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Chronic Kidney DiseaseHDFITNCT02787161

Impact of HemoDiaFIltration on Physical Activity and Self- Reported Outcomes

A study testing Hemodiafiltration and Hemodialysis in people with Chronic Kidney Disease, run by Pontifícia Universidade Católica do Paraná at 13 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized controlled clinical trial that will analyze the impact of high volume online HDF in comparison to high-flux HD on measured physical activity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease
What is being tested?
Hemodiafiltration and Hemodialysis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
13 sitesBrazil
Study dates
Aug 2016to Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients treated three times per week with HD for at least 3 months and up to 24 months;
  • Clinically stable according to the evaluation of the investigator;
  • Kt/V of > 1.2;
  • Patients with an arteriovenous fistula/graft and permanent catheters with adequate flow.

Who cannot join

  • Age below 18 years;
  • Life expectancy less than 3 months because of nonrenal disease;
  • Participation in another clinical intervention trial;
  • Severe non-compliance regarding frequency and duration of dialysis treatment;
  • Patients with severe limitation to mobility (amputated, neurologic and muscular disorders) will be excluded from the study.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Brazil13 sites

  • Instituto Médico Nefrológico

    Belo Horizonte, Minas Gerais

  • Nefron Contagem

    Contagem, Minas Gerais

  • Irmandade da Santa Casa de Misericórdia de Curitiba

    Curitiba, Paraná

  • Fundação Pro Rim

    Joinville, Santa Catarina

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Hospital São Lucas PUCRS

    Porto Alegre, Rio Grande do Sul

  • Clínica de Diálise Ingá

    Rio de Janeiro

  • Clínica de Doenças Renais - São Lourenço

    Rio de Janeiro

  • Clínica de Doenças Renais - Un. Botafogo

    Rio de Janeiro

  • CETENE

    São Paulo

  • Hospital Alemão Oswaldo Cruz

    São Paulo

  • Hospital do Rim e Universidade Federal de São Paulo

    São Paulo

  • Instituto de Nefrologia de Taubaté

    Taubaté, São Paulo

Other trials in Brazil

About this study

Official title: Impact of HemoDiaFIltration on Physical Activity and Self-reported Outcomes: a Randomized Controlled Trial (HD-FIT Trial)

This is a randomized controlled clinical trial that will analyze the impact of high volume online HDF in comparison to high-flux HD on measured physical activity.

Read the detailed description

HD-FIT is a randomized controlled clinical trial that will analyze the impact of high volume online HDF in comparison to high-flux HD on measured physical activity (number of steps measured in the dialysis day) as a primary endpoint. The analysis of additional accelerometer data, HRQOL and time to recover from a dialysis session will be used as other outcomes. The study will also capture safety data, based on intradialytic events, hospitalization and mortality. Biochemical (according to the local requirements) and drug prescription data will be monitored for pharma-economic analysis. Serum samples will be collected for future analysis of additional biomarkers.

In summary, patients will go through a 4 week run in period on high flux HD. After this, patients will be randomized to the intervention of high volume online HDF for 6 months, or will continue on high flux HD; both groups will be observed for a 12 month follow up period. Patients will be evaluated for physical activity, HRQOL, laboratories and other measures at the baseline, 3 month, and 6 month time points. Evaluation will be repeated in 3 and 6-months. HRQOL, laboratories, and other outcomes will be tracked over the post-interventional follow up period that lasts 12 months after randomization.

Data will be analyzed according to an intention-to-treat principle (i.e., according to assigned instead of received treatment). With an enrollment target of 110 participants in each arm (considering a drop out of 20%) we estimate the 86 patients will complete the follow up in each arm, what will provide the trial a 90% power to detect a 20% effect with respect to the primary outcome (predefined as a 20% increase in average total steps at the dialysis day in the HDF group compared to the HD group). Because of the nature of the intervention, it will not possible to blind the patients, the local study nurses, or the investigators for the treatment assignment.

Fourteen dialysis centers will be invited to participate. Each participating center will receive two 5008S machines and Cordiax dialyzers to be used in the study of 10 patients in each center. Additional patients can be randomized per center with approval of the steering committee. Centralized randomization will based on a 1:1 protocol, stratified by participating center.

Being tested
Hemodiafiltration, Hemodialysis
Keywords
Chronic Kidney Disease, Hemodialysis, Hemodiafiltration, Renal Replacement Therapy, Physical Activity, Accelerometer
Medical subject headings
Renal Insufficiency, Chronic, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HemodiafiltrationDevice

    Also called High volume online HDF

    High volume online HDF

  • HemodialysisDevice

    Also called High-flux HD

    High-flux HD

Study groups in NCT02787161
Study groupRoleWhat they receive
HemodialysisActive comparatorPatients who are treated with high flux hemodialysis will continue the same treatment with high flux hemodialysis.
Receives: Device: Hemodialysis
HemodiafiltrationExperimentalPatients who are treated with high flux hemodialysis will be switched to hemodiafiltration for 6 months.
Receives: Device: Hemodiafiltration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The difference in the change in step counts per 24 hours on dialysis days from baseline to the 6-month follow up in patients treated with high volume online HDF versus high-flux HD

    To capture activity in the study, we will use the Actigraph ™ device to measure acceleration and count steps during 7 days at baseline, 3 and 6 months evaluations, according to a previously described protocol for dialysis patients. A 4s step filter is an intrinsic property of the Actigraph ™ that screens out erroneous steps that might result as from shuffling, standing up, sitting up, sitting down, and vibrations from a moving vehicle. The Actigraph ™ is lightweight (19g), clips at the waist, and provides feedback with on-instrument digital display of step counts. It interfaces with the internet via bluetooth, allowing upload of date and time stamped step counts.

    Measured: Baseline, 3 months and 6 months

  2. The difference in the change in minutes of moderate-to-vigorous physical activity (MVPA) per 24 hours on dialysis days from baseline to the 6-month follow up in patients treated with high volume online HDF versus high-flux HD

    Measured: Baseline, 3 months and 6 months

Secondary outcomes (5)

  1. The difference in the change in self-reported dialysis recovery time from baseline to the 6-month follow up in patients treated with high volume online HDF versus high-flux HD

    Dialysis recovery time will be assessed at baseline and at 3 and 6 months of follow-up in both arms. The dialysis recovery time survey asks the question, " How long does it take to recover from a dialysis session?" . This test has been validated in HD studies, and it is interpreted easily, is easy to respond to, shows stability over time by test-retest, shows both convergent and divergent validity, and is sensitive to change.

    Measured: Baseline, 3 months and 6 months

  2. The difference in the change in SF-36 scores from baseline to the 6-month follow up in patients treated with high volume online HDF versus high-flux HD

    HRQOL will be assessed at baseline and at 3 and 6 months of follow- up with the Kidney Disease Quality of Life - Short Form (KDQOL-SF), adapted and validated to Brazilian Portuguese. This questionnaire covers different domains to face the multidimensional nature of HRQOL. The eight domains of the SF-36 can be summarized in two summary scores, one for physical functioning (the physical composite score [ PCS]) and one for mental functioning (the mental composite score [MCS]). Questionnaires will be applied at the baseline, and 3 and 6 months in both arms. Analysis will include PCS and MCS.

    Measured: Baseline, 3 months and 6 months

  3. Pharmacoeconomy (drug use, hospitalization)

    Income, social status, prescription of drugs, hospitalization

    Measured: Baseline, 3 months and 6 months

  4. Intradialytic events

    Events

    Measured: Baseline, 3 months and 6 months

  5. Mortality

    Survival

    Measured: Baseline, 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionApr 2018
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02787161
Sponsor's protocol ID
PUCPR02
Acronym
HDFIT
Status last verified
Sep 2019
First submitted
20 Apr 2016
Last updated
16 Sep 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Lima JD, Guedes M, Rodrigues SD, Florido ACS, Moreno-Amaral AN, Barra AB, Canziani ME, Cuvello-Neto A, Poli-de-Figueiredo CE, Pecoits-Filho R, Nakao LS. High-volume hemodiafiltration decreases the pre-dialysis concentrations of indoxyl sulfate and p-cresyl sulfate compared to hemodialysis: a post-hoc analysis from the HDFit randomized controlled trial. J Nephrol. 2022 Jun;35(5):1449-1456. doi: 10.1007/s40620-022-01283-3. Epub 2022 Mar 3.

    PubMed 35239175

  • Guedes M, Dambiski AC, Canhada S, Barra ABL, Poli-de-Figueiredo CE, Cuvello Neto AL, Canziani MEF, Strogoff-de-Matos JP, Raimann JG, Larkin J, Canaud B, Pecoits-Filho R; HDFIT Study Investigators. Achieving high convective volume in hemodiafiltration: Lessons learned after successful implementation in the HDFit trial. Hemodial Int. 2021 Jan;25(1):50-59. doi: 10.1111/hdi.12891. Epub 2020 Oct 15.

    PubMed 33058473

  • Larkin JW, Han M, Han H, Guedes MH, Goncalves PB, Poli-de-Figueiredo CE, Cuvello-Neto AL, Barra ABL, de Moraes TP, Usvyat LA, Kotanko P, Canziani MEF, Raimann JG, Pecoits-Filho R; HDFIT Study Investigators. Impact of hemodialysis and post-dialysis period on granular activity levels. BMC Nephrol. 2020 May 25;21(1):197. doi: 10.1186/s12882-020-01853-2.

    PubMed 32450793

  • Pecoits-Filho R, Larkin JW, Poli-de-Figueiredo CE, Cuvello Neto AL, Barra AB, Canhada S, de Campos LG, Woehl J, Goncalves PB, Han H, de Moraes TP, Raimann JG, Canziani MEF; HDFIT Study Investigators. Design and methodology of the impact of HemoDiaFIlTration on physical activity and self-reported outcomes: a randomized controlled trial (HDFIT trial) in Brazil. BMC Nephrol. 2019 Mar 20;20(1):98. doi: 10.1186/s12882-019-1247-8.

    PubMed 30894141

Questions about this trial

What is this clinical trial studying?

A study testing Hemodiafiltration and Hemodialysis in people with Chronic Kidney Disease, run by Pontifícia Universidade Católica do Paraná at 13 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference in the change in step counts per 24 hours on dialysis days from baseline to the 6-month follow up in patients treated with high volume online HDF versus high-flux HD (time frame: Baseline, 3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02787161, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.

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