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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

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.


Condition or disease Intervention/treatment Phase
Kidney Failure Dialysis Procedure: Standard Haemodialysis Procedure: Incremental dialysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Official Title: Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function? A Multicentre Feasibility Randomised Controlled Trial
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : January 2, 2019
Estimated Study Completion Date : March 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
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.
Procedure: Standard Haemodialysis
Thrice weekly dialysis.

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.

Procedure: Incremental dialysis
Individualised dialysis dose according to native kidney function.




Primary Outcome Measures :
  1. Recruitability [ Time Frame: 12 months ]
    Number of patients potentially eligible for screening during the study period

  2. Recruitability [ Time Frame: 12 months ]
    Proportion of screened patients who fulfil study criteria.

  3. Recruitability [ Time Frame: 12 months ]
    Proportion of patients approached who agree to participate in the study.

  4. Retainability [ Time Frame: 12 months ]
    Proportion of patients randomised who withdraw from the study and the reasons for their withdrawal.

  5. Protocol Adherence [ Time Frame: 12 months ]
    Proportion of patients who adhere to protocol dialysis frequency.

  6. 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).

  7. Effect size [ Time Frame: 6 months after randomisation ]
    Rate of change (mean) of RKF in the first 6 months after randomisation.

  8. Dialysis dose [ Time Frame: 6 months after randomisation ]
    Dialysis dose measured by eKT/V

  9. Residual kidney function [ Time Frame: 6 months after randomisation ]
    Residual kidney function measured by eKT/V


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 12 months ]
    Assessed using EQ-5D-5L questionnaire.

  2. Depression [ Time Frame: 12 months ]
    Assessed using PHQ-9 questionnaire.

  3. Illness intrusiveness [ Time Frame: 12 months ]
    Assessed using Illness intrusiveness rating scale.

  4. Changes in cognitive function [ Time Frame: 12 months ]
    Assessed by MOCA tool.

  5. Functional status [ Time Frame: 12 months ]
    Assessed by Clinical Frailty Score (CFS).

  6. Incidence of vascular access failures [Safety] [ Time Frame: 12 months ]
    Frequency of vascular access failures and interventions.

  7. Major Adverse Cardiac Events [ Time Frame: 12 months ]
    Assessed by recording of the frequency of the events.

  8. Survival [ Time Frame: 12 months ]
    Measured by all-cause mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418181


Contacts
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Contact: Dr Enric Vilar 01438 286366 enric.vilar@nhs.net
Contact: Dr Raja M Kaja Kamal 01438284346 rkajakamal@nhs.net

Locations
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United Kingdom
East and North Hertfordshire NHS Trust (incorporating Mount Vernon Cancer Centre) Recruiting
Stevenage, United Kingdom, SG1 4AB
Contact: Dr Enric Vilar         
Sponsors and Collaborators
East and North Hertfordshire NHS Trust
University of Hertfordshire
Investigators
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Principal Investigator: Dr Enric Vilar East and North Hertfordshire NHS Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: East and North Hertfordshire NHS Trust
ClinicalTrials.gov Identifier: NCT03418181    
Other Study ID Numbers: RD2017-21
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by East and North Hertfordshire NHS Trust:
Residual Kidney Function
Haemodialysis
Preserve Residual Kidney Function
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases