UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000038028
Receipt No. R000043348
Scientific Title Solute removal of hybrid online hemodiafiltration compared to pre-dilution online hemodiafiltration
Date of disclosure of the study information 2019/09/25
Last modified on 2019/09/18 (Ver. 2)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information
Public title Solute removal of hybrid online hemodiafiltration compared to pre-dilution online hemodiafiltration
Acronym Solute removal of hybrid online hemodiafiltration compared to pre-dilution online hemodiafiltration
Scientific Title Solute removal of hybrid online hemodiafiltration compared to pre-dilution online hemodiafiltration
Scientific Title:Acronym Solute removal of hybrid online hemodiafiltration compared to pre-dilution online hemodiafiltration
Region
Japan

Condition
Condition chronic kidney disease/dialysis patient
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Predilution online hemodiafiltration (OHDF) can safely and effectively remove middle- to high-molecular weight uremic substances close to albumin. However, there is a concern that the removal performance of OHDF may deteriorate over time due to the fouling effect caused by the attachment of proteins to the membrane. In recent years, an automated machine called hybrid OHDF which combines intermittent infusion hemodiafiltration (I-HDF) and OHDF has been developed. Since the addition of I-HDF prevents fouling, the amounts of solutes removed may increase compared to OHDF. However, this has not been clarified. In this study, the solute removal performance of hybrid OHDF was compared to that of predilution OHDF.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ten patients undergoing chronic maintenance dialysis therapy were included in this study. Four blood purification procedures were performed on the first day of each week's dialysis treatment: predilution OHDF using ABH-22LA (albumin leakage suppression type hemodiafilter), predilution OHDF using ABH-22PA (albumin leakage type hemodiafilter), hybrid OHDF using ABH-22LA, and hybrid OHDF using ABH-22PA. The dialyzed and filtered fluid drained during the 4-h session was collected and the concentrations of urea nitrogen, creatinine, inorganic phosphorus, beta2-microglobulin, alfa 1-microglobulin, and albumin were measured. From these, the removed amount and the clear space of each solute were calculated and were compared in hybrid OHDF and predilution OHDF.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Predilution OHDF (ABH-22PA) >> Washout period (2 hemodialysis) >> Hybrid OHDF (ABH-22PA) >> Washout period (2 hemodialysis) >> Predilution OHDF (ABH-22LA) >> Washout Period (2 hemodialysis) >> Hybrid OHDF (ABH-22LA)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria The patients with albumin of 3.5 g/dL or more who have been undergoing chronic maintenance dialysis therapy between March 2019 to April 2019 at the Toujinkai Hospital.
Key exclusion criteria None
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name suzuki
Organization Toujinkai Hospital
Division name Clinical Engineering
Zip code 612-8026
Address 83-1, Iga, Momoyama-cho, Fushimi-ku, Kyoto 612-8026, Japan
TEL 075-622-1991
Email suzuki@tojinkai.jp

Public contact
Name of contact person
1st name Naoki
Middle name
Last name Suzuki
Organization Toujinkai Hospital
Division name Clinical Engineering
Zip code 612-8026
Address 83-1, Iga, Momoyama-cho, Fushimi-ku, Kyoto 612-8026, Japan
TEL 075-622-1991
Homepage URL
Email suzuki@tojinkai.jp

Sponsor
Institute Division of Clinical Engineering, Toujinkai Hospital
Institute
Department

Funding Source
Organization Toujinkai Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Toujinkai Hospital
Address 83-1, Iga, Momoyama-cho, Fushimi-ku, Kyoto 612-8026, Japan
Tel 075-622-1991
Email suzuki@tojinkai.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 09 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 10
Results 
In the treatments that used ABH-22LA, hybrid OHDF removed significantly more and had larger alfa 1-microglobulin clear space than pre-dilution OHDF. In the treatments that used ABH-22PA, hybrid OHDF removed significantly more and had larger beta 2-microglobulin, alfa 1-microglobulin, and albumin clear spaces than predilution OHDF.
Results date posted
2019 Year 09 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 02 Month 01 Day
Date of IRB
2019 Year 02 Month 10 Day
Anticipated trial start date
2019 Year 02 Month 20 Day
Last follow-up date
2019 Year 05 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 09 Month 17 Day
Last modified on
2019 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043348