Skip to main content
OpenTrials
Completed

NCT Number: NCT03418181

Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function?

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Failure Dialysis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East and North Hertfordshire NHS Trust (incorporating Mount Vernon Cancer Centre)

Stevenage, SG1 4AB, United Kingdom

About this study

This study is feasibility randomised controlled trial.

54 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.

  • Thrice weekly dialysis (control arm)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Haemodialysis

Procedure

Thrice weekly dialysis.

Incremental dialysis

Procedure

Individualised dialysis dose according to native kidney function.

Primary outcomes

  1. Recruitability

    Time frame: 12 months

    Number of patients potentially eligible for screening during the study period

  2. Recruitability - study criteria met

    Time frame: 12 months

    Proportion of screened patients who fulfil study criteria.

  3. Recruitability - partcipation in the study

    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 outcomes

  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

Sponsors and collaborators

Lead sponsor

East and North Hertfordshire NHS Trust

Other Gov

Collaborators

  • University of Hertfordshire

Registry information

Official study title

Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function? A Multicentre Feasibility Randomised Controlled Trial

Acronym: IncrementalHD

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 1, 2018
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.