Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function?

NCT03418181 | Unknown

• 1 other identifier: RD2017-21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Failure; Dialysis

Keywords

Residual Kidney Function; Haemodialysis; Preserve Residual Kidney Function

Outcome Measures

Primary Outcomes (9)

• Recruitability

  Number of patients potentially eligible for screening during the study period

  12 months

• Recruitability

  Proportion of screened patients who fulfil study criteria.

  12 months

• Recruitability

  Proportion of patients approached who agree to participate in the study.

  12 months

• Retainability

  Proportion of patients randomised who withdraw from the study and the reasons for their withdrawal.

  12 months

• Protocol Adherence

  Proportion of patients who adhere to protocol dialysis frequency.

  12 months

• 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

• Effect size

  Rate of change (mean) of RKF in the first 6 months after randomisation.

  6 months after randomisation

• Dialysis dose

  Dialysis dose measured by eKT/V

  6 months after randomisation

• Residual kidney function

  Residual kidney function measured by eKT/V

  6 months after randomisation

Secondary Outcomes (8)

• Quality of life

  12 months

• Depression

  12 months

• Illness intrusiveness

  12 months

• Changes in cognitive function

  12 months

• Functional status

  12 months

Study Arms (2)

Standard Haemodialysis

OTHER

Thrice weekly dialysis (control arm) - dialysis dose will not be adjusted according to Residual Kidney Function and subjects will be dialysed initially for 3.5-4 hours thrice weekly to ensure a target minimum eKt/V of 1.2.

Procedure: Standard Haemodialysis

Incremental dialysis

EXPERIMENTAL

Twice weekly dialysis - dialysis dose will be adjusted according to Residual Kidney Function. Patients will commence dialysis for 3.5-4 hours twice weekly and have residual renal urea clearance formally measured by interdialytic urine collection at the end of the week following dialysis initiation. Subsequent to this, dialysis dose will be adjusted.

Procedure: Incremental dialysis

Interventions

Standard Haemodialysis PROCEDURE

Thrice weekly dialysis.

Standard Haemodialysis

Incremental dialysis PROCEDURE

Individualised dialysis dose according to native kidney function.

Incremental dialysis

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead
• University of Hertfordshire: collaborator

Study Sites (1)

East and North Hertfordshire NHS Trust (incorporating Mount Vernon Cancer Centre)

Stevenage, SG1 4AB, United Kingdom

RECRUITING

Related Publications (1)

• Kaja Kamal RM, Farrington K, Wellsted D, Sridharan S, Alchi B, Burton J, Davenport A, Vilar E. Impact of incremental versus conventional initiation of haemodialysis on residual kidney function: study protocol for a multicentre feasibility randomised controlled trial. BMJ Open. 2020 Aug 13;10(8):e035919. doi: 10.1136/bmjopen-2019-035919.

  PMID: 32792431 DERIVED

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 Officials

• Dr Enric Vilar

  East and North Hertfordshire NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Enric Vilar

CONTACT

01438 286366; enric.vilar@nhs.net

Dr Raja M Kaja Kamal

CONTACT

01438284346; rkajakamal@nhs.net

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: February 1, 2018
• Study Start: January 8, 2018
• Primary Completion: January 2, 2019
• Study Completion: March 2, 2019
• Last Updated: February 1, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)