UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randmized Controlled Trial for validity and safety to effect of high hemoglobin(Hb) level on kidney function post kidney transplant recipients.
Title of the study (Brief title)	Clinical study in anemia post kidney transplant recipients
Region	Japan

Condition
Condition	Chronic kidney disease after kidney transplantation
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the optimal range of anemia after kideny transplantation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference between Hb normal group and Hb subnormal group in rate of decline in kidney function for 5 years
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Hb normal group Target Hb level 13g/dl with erythropoietin stimulating agents(ESA)
Interventions/Control_2	Hb subnormal group Target Hb level 11g/dl with or without erythropoietin stimulating agents(ESA)
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1.More than 1 year after kidney transplantation 2.Stable kidney function for at least 3 months 3.eGFR of 15-50 ml/min/1.73m2 4.Hb level of 9.0-11.5 g/dl with or without ESA 5.Patients who give written informed consent
Key exclusion criteria	1.Urine protein more than 1g/day 2.Deterionation of kidney function within the preceding 3 months 3.History of acute rejection within 3 months 4.Uncontrolled hypertension(systolic blood pressure>140,diastolic blood pressure>100) 5.Active or uncontrolled infection 6.Prior diagnosis of malignancy 7.Iron deficiency anemia 8.Hemorrhage diathesis 9.Hb<10g/dl with ESA 10.Pregnancy or lactation 11.History of myocardial infarctioin or angina pectoris 12.History of cerebral infarction with any symptom 13.Hypersensitivity reactions to ESA
Target sample size	100

Research contact person
Name of lead principal investigator	Yoshihiko Watarai
Organization	Nagoya Daini Red Cross Hospital
Division name	Transplant Surgery
Address	2-9 Myoken-cho Syowa-ku Nagoya-shi
TEL	052-832-1121
Email	watarai@nagoya2.jrc.or.jp

Public contact
Name of contact person	Makoto Tsujita
Organization	Nagoya Daini Red Cross Hospital
Division name	Transplant Surgery
Address	2-9 Myoken-cho Syowa-ku Nagoya-shi
TEL	052-832-1121
Homepage URL
Email	tsujita4850@nagoya2.jrc.or.jp

Sponsor
Institute	Nagoya Daini Red Cross Hospital
Institute
Department

Funding Source
Organization	Nagoya Daini Red Cross Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Masuko Memorial Hospital
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	2012 Year 12 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 05 Month 24 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date	2017 Year 07 Month 19 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	2012 Year 12 Month 20 Day
Last modified on	2017 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011212