Impact of HemoDiaFIltration on Physical Activity and Self- Reported Outcomes

NCT ID: NCT02787161

Last Updated: 2019-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-09-30

Brief 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.

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemodialysis

Patients who are treated with high flux hemodialysis will continue the same treatment with high flux hemodialysis.

Group Type: ACTIVE_COMPARATOR

Hemodialysis

Intervention Type: DEVICE

High-flux HD

Hemodiafiltration

Patients who are treated with high flux hemodialysis will be switched to hemodiafiltration for 6 months.

Group Type: EXPERIMENTAL

Hemodiafiltration

Intervention Type: DEVICE

High volume online HDF

Interventions

Hemodiafiltration

High volume online HDF

Intervention Type: DEVICE

Hemodialysis

High-flux HD

Intervention Type: DEVICE

Other Intervention Names

High volume online HDF; High-flux HD

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius AG

INDUSTRY

Sponsor Role: collaborator

Pontifícia Universidade Católica do Paraná

OTHER

Sponsor Role: lead

Responsible Party

Roberto Pecoits-Filho

MD, PhD, FASN, FACP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Flávio Pecoits-Filho, PI

Role: STUDY_CHAIR

PUC-PR

Locations

Instituto Médico Nefrológico

Belo Horizonte, Minas Gerais, Brazil

Nefron Contagem

Contagem, Minas Gerais, Brazil

Irmandade da Santa Casa de Misericórdia de Curitiba

Curitiba, Paraná, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital São Lucas PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pro Rim

Joinville, Santa Catarina, Brazil

Instituto de Nefrologia de Taubaté

Taubaté, São Paulo, Brazil

Clínica de Diálise Ingá

Rio de Janeiro, , Brazil

Clínica de Doenças Renais - São Lourenço

Rio de Janeiro, , Brazil

Clínica de Doenças Renais - Un. Botafogo

Rio de Janeiro, , Brazil

CETENE

São Paulo, , Brazil

Hospital Alemão Oswaldo Cruz

São Paulo, , Brazil

Hospital do Rim e Universidade Federal de São Paulo

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 35239175 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33058473 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32450793 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30894141 (View on PubMed)

Other Identifiers

PUCPR02

Identifier Type: -

Identifier Source: org_study_id