Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function?

Kidney Failure Clinical Trial

— IncrementalHD  

Official title:

Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function? A Multicentre Feasibility Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03418181
• Other study ID #: RD2017-21
• Status: Recruiting
• Phase: N/A
• First received: September 20, 2017
• Last updated: January 25, 2018
• Start date: January 8, 2018
• Est. completion date: March 2, 2019

Study information

• Verified date: January 2018
• Source: East and North Hertfordshire NHS Trust
• Contact: Dr Enric Vilar
• Phone: 01438 286366
• Email: enric.vilar[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

This study is feasibility randomised controlled trial.

50 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2, 2019
• Est. primary completion date: January 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dialysis
• Kidney Failure
• Renal Insufficiency

Intervention

Procedure:
• Standard Haemodialysis
Thrice weekly dialysis.
• Incremental dialysis
Individualised dialysis dose according to native kidney function.

Locations

Country	Name	City	State
United Kingdom	East and North Hertfordshire NHS Trust (incorporating Mount Vernon Cancer Centre)	Stevenage

Sponsors (2)

Lead Sponsor	Collaborator
East and North Hertfordshire NHS Trust	University of Hertfordshire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitability	Number of patients potentially eligible for screening during the study period	12 months
Primary	Recruitability	Proportion of screened patients who fulfil study criteria.	12 months
Primary	Recruitability	Proportion of patients approached who agree to participate in the study.	12 months
Primary	Retainability	Proportion of patients randomised who withdraw from the study and the reasons for their withdrawal.	12 months
Primary	Protocol Adherence	Proportion of patients who adhere to protocol dialysis frequency.	12 months
Primary	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).	12 months
Primary	Effect size	Rate of change (mean) of RKF in the first 6 months after randomisation.	6 months after randomisation
Primary	Dialysis dose	Dialysis dose measured by eKT/V	6 months after randomisation
Primary	Residual kidney function	Residual kidney function measured by eKT/V	6 months after randomisation
Secondary	Quality of life	Assessed using EQ-5D-5L questionnaire.	12 months
Secondary	Depression	Assessed using PHQ-9 questionnaire.	12 months
Secondary	Illness intrusiveness	Assessed using Illness intrusiveness rating scale.	12 months
Secondary	Changes in cognitive function	Assessed by MOCA tool.	12 months
Secondary	Functional status	Assessed by Clinical Frailty Score (CFS).	12 months
Secondary	Incidence of vascular access failures [Safety]	Frequency of vascular access failures and interventions.	12 months
Secondary	Major Adverse Cardiac Events	Assessed by recording of the frequency of the events.	12 months
Secondary	Survival	Measured by all-cause mortality	12 months