UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044051 |
|---|---|
| Receipt number | R000050256 |
| Scientific Title | Multicenter, prospective, non-randomized, open-label, single-group study investigating the safety and utility of intradialytic parenteral nutrition using infusion liquid not for renal failure in patients with malnutrition on maintenance hemodialysis |
| Date of disclosure of the study information | 2021/05/09 |
| Last modified on | 2022/10/31 08:28:30 |
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Basic information
Public title
Safety and utility of intradialytic parenteral nutrition using infusion liquid not for renal failure in patients with malnutrition on maintenance hemodialysis
Acronym
IDPN study
Scientific Title
Multicenter, prospective, non-randomized, open-label, single-group study investigating the safety and utility of intradialytic parenteral nutrition using infusion liquid not for renal failure in patients with malnutrition on maintenance hemodialysis
Scientific Title:Acronym
IDPN study
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and utility of intradialytic parenteral nutrition using infusion liquid not for renal failure in maintenance hemodialysis patients with malnutrition
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in serum transthyretin levels before and 12 weeks after the start of intradialytic parenteral nutrition
Key secondary outcomes
Utility outcomes
1) Changes in nutritional parameters (e.g., serum albumin and normalized protein catabolism rate [nPCR]) before and 12 weeks after the start of intradialytic parenteral nutrition (IDPN)
2) Changes in nutritional parameters (e.g., body mass index [BMI], geriatric nutritional risk index [GNRI], survival index [SI], and nutritional risk index for Japanese hemodialysis patients [NRI-JH]) before and 12 weeks after the start of IDPN
3) Changes in body composition analysis results before and 12 weeks after the start of IDPN
Safety outcomes
1) Changes in the area over the glucose curve < 70 mg･24 h/dL (AOC < 70) on the dialysis day calculated from glucose levels measured using a Flash Glucose Monitoring System (FGM) before and 12 weeks after the start of IDPN
2) Changes in AOC < 70 on non-dialysis days calculated from glucose levels measured using FGM before and 12 weeks after start of IDPN
3) Changes in the area under the glucose curve > 400 mg･24 h/dL (AUC >400) calculated from glucose levels measured using FGM before and 12 weeks after the start of IDPN
4) Changes in electrolytes, brain natriuretic peptide (BNP), bicarbonate ion, etc. before, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the start of IDPN
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous injection of 1 bag of ENEFLUID Injection (550 mL) three times weekly during hemodialysis sessions over 12 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Maintenance hemodialysis due to chronic kidney disease
2) High nutritional risk according to the nutritional risk index for Japanese hemodialysis patients (NRI-JH)
Key exclusion criteria
1) Pregnant or wanting to become pregnant
2) Initiation of hemodialysis within the past 180 days
3) Not expected to survive for 12 weeks due to severe infection or malignant tumor
4) Deemed ineligible for the study by the attending physician for any medical reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Hosojima |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Clinical Nutrition Science
Zip code
9518510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata 951-8510 Japan
TEL
025-368-9312
hoso9582@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Kabasawa |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Clinical Nutrition Science
Zip code
9518510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata 951-8510 Japan
TEL
025-368-9312
Homepage URL
hkabasawa@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Niigata University Medical & Dental Hospital
Nagaoka Chuo General Hospital
Niigata Saiseikai Sanjo Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Niigata University School of Medicine
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata 951-8510 Japan
Tel
025-227-2006
ethics@adm.niigata-u.ac.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
新潟大学医歯学総合病院/Niigata University Medical & Dental Hospital
長岡中央総合病院/ Nagaoka Chuo General Hospital
新潟県済生会三条病院/ Niigata Saiseikai Sanjo Hospital
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1186/s41100-022-00432-5
Number of participants that the trial has enrolled
13
Results
Results date posted
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
| 2021 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 27 | Day |
Last modified on
| 2022 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050256
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| Registered date | File name |
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