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Renal FailureENDURENCT04268264

A Feasibility Study to Test the Acceptability, Tolerance and Safety of Incremental Haemodialysis

A study testing Incremental haemodialysis and Conventional haemodialysis in people with Renal Failure and Hemodialysis Complication, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This feasibility study tests if patients find incremental HD acceptable, whether they tolerate the treatment as planned and to evaluate its safety. Over a period of 18-months, 20 participants will be recruited in to the study who are about to start HD therapy for ESRD. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Failure, Hemodialysis Complication, Morality
What is being tested?
Incremental haemodialysis and Conventional haemodialysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited Kingdom
Study dates
1 May 2019to 28 Feb 2022
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
  • patients with CKD-5 who are about to start planned HD
  • At least 3 months of prior specialist renal follow-up at the time of starting HD
  • Able to meet all the study requirements
  • Written signed informed consent.

Who cannot join

  • Age < 18
  • No prior contact with nephrologists for > 3 months
  • Cross-over in to HD from peritoneal dialysis
  • Currently undergoing HD therapy
  • Any condition which in the opinion of the investigator makes the participant unsuitable for entry in to the study
  • Participation in an interventional study in the preceding 6 weeks
Show all 9Show fewer
  • History of myocardial infarction in the preceding 3 months
  • Inability to provide informed consent
  • Inability to comply with the study schedule and follow-up.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Hull University Teaching Hospitals NHS Trust

    Hull, East Yorkshire, HU3 2JZ

Other trials in United Kingdom

About this study

Official title: Effect of Incremental Introduction of Dialysis Versus Standard Care in Patients With End-stage Renal Disease: a Feasibility Study

This feasibility study tests if patients find incremental HD acceptable, whether they tolerate the treatment as planned and to evaluate its safety. Over a period of 18-months, 20 participants will be recruited in to the study who are about to start HD therapy for ESRD. The participants will start HD incrementally (incremental HD group) reaching full dose HD over a period of approximately 15 weeks. The outcomes will be compared to a cohort of 40 matched patients who previously started HD in the conventional manner (historical controls, conventional HD group).

All patients will be followed-up for 6 months after first dialysis. Participants will be reviewed regularly during this time, and will undergo laboratory and bed-site monitoring tests. Acceptability and tolerance will be tested by documenting the numbers and percentages of patients who agree to participate and continue in the study. Patients who decline the invitation to join the study will be given the opportunity to express their reasons for declining to go on incremental HD (they will not play further part in the study). The safety of incremental HD will be tested by comparing the rates of pre-defined safety events in the incremental HD vs. conventional HD groups.

Read more

The impact of incremental HD on patients' residual renal function will be monitored using serial 24-hour urine collections, bio-impedance testing will be conducted to estimate changes in fluid load, measurements of quality-of-life will be undertaken by using patient KDQOL-SF v1.3 questionnaires. These tests will be repeated at regular intervals. Blood tests for estimation of residual renal function and markers of renal anemia, bone disease and cardiac load will be performed at regular intervals and will be compared between the two groups (incremental HD vs. conventional HD groups). These measurements will help in the evaluation of impact of incremental HD on patients' health and well-being. The completion rates of these tests will provide important information about whether they should be included in a future larger trial of incremental HD. Participants undergoing incremental HD will be invited to take part in semi-structured interviews aimed at exploring patients' experiences of receiving incremental HD and their participation in the study.

Data from this study will be used to test if it is feasible to use deaths (or a combination of deaths and cardiovascular events) as the main outcome measure in a future definitive trial on incremental HD. The data should enable a sample-size calculation for a future full-scale trial.

Being tested
Incremental haemodialysis, Conventional haemodialysis
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Incremental haemodialysisProcedure or surgery

    twice weekly haemodilysis at the start, gradually building up to full dose dialysis over a period of 15 weeks

  • Conventional haemodialysisProcedure or surgery

    three times weekly 4-hour long haemodialysis sessions from the start

Study groups in NCT04268264
Study groupRoleWhat they receive
Treatment armExperimentalWill receive trial intervention, Incremental haemodialysis (n=20)
Receives: Procedure: Incremental haemodialysis
Control armOtherHistorical controls. Matched controls from database of historical patients receiving conventional, three times weekly haemodialysis treatment (n=40)
Receives: Procedure: Conventional haemodialysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability: Recruitment rate

    What proportion of eligible patients were recruited in to the trial?

    Measured: 6 months

  2. Tolerance: Retention rate

    What proportion of participants completed treatment as planned

    Measured: 6 months

  3. Completion rates of non-routine tests

    Completion rates of the non-routine tests a) the 24-hour urine collections, b) six-minute walk test, c) bio-impedance testing and d) quality of life questionnaires

    Measured: 6 months

Secondary outcomes (10)

  1. Mortality and cardiovascular event rates

    Differences in mortality, and the composite of mortality and major cardiovascular events, between the interventional and control groups.

    Measured: 6 months

  2. Mechanistic 1: Rate of loss of residual renal function in the interventional group

    Differences in renal urea clearance (in millilitres/min) from baseline

    Measured: 6 months

  3. Mechanistic 2:Changes in fluid load

    Differences in overhydration volume (as measured through bio-impedance testing)

    Measured: 6 months

  4. Mechanistic 3:Quality of life

    Changes in quality of life scores (using KDQOL-SF v 1.3) from baseline

    Measured: 6 months

  5. Mechanistic 4: Anaemia control

    Changes in haemoglobin levels from baseline

    Measured: 6 months

  6. Mechanistic 5: Parathyroid hormone control

    Changes in serum Parathyroid hormone, calcium and phosphate levels from baseline

    Measured: 6 months

  7. Mechanistic 6: Cardiac load

    Changes in serum NT-proBNP measurements from baseline

    Measured: 6 months

  8. Safety 1: pre dialysis hyperkalaemia

    Number of events: pre-dialysis hyperkalaemia (6.5 mmol/l or above)

    Measured: 6 months

  9. Safety 2: severe hypertension

    Number of events: severe pre-dialysis hypertension (systolic BP > 180 and/or diastolic BP > 110 mmHg)

    Measured: 6 months

  10. Safety 3: Inter-dialytic weight gain

    Number of events: interdialytic weight gain of greater than 4 kg

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2020
  2. Study start1 May 2019
  3. Primary completion28 Feb 2022
  4. Study completion28 Feb 2022

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04268264
Sponsor's protocol ID
R2338
Acronym
ENDURE
Status last verified
Apr 2022
First submitted
14 Nov 2019
Last updated
18 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hazara AM, Twiddy M, Allgar V, Bhandari S. Phased Introduction of Haemodialysis in Patients with Kidney Failure: A Mixed-Methods Feasibility Study. Healthcare (Basel). 2026 Mar 20;14(6):792. doi: 10.3390/healthcare14060792.

    PubMed 41897245

Questions about this trial

What is this clinical trial studying?

A study testing Incremental haemodialysis and Conventional haemodialysis in people with Renal Failure and Hemodialysis Complication, run by Hull University Teaching Hospitals 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 5 inclusion and 9 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 18 Apr 2022. 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?

Acceptability: Recruitment rate (time frame: 6 months). The study lists 3 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 NCT04268264, 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 18 Apr 2022.

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