital of China Medical University
name: Hangzhou Hospital of Traditional Chinese Medicine
name: Ruijin Hospital
First posted: 2015-04-22
Enrollment: 1049
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy and safety of deferred dialysis initiation in Chinese population. 16 tertiary hospitals across China will be randomly assigned into routine and deferred dialysis groups.

Detailed description: The timing for initiating dialysis for progressive chronic kidney disease (CKD) patients is an important issue yet is not well established. There is a strong trend to early dialysis initiation for end stage renal disease (ESRD) patients over the past decades. However, observational data found that early initiation seemed to produce no benefit but additional burden to patients and the health care system. The IDEAL study, the only randomized, controlled trial (RCT) on this issue, found that all-cause mortality, comorbidities and quality of life had no difference between early (glomerular filtration rate, GFR 10-14ml/min/1.73m2) and late (GFR 5-7ml/min/1.73m2) dialysis starters. However there was a big limitation in this study that the difference for average GFR between two groups (12 ml/min/1.73 m2 vs. 9.8 ml/min/1.73m2) was not so separate. Recently, the Canadian Society of Nephrology have released a clinical practice guideline on this issue. The guideline recommends an "intent-to-defer" approach for dialysis initiation and to initiate dialysis in the absence of symptoms in patients with an estimated GFR of 6 ml/min /1.73 m2 or less. In this guideline the specialists also express that the optimal management of patients with an estimated GFR of 6 ml/min per 1.73 m2 or less is based on limited data. There is a gap in knowledge. This research will further evaluate the efficacy and safety of deferred dialysis initiation and fill in this gap. In this study, algorithms will be adopted to determine the timing of dialysis initiation for both routine and deferred dialiysis groups, and the only difference in these two algorithms is the GFR level to initiate dialysis (7 Vs. \<5 ml/min per 1.73 m2). The theory that blood access (arteriovenous fistulas) can be timely prepared according to the past GFR decline trajectory will also be tested.

Eligibility criteria: Inclusion Criteria:

1. Nondialysis-dependent stable CKD stage 4-5 patients (eGFR\>7ml/min /1.73 m2)
2. Willing to choose dialysis as his renal replacement therapy method
3. Heart function: grade I or II (NYHA Functional Classification)

Exclusion Criteria:

1. The life expectancy of patients is estimated to be short (due to causes other than kidney disease);
2. Acute infection occurred in one month;
3. Myocardial infarction, NYHA class IV or stroke events within 3 months;
4. Uncontrolled malignancy;
5. Active viral hepatitis;
6. Active rheumatic disease;
7. Pregnant women, women intending to conceive after enrollment or breastfeeding woman;
8. Planning to take kidney transplantation within the study period;
9. With indices of emergency dialysis;
10. eGFR less than 7 ml/min/1.73m2 in first visit;
11. Under other clinical studies which has an impact on this study;
12. Unable to provide written informed consent.

Primary outcomes:
measure: All-cause mortality: Proportion of patients who die from any cause
timeFrame: From date of enrollment until the end of study, assessed up to 3 years
measure: Acute nonfatal cerebro-cardiovascular events before dialysis initiation
timeFrame: From date of enrollment until the date of dialysis initiation, or the date of death from any cause,or the end of study, whichever came first, assessed up to 3 year
measure: Acute nonfatal cerebro-cardiovascular events after dialysis initiation
timeFrame: From date of dialysis initiation until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 year
Secondary outcomes:
measure: Hospitalization: Proportion of patients who are admitted to hospital
timeFrame: From date of enrollment until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 year
measure: Nutrition assessment
timeFrame: From date of enrollment until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 years, performed every 3 months
measure: Patient reported outcome of quality of life
timeFrame: From date of enrollment until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 years, once every 3 months
measure: Complications of dialysis
timeFrame: From date of dialysis initiation until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 year
measure: Costs
timeFrame: From date of enrollment until the date of death from any cause,or the end of study, whichever came first, assessed up to 3 years, performed every 3 months
measure: Arteriovenous fistulas usage
timeFrame: From date of enrollment until the date of dialysis initiation, assessed up to 3 years
measure: Catheter usage
timeFrame: From date of enrollment until the date of dialysis initiation, assessed up to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Li Zuo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosansky SJ, Cancarini G, Clark WF, Eggers P, Germaine M, Glassock R, Goldfarb DS, Harris D, Hwang SJ, Imperial EB, Johansen KL, Kalantar-Zadeh K, Moist LM, Rayner B, Steiner R, Zuo L. Dialysis initiation: what's the rush? Semin Dial. 2013 Nov-Dec;26(6):650-7. doi: 10.1111/sdi.12134. Epub 2013 Sep 19.
citation: Cooper BA, Branley P, Bulfone L, Collins JF, Craig JC, Fraenkel MB, Harris A, Johnson DW, Kesselhut J, Li JJ, Luxton G, Pilmore A, Tiller DJ, Harris DC, Pollock CA; IDEAL Study. A randomized, controlled trial of early versus late initiation of dialysis. N Engl J Med. 2010 Aug 12;363(7):609-19. doi: 10.1056/NEJMoa1000552. Epub 2010 Jun 27.
citation: Crews DC, Scialla JJ, Boulware LE, Navaneethan SD, Nally JV Jr, Liu X, Arrigain S, Schold JD, Ephraim PL, Jolly SE, Sozio SM, Michels WM, Miskulin DC, Tangri N, Shafi T, Wu AW, Bandeen-Roche K; DEcIDE Network Patient Outcomes in End Stage Renal Disease Study Investigators. Comparative effectiveness of early versus conventional timing of dialysis initiation in advanced CKD. Am J Kidney Dis. 2014 May;63(5):806-15. doi: 10.1053/j.ajkd.2013.12.010. Epub 2014 Feb 6.
citation: Nesrallah GE, Mustafa RA, Clark WF, Bass A, Barnieh L, Hemmelgarn BR, Klarenbach S, Quinn RR, Hiremath S, Ravani P, Sood MM, Moist LM; Canadian Society of Nephrology. Canadian Society of Nephrology 2014 clinical practice guideline for timing the initiation of chronic dialysis. CMAJ. 2014 Feb 4;186(2):112-7. doi: 10.1503/cmaj.130363. No abstract available.
citation: Zhao X, Wang P, Wang L, Chen X, Huang W, Mao Y, Hu R, Cheng X, Wang C, Wang L, Zhang P, Li D, Wang Y, Ye W, Chen Y, Jia Q, Yan X, Zuo L. Protocol for a prospective, cluster randomized trial to evaluate routine and deferred dialysis initiation (RADDI) in Chinese population. BMC Nephrol. 2019 Dec 9;20(1):455. doi: 10.1186/s12882-019-1627-0.