Unique ID issued by UMIN | UMIN000009594 |
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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 |
Randmized Controlled Trial for validity and safety to effect of high hemoglobin(Hb) level on kidney function post kidney transplant recipients.
Clinical study in anemia post kidney transplant recipients
Randmized Controlled Trial for validity and safety to effect of high hemoglobin(Hb) level on kidney function post kidney transplant recipients.
Clinical study in anemia post kidney transplant recipients
Japan |
Chronic kidney disease after kidney transplantation
Nephrology |
Others
NO
To study the optimal range of anemia after kideny transplantation
Safety,Efficacy
Difference between Hb normal group and Hb subnormal group in rate of decline in kidney function for 5 years
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Hb normal group
Target Hb level 13g/dl with erythropoietin stimulating agents(ESA)
Hb subnormal group
Target Hb level 11g/dl with or without erythropoietin stimulating agents(ESA)
20 | years-old | <= |
70 | years-old | > |
Male and Female
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
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
100
1st name | |
Middle name | |
Last name | Yoshihiko Watarai |
Nagoya Daini Red Cross Hospital
Transplant Surgery
2-9 Myoken-cho Syowa-ku Nagoya-shi
052-832-1121
watarai@nagoya2.jrc.or.jp
1st name | |
Middle name | |
Last name | Makoto Tsujita |
Nagoya Daini Red Cross Hospital
Transplant Surgery
2-9 Myoken-cho Syowa-ku Nagoya-shi
052-832-1121
tsujita4850@nagoya2.jrc.or.jp
Nagoya Daini Red Cross Hospital
Nagoya Daini Red Cross Hospital
Self funding
Masuko Memorial Hospital
NO
2012 | Year | 12 | Month | 21 | Day |
Unpublished
Completed
2011 | Year | 05 | Month | 24 | Day |
2011 | Year | 12 | Month | 01 | Day |
2017 | Year | 07 | Month | 19 | Day |
2012 | Year | 12 | Month | 20 | Day |
2017 | Year | 07 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011212
Research Plan | |
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