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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268264
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hull University Teaching Hospitals NHS Trust

Brief 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, 40 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 12 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.

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 and functional status will be undertaken by using patient questionnaires and conducting six-minute walk tests respectively. 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.

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.


Condition or disease Intervention/treatment Phase
Renal Failure Hemodialysis Complication Morality Procedure: Incremental haemodialysis Procedure: Conventional haemodialysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Incremental Introduction of Dialysis Versus Standard Care in Patients With End-stage Renal Disease: a Feasibility Study
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Treatment arm
Will receive trial intervention, Incremental haemodialysis (n=40)
Procedure: Incremental haemodialysis
twice weekly haemodilysis at the start, gradually building up to full dose dialysis over a period of 15 weeks

Control arm
Historical controls. Matched controls from database of historical patients receiving conventional, three times weekly haemodialysis treatment (n=40)
Procedure: Conventional haemodialysis
three times weekly 4-hour long haemodialysis sessions from the start




Primary Outcome Measures :
  1. Acceptability: Recruitment rate [ Time Frame: 6 months ]
    What proportion of eligible patients were recruited in to the trial?

  2. Tolerance: Retention rate [ Time Frame: 6 months ]
    What proportion of participants completed treatment as planned

  3. Completion rates of non-routine tests [ Time Frame: 6 months ]
    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

  4. Safety 1: pre dialysis hyperkalaemia [ Time Frame: 6 months ]
    Number of events: pre-dialysis hyperkalaemia (6.5 mmol/l or above)

  5. Safety 2: severe hypertension [ Time Frame: 6 months ]
    Number of events: severe pre-dialysis hypertension (systolic BP > 180 and/or diastolic BP > 110 mmHg)

  6. Safety 3: Inter-dialytic weight gain [ Time Frame: 6 months ]
    Number of events: interdialytic weight gain of greater than 4 kg


Secondary Outcome Measures :
  1. Mortality and cardiovascular event rates [ Time Frame: 6 months ]
    Differences in mortality, and the composite of mortality and major cardiovascular events, between the interventional and control groups.

  2. Mechanistic 1: Rate of loss of residual renal function in the interventional group [ Time Frame: 6 months ]
    Differences in renal urea clearance (in millilitres/min) from baseline

  3. Mechanistic 2:Changes in fluid load [ Time Frame: 6 months ]
    Differences in overhydration volume (as measured through bio-impedance testing)

  4. Mechanistic 3:Quality of life [ Time Frame: 6 months ]
    Changes in quality of life scores (using KDQOL-SF 36) from baseline

  5. Mechanistic 4: six-minute walk distance [ Time Frame: 6 months ]
    Changes in six-minute walk distance compared to baseline

  6. Mechanistic 5: Anaemia control [ Time Frame: 6 months ]
    Changes in haemoglobin levels from baseline

  7. Mechanistic 6: Parathyroid hormone control [ Time Frame: 6 months ]
    Changes in serum Parathyroid hormone, calcium and phosphate levels from baseline

  8. Mechanistic 7: Cardiac load [ Time Frame: 6 months ]
    Changes in serum NT-proBNP measurements from baseline



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
  • 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.

Exclusion Criteria:

  • 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
  • History of myocardial infarction in the preceding 3 months
  • Inability to provide informed consent
  • Inability to comply with the study schedule and follow-up.

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): NCT04268264


Contacts
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Contact: Adil Hazara, MSc. 00441482604260 adilhazara@nhs.net
Contact: Sunil Bhandari, PhD sunil.bhandari@hey.nhs.uk

Locations
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United Kingdom
Hull University Teaching Hospitals NHS Trust Recruiting
Hull, East Yorkshire, United Kingdom, HU3 2JZ
Contact: Adil Hazara, MSc.    00441482605260    adilhazara@nhs.net   
Principal Investigator: Adil M Hazara, MSc.         
Principal Investigator: Sunil Bhandari, PhD         
Sponsors and Collaborators
Hull University Teaching Hospitals NHS Trust

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Responsible Party: Hull University Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04268264    
Other Study ID Numbers: R2338
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases