UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Takahiro Kuragano
Organization	Hyogo College of Medicine
Division name	Internal Medicine (Nephrology and Dialysis)
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	Takahiro Kuragano
Organization	Hyogo College of Medicine
Division name	Internal Medicine (Nephrology and Dialysis)
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 03 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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