Routine and Deferred Dialysis Initiation (RADDI)

April 11, 2019 updated by: Li Zuo, Peking University People's Hospital

A Randomized, Controlled Trial to Evaluate Routine and Deferred Dialysis Initiation in Chinese Population

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1049

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deffered Dialysis Initiation

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
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
Active Comparator: Routine dialysis Initiation

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality: Proportion of patients who die from any cause
Time Frame: From date of enrollment until the end of study, assessed up to 3 years
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
Time Frame: 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

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
Time Frame: 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

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization: Proportion of patients who are admitted to hospital
Time Frame: 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
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
Time Frame: 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
SGA assessment and serum albumin level are used to assess nutrition status
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
Time Frame: 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
The short form health survey questionnaire 36 will be used.
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
Time Frame: 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
Proportion of patients who suffer from dialysis complications including blood acess infection, thrombosis, hypotension, 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
Costs
Time Frame: 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
All money patients and insurance agency spend on medical care related with CKD
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
Arteriovenous fistulas usage
Time Frame: From date of enrollment until the date of dialysis initiation, assessed up to 3 years
Proportion of patients using arteriovenous fistulas as their blood access when dialysis initiation. The timing for preparing arteriovenous fistulas depends on the past GFR decline trajectory
From date of enrollment until the date of dialysis initiation, assessed up to 3 years
Catheter usage
Time Frame: From date of enrollment until the date of dialysis initiation, assessed up to 3 years
Proportion of patients using catheter as their blood access when dialysis initiation.
From date of enrollment until the date of dialysis initiation, assessed up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

Peking University First Hospital
Peking Union Medical College Hospital
Shengjing Hospital
Xuanwu Hospital, Beijing
First Affiliated Hospital of Zhejiang University
Beijing Tongren Hospital
The First Affiliated Hospital of Zhengzhou University
First Hospital of China Medical University
Sichuan Academy of Medical Sciences
Shaanxi Hospital of Traditional Chinese Medicine
The First Affiliated Hospital of BaoTou Medical College
Hangzhou Hospital of Traditional Chinese Medicine
Beijing Hospital, National Center of Gerontology
Beijing Haidian Hospital/Beijing Haidian Section of Peking University Third Hospital
Ruijin Hospital Affiliated to Shanghai Jiao Tong University

Investigators

  • Principal Investigator: Li Zuo, Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 10, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201502010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Disease

Clinical Trials on Algorithm for deferred dialysis intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe