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Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function? (IncrementalHD)

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ClinicalTrials.gov Identifier: NCT03418181
Recruitment Status : Unknown
Verified January 2018 by East and North Hertfordshire NHS Trust.
Recruitment status was:  Recruiting
First Posted : February 1, 2018
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
University of Hertfordshire
Information provided by (Responsible Party):
East and North Hertfordshire NHS Trust

Tracking Information
First Submitted Date  ICMJE September 20, 2017
First Posted Date  ICMJE February 1, 2018
Last Update Posted Date February 1, 2018
Actual Study Start Date  ICMJE January 8, 2018
Estimated Primary Completion Date January 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2018)
  • Recruitability [ Time Frame: 12 months ]
    Number of patients potentially eligible for screening during the study period
  • Recruitability [ Time Frame: 12 months ]
    Proportion of screened patients who fulfil study criteria.
  • Recruitability [ Time Frame: 12 months ]
    Proportion of patients approached who agree to participate in the study.
  • Retainability [ Time Frame: 12 months ]
    Proportion of patients randomised who withdraw from the study and the reasons for their withdrawal.
  • Protocol Adherence [ Time Frame: 12 months ]
    Proportion of patients who adhere to protocol dialysis frequency.
  • Incidence of hospital admissions due to hyperkalemia, fluid overload, lower respiratory tract infection [Safety of the study] [ Time Frame: 12 months ]
    Frequency of hospital admission due to hyperkalemia and fluid overload, and lower respiratory tract infection (LRTI).
  • Effect size [ Time Frame: 6 months after randomisation ]
    Rate of change (mean) of RKF in the first 6 months after randomisation.
  • Dialysis dose [ Time Frame: 6 months after randomisation ]
    Dialysis dose measured by eKT/V
  • Residual kidney function [ Time Frame: 6 months after randomisation ]
    Residual kidney function measured by eKT/V
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2018)
  • Quality of life [ Time Frame: 12 months ]
    Assessed using EQ-5D-5L questionnaire.
  • Depression [ Time Frame: 12 months ]
    Assessed using PHQ-9 questionnaire.
  • Illness intrusiveness [ Time Frame: 12 months ]
    Assessed using Illness intrusiveness rating scale.
  • Changes in cognitive function [ Time Frame: 12 months ]
    Assessed by MOCA tool.
  • Functional status [ Time Frame: 12 months ]
    Assessed by Clinical Frailty Score (CFS).
  • Incidence of vascular access failures [Safety] [ Time Frame: 12 months ]
    Frequency of vascular access failures and interventions.
  • Major Adverse Cardiac Events [ Time Frame: 12 months ]
    Assessed by recording of the frequency of the events.
  • Survival [ Time Frame: 12 months ]
    Measured by all-cause mortality
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function?
Official Title  ICMJE Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function? A Multicentre Feasibility Randomised Controlled Trial
Brief Summary

Patients who start haemodialysis usually retain some natural kidney function for months or years after starting dialysis. Even a small amount of this natural kidney function can be helpful in reducing the need for dietary and fluid restriction. There is also good evidence that retaining a small amount of natural kidney function may provide a survival benefit for patients on dialysis.

Most patients who commence haemodialysis start three times per week for 3.5-4 hours per session, irrespective of the amount of natural kidney function they may have. An alternative approach used in some kidney units is to take account of the natural kidney function in prescribing the amount of dialysis. This may allow patients to start treatment needing to spend less time on dialysis or even to start just twice weekly. The amount of dialysis can be adjusted over time as natural kidney function declines. This is called "incremental haemodialysis". Both of these approaches are considered to be standard care although it is not known which approach is more beneficial to patients.

There are some suggestions that the frequency of dialysis may influence the rate of decline of natural kidney function but this need to be tested in a large randomised study. To inform the design of such a study, a smaller scale feasibility study is required.

We intend to randomise fifty new starters on haemodialysis with adequate natural kidney function into two groups - a group who will have dialysis prescribed in the standard fashion - three times weekly for 3.5-4 hours per session or a group who will have an incremental start beginning with twice weekly treatment. We will investigate how many patients have sufficient natural kidney function to be eligible, whether patients are willing to participate and continue in the study, compare the rate of loss of kidney function between groups, and ascertain whether this individualised dialysis approach is less intrusive to patients. The results will be used to design a larger definitive study.

Detailed Description

This study is feasibility randomised controlled trial.

50 patients who have newly started on haemodialysis will be recruited into the study from 4 UK centres.

Eligible patients will be approached prior to initiation of dialysis or after starting dialysis. The details of the study will be explained to them and a Patient Information sheet will be provided. Interested participants will be invited to the study and a written consent will be obtained.

The participants will be randomly allocated to 2 groups.

  1. Thrice weekly dialysis (control arm)
  2. Incremental dialysis - Twice weekly dialysis to start with and slowly increasing the duration and frequency of dialysis to thrice weekly depending on their native kidney function.

All participants will be monitored at least once monthly by performing dialysis related blood tests, urine tests, clinical evaluation, medications, weight, dialysis adequacy, adverse events.

Questionnaire involving quality of life, mood, illness intrusiveness, functional status, cognitive function will also be performed.

Participants will be recruited in the first year and all participants will be followed up for 12 months. All participants may withdraw at any time without any change in their dialysis care.

To ensure independence, the University of Hertfordshire will perform randomisation, and assist with data monitoring and data analysis.

A 6 month rate of loss of native kidney function between the 2 groups will be analysed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The participants will be randomly allocated to 2 groups:

  1. Thrice weekly dialysis (control arm)
  2. Incremental dialysis - Twice weekly dialysis to start with and slowly increasing the duration and frequency of dialysis to thrice weekly depending on their native kidney function.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Kidney Failure
  • Dialysis
Intervention  ICMJE
  • Procedure: Standard Haemodialysis
    Thrice weekly dialysis.
  • Procedure: Incremental dialysis
    Individualised dialysis dose according to native kidney function.
Study Arms  ICMJE
  • Standard Haemodialysis
    Thrice weekly dialysis (control arm) - dialysis dose will not be adjusted according to Residual Kidney Function and subjects will be dialysed initially for 3.5-4 hours thrice weekly to ensure a target minimum eKt/V of 1.2.
    Intervention: Procedure: Standard Haemodialysis
  • Experimental: Incremental dialysis

    Twice weekly dialysis - dialysis dose will be adjusted according to Residual Kidney Function.

    Patients will commence dialysis for 3.5-4 hours twice weekly and have residual renal urea clearance formally measured by interdialytic urine collection at the end of the week following dialysis initiation. Subsequent to this, dialysis dose will be adjusted.

    Intervention: Procedure: Incremental dialysis
Publications * Kaja Kamal RM, Farrington K, Wellsted D, Sridharan S, Alchi B, Burton J, Davenport A, Vilar E. Impact of incremental versus conventional initiation of haemodialysis on residual kidney function: study protocol for a multicentre feasibility randomised controlled trial. BMJ Open. 2020 Aug 13;10(8):e035919. doi: 10.1136/bmjopen-2019-035919.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 25, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2, 2019
Estimated Primary Completion Date January 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years
  • Advanced renal failure due to underlying primary kidney disease and established as a new starter on haemodialysis within the previous 3 months
  • Residual Kidney Function likely to permit twice weekly dialysis as defined by interdialytic urea clearance ≥3ml/min/1.73m2 BSA measured routinely as part of standard care
  • Sufficient understanding of the study procedures and requirements including capacity for explicit agreement to be randomised to standard or incremental HD regimens

Exclusion Criteria:

  • Planned organ transplantation and already on another interventional trial within 3 months from study screening
  • Anticipated requirement for high-volume ultrafiltration on dialysis (e.g. subjects with daily enteral or parenteral nutrition)
  • Blood-borne virus positivity
  • Subjects unable to comply with requirement for monthly interdialytic urine collection.
  • Pregnancy
  • Prognosis <12 months as judged by PI
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03418181
Other Study ID Numbers  ICMJE RD2017-21
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Identifiable personal data will not be published. Study results will be reported to the British Renal Society Conference and published in peer-reviewed journal, presented in conferences (up to 5 years).
Responsible Party East and North Hertfordshire NHS Trust
Study Sponsor  ICMJE East and North Hertfordshire NHS Trust
Collaborators  ICMJE University of Hertfordshire
Investigators  ICMJE
Principal Investigator: Dr Enric Vilar East and North Hertfordshire NHS Trust
PRS Account East and North Hertfordshire NHS Trust
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP