Kidney FailureIncrementalHDNCT03418181
Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function?
A study testing Standard Haemodialysis and Incremental dialysis in people with Kidney Failure and Dialysis, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Dialysis
- What is being tested?
- Standard Haemodialysis and Incremental dialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jan 2018to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
East and North Hertfordshire NHS Trust (incorporating Mount Vernon Cancer Centre)
Stevenage, SG1 4AB
About this study
Official title: Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function? A Multicentre Feasibility Randomised Controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Kidney Failure, Dialysis
- Being tested
- Standard Haemodialysis, Incremental dialysis
- Keywords
- Residual Kidney Function, Haemodialysis, Preserve Residual Kidney Function
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard HaemodialysisProcedure or surgery
Thrice weekly dialysis.
Incremental dialysisProcedure or surgery
Individualised dialysis dose according to native kidney function.
| Study group | Role | What they receive |
|---|---|---|
| Standard Haemodialysis | Other | 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. Receives: Procedure: Standard Haemodialysis |
| Incremental dialysis | Experimental | 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. Receives: Procedure: Incremental dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitability
Number of patients potentially eligible for screening during the study period
Measured: 12 months
Recruitability - study criteria met
Proportion of screened patients who fulfil study criteria.
Measured: 12 months
Recruitability - partcipation in the study
Proportion of patients approached who agree to participate in the study.
Measured: 12 months
Retainability
Proportion of patients randomised who withdraw from the study and the reasons for their withdrawal.
Measured: 12 months
Protocol Adherence
Proportion of patients who adhere to protocol dialysis frequency.
Measured: 12 months
Incidence of hospital admissions due to hyperkalemia, fluid overload, lower respiratory tract infection [Safety of the study]
Frequency of hospital admission due to hyperkalemia and fluid overload, and lower respiratory tract infection (LRTI).
Measured: 12 months
Effect size
Rate of change (mean) of RKF in the first 6 months after randomisation.
Measured: 6 months after randomisation
Dialysis dose
Dialysis dose measured by eKT/V
Measured: 6 months after randomisation
Residual kidney function
Residual kidney function measured by eKT/V
Measured: 6 months after randomisation
Secondary outcomes (8)
Quality of life
Assessed using EQ-5D-5L questionnaire.
Measured: 12 months
Depression
Assessed using PHQ-9 questionnaire.
Measured: 12 months
Illness intrusiveness
Assessed using Illness intrusiveness rating scale.
Measured: 12 months
Changes in cognitive function
Assessed by MOCA tool.
Measured: 12 months
Functional status
Assessed by Clinical Frailty Score (CFS).
Measured: 12 months
Incidence of vascular access failures [Safety]
Frequency of vascular access failures and interventions.
Measured: 12 months
Major Adverse Cardiac Events
Assessed by recording of the frequency of the events.
Measured: 12 months
Survival
Measured by all-cause mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start8 Jan 2018
- Primary completion2 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hertfordshire
- Responsible party
- Sponsor
- Investigators
- Dr Enric Vilar, Principal investigator, East and North Hertfordshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418181
- Sponsor's protocol ID
- RD2017-21
- Acronym
- IncrementalHD
- Status last verified
- Jul 2026
- First submitted
- 20 Sep 2017
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
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.
PubMed 32792431
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function? A Multicentre Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03418181
- Acronym / sponsor ID
- IncrementalHD / RD2017-21
- Conditions
- Kidney Failure, Dialysis
- Keywords
- Residual Kidney Function, Haemodialysis, Preserve Residual Kidney Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Collaborators
- University of Hertfordshire
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 2 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Haemodialysis | Other | Procedure: Standard HaemodialysisThrice 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. |
| Incremental dialysis | Experimental | Procedure: Incremental dialysisTwice 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard HaemodialysisThrice weekly dialysis. | Procedure or surgery | Standard Haemodialysis |
| Incremental dialysisIndividualised dialysis dose according to native kidney function. | Procedure or surgery | Incremental dialysis |
Primary outcome
Recruitability
Time frame: 12 months
Number of patients potentially eligible for screening during the study period
Recruitability - study criteria met
Time frame: 12 months
Proportion of screened patients who fulfil study criteria.
Recruitability - partcipation in the study
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
8 secondary outcomes
Quality of life
Time frame: 12 months
Depression
Time frame: 12 months
Illness intrusiveness
Time frame: 12 months
Changes in cognitive function
Time frame: 12 months
Functional status
Time frame: 12 months
Incidence of vascular access failures [Safety]
Time frame: 12 months
Major Adverse Cardiac Events
Time frame: 12 months
Survival
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Derived from this study: PubMed 32792431Kaja 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Enric Vilar principal investigator
East and North Hertfordshire NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Haemodialysis and Incremental dialysis in people with Kidney Failure and Dialysis, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitability (time frame: 12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03418181, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.