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

NCT04268264 | Completed DMC

• 1 other identifier: R2338
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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, 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. 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.

Conditions

Renal Failure; Hemodialysis Complication; Morality

Outcome Measures

Primary Outcomes (3)

• Acceptability: Recruitment rate

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

  6 months

• Tolerance: Retention rate

  What proportion of participants completed treatment as planned

  6 months

• 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

  6 months

Secondary Outcomes (10)

• Mortality and cardiovascular event rates

  6 months

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

  6 months

• Mechanistic 2:Changes in fluid load

  6 months

• Mechanistic 3:Quality of life

  6 months

• Mechanistic 4: Anaemia control

  6 months

Study Arms (2)

Treatment arm

EXPERIMENTAL

Will receive trial intervention, Incremental haemodialysis (n=20)

Procedure: Incremental haemodialysis

Control arm

OTHER

Historical controls. Matched controls from database of historical patients receiving conventional, three times weekly haemodialysis treatment (n=40)

Procedure: Conventional haemodialysis

Interventions

Incremental haemodialysis PROCEDURE

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

Treatment arm

Conventional haemodialysis PROCEDURE

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

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Hull University Teaching Hospitals NHS Trust

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: February 13, 2020
• Study Start: May 1, 2019
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

GB (1)