UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009594 |
|---|---|
| Receipt number | R000011212 |
| Scientific Title | Randmized Controlled Trial for validity and safety to effect of high hemoglobin(Hb) level on kidney function post kidney transplant recipients. |
| Date of disclosure of the study information | 2012/12/21 |
| Last modified on | 2017/07/19 06:43:53 |
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Basic information
Public title
Randmized Controlled Trial for validity and safety to effect of high hemoglobin(Hb) level on kidney function post kidney transplant recipients.
Acronym
Clinical study in anemia post kidney transplant recipients
Scientific Title
Randmized Controlled Trial for validity and safety to effect of high hemoglobin(Hb) level on kidney function post kidney transplant recipients.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Watarai |
Organization
Nagoya Daini Red Cross Hospital
Division name
Transplant Surgery
Zip code
Address
2-9 Myoken-cho Syowa-ku Nagoya-shi
TEL
052-832-1121
watarai@nagoya2.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Tsujita |
Organization
Nagoya Daini Red Cross Hospital
Division name
Transplant Surgery
Zip code
Address
2-9 Myoken-cho Syowa-ku Nagoya-shi
TEL
052-832-1121
Homepage URL
tsujita4850@nagoya2.jrc.or.jp
Sponsor or person
Institute
Nagoya Daini Red Cross Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2011 | Year | 05 | Month | 24 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011212
