NCT02423655

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,049

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

5.1 years

First QC Date

April 10, 2015

Last Update Submit

April 11, 2019

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (3)

  • All-cause mortality: Proportion of patients who die from any cause

    Proportion of patients who die from any cause during observation period.

    From date of enrollment until the end of study, assessed up to 3 years

  • Acute nonfatal cerebro-cardiovascular events before dialysis initiation

    Proportion of patients who suffer from acute nonfatal cerebro-cardiovascular events before dialysis initiation. Cerebro-cardiovascular events include acute myocardial infarction,acute coronary ischemia syndrome,acute heart failure, acute exacerbation of chronic heart failure ,severe arrhythmia, stroke, etc.

    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

  • Acute nonfatal cerebro-cardiovascular events after dialysis initiation

    Proportion of patients who suffer from acute nonfatal cerebro-cardiovascular events after dialysis initiation. Cerebro-cardiovascular events include acute myocardial infarction,acute coronary ischemia syndrome,acute heart failure, acute exacerbation of chronic heart failure ,severe arrhythmia, stroke, etc.

    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 (7)

  • Hospitalization: Proportion of patients who are admitted to hospital

    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

  • Nutrition assessment

    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

  • Patient reported outcome of quality of life

    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

  • Complications of dialysis

    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

  • Costs

    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

  • +2 more secondary outcomes

Study Arms (2)

Deffered Dialysis Initiation

EXPERIMENTAL

Algorithm for deferred dialysis intervention: initiating dialysis in the absence of symptoms in patients with an eGFR of 5 ml/min /1.73 m2 or less

Other: Algorithm for deferred dialysis intervention

Routine dialysis Initiation

ACTIVE COMPARATOR

Algorithm for routine dialysis intervention: initiating dialysis in the absence of symptoms in patients with an eGFR of 7 ml/min /1.73 m2 (which is the average GFR for patients in Beijing to start dialysis )

Other: Algorithm for routine dialysis intervention

Interventions

Algorithm for deferred dialysis interventionOTHER

Use combined indications to guide researchers to defer dialyzing progressive CKD patients. Asymptomatic patient will not start dialysis treatment until his eGFR becomes less than 5 ml/min/1.73m2. Or until 1. Patient's Kraemer index is \>6 or with overt fluid overload after trying all conservative means（including appropriate medicines） 2. Patient's Subjective Global Assessment method (SGA) assessment is grade C 3. Patients have indications for emergency dialysis 4. Sever symptoms which cannot be relieved by conservative treatment

Deffered Dialysis Initiation
Algorithm for routine dialysis interventionOTHER

Use combined indications to guide researchers to initiate dialysis in progressive CKD patients routinely. Researchers will start dialysis treatment for a patient when his eGFR reaches 7 ml/min/1.73m2 in asymptomatic patients. Or patients have indications below: 1. Patient's Kraemer index is \>6 or with overt fluid overload after trying all conservative means（including appropriate medicines） 2. Patient's SGA assessment is grade C 3. Patients have indications for emergency dialysis 4. Sever symptoms which cannot be relieved by conservative treatment

Routine dialysis Initiation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (5)

  • 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.

    PMID: 24066675RESULT

  • 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.

    PMID: 20581422RESULT

  • 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.

    PMID: 24508475RESULT

  • 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.

    PMID: 24492525RESULT

  • 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.

    PMID: 31818266DERIVED

Related Links

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Algorithms

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Study Officials

  • Li Zuo

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Nephrology Department

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 22, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2020

Study Completion

December 1, 2020

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

CN(1)