UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000773
Receipt number 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 09:57:48

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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 or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



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

Value
https://center6.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