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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000773
Receipt No. R000000930
Scientific Title A competitive acetate-free bicarbonate dialysate and standard bicarbonate dialysate of iron metabolism dysregulation improvement and cytokine production chilling of hemodialysis patients : a cross-over multicenter study.
Date of disclosure of the study information 2007/07/30
Last modified on 2016/08/20

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Basic information
Public title A competitive acetate-free bicarbonate dialysate and standard bicarbonate dialysate of iron metabolism dysregulation improvement and cytokine production chilling of hemodialysis patients : a cross-over multicenter study.
Acronym Prospective Clinical Cross-over Study of Citrate Containg Dialyzate in hemodialysis patients. (CROCIT study)
Scientific Title A competitive acetate-free bicarbonate dialysate and standard bicarbonate dialysate of iron metabolism dysregulation improvement and cytokine production chilling of hemodialysis patients : a cross-over multicenter study.
Scientific Title:Acronym Prospective Clinical Cross-over Study of Citrate Containg Dialyzate in hemodialysis patients. (CROCIT study)
Region
Japan

Condition
Condition Patients, who are treated with maintenance hemodialysis more than one year
Classification by specialty
Nephrology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of iron metabolism improvement and cytokine production chilling in the patients with maintenance hemodialysis by acetate-free bicarbonate dialysate.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (i) dosages of rHuEPO and iron.
(ii) improvement of QOL .
(iii) iron-related index , inflammation, nutrition, oxidative stress, endthelial injury.
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
Medicine
Interventions/Control_1 one year in a 4-month cross-over study.
first stage : hemodialysis treatment with standard bicarbonate dialysate. (acetate-containing)
second stage: hemodialysis treatment with acetate-free bicarbonate dialysate. (citrate-containing)
third stage: hemodialysis treatment with standard bicarbonate. (acetate-containing)
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
75 years-old >=
Gender Male and Female
Key inclusion criteria (i) Patients with maintenance hemodialysis (age less than 75 years old).
(ii) Patients, whose duration of hemodialysis more than one year, and their hemodynamic state are stable.
(iii) Patients, who are received hemodialysis 3 times a week and 4 hours at a time.
(iv) Patients with renal anemia, who are treated with rHuEPO or iron.
Key exclusion criteria (i) Patients with chronic inflammation (CRP over 0.3), malignant disorder, severe respiratory organs, and liver disorder.
(ii) Patients, who are recived dialysis treatment except HD such as HF, HDF, and HDF.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Kuragano
Organization Hyogo College of Medicine
Division name Internal Medicine (Nephrology and Dialysis)
Zip code
Address 1-1 Mukokawa-cho, Nisinomiya city, Hyogo, Japan
TEL 0798-45-6111
Email kuragano@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Kuragano
Organization Hyogo College of Medicine
Division name Internal Medicine (Nephrology and Dialysis)
Zip code
Address 1-1 Mukokawa-cho, Nisinomiya city, Hyogo, Japan
TEL 0798-45-6111
Homepage URL
Email kuragano@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine, Internal Medicine (Nephrology and Dialysis)
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
Address
Tel
Email

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
2007 Year 07 Month 30 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
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
2007 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2007 Year 05 Month 01 Day
Last follow-up date
2008 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 07 Month 19 Day
Last modified on
2016 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000930

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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