NCT03418181: IncrementalHD

Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function?

Status unknown NA Last updated 1 February 2018

What this trial tests

NA trial testing Standard Haemodialysis in Kidney Failure in 50 participants. Status unknown.

Timeline

8 January 2018

Primary endpoint
2 January 2019

2 March 2019

Quick facts

Lead sponsor	East and North Hertfordshire NHS Trust
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	8 January 2018
Primary completion	2 January 2019
Estimated completion	2 March 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• Standard Haemodialysis
• Incremental dialysis

Conditions studied

• Kidney Failure — all drugs for Kidney Failure →
• Dialysis — all drugs for Dialysis →

Sponsor

East and North Hertfordshire NHS Trust

Who can join

18 and older, any sex, with Kidney Failure or Dialysis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Narrative Review of Incremental Hemodialysis.
   Murea M, Moossavi S, Garneata L, Kalantar-Zadeh K. · · 2020 · cited 38× · PMID 32043027 · DOI 10.1016/j.ekir.2019.11.014
2. Impact of incremental versus conventional initiation of haemodialysis on residual kidney function: study protocol for a multicentre feasibility randomised controlled trial.
   Kaja Kamal RM, Farrington K, Wellsted D, Sridharan S, et al · · 2020 · cited 11× · PMID 32792431 · DOI 10.1136/bmjopen-2019-035919
3. Incremental dialysis: two complementary views.
   Casino DFG, Murea M, Floege MJ, Zoccali C. · · 2024 · cited 7× · PMID 38404364 · DOI 10.1093/ckj/sfae020
4. Incremental versus standard dialysis for people with kidney failure
   Sabanayagam D, Hegerty K, Au E, Beruni N, et al · · 2023