UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031691 |
|---|---|
| Receipt number | R000036162 |
| Scientific Title | Autologous peripheral blood-derived CD34+ cell transplantation for acute kidney injury. |
| Date of disclosure of the study information | 2018/03/26 |
| Last modified on | 2020/03/16 17:07:17 |
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Basic information
Public title
Autologous peripheral blood-derived CD34+ cell transplantation for acute kidney injury.
Acronym
CD34+ cell Transplantation for acute kidney injury
Scientific Title
Autologous peripheral blood-derived CD34+ cell transplantation for acute kidney injury.
Scientific Title:Acronym
CD34+ cell Transplantation for acute kidney injury
Region
| Japan |
Condition
Condition
acute kidney injury
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety and efficacy of autologous peripheral blood-derived CD34+ cell transplantation for patients with acute kidney injury who require hemodialysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
safety for 52 weeks after cell transplantation (adverse events, adverse effects according to CTCAE)
Key secondary outcomes
1) withdrawal rate from hemodialysys at 2, 4, 12, 26, 52 weeks after cell transplantation.
2) change of serum creatinine, eGFR, and urinary findings until 52 weeks after cell transplantation.
3) death and death cause during 52 weeks after cell transplantation.
4) cell separation, purity, and viability
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
After G-CSF s.c. (5 ug/kg) for 5 days, peripheral blood mononuclear cell will be separated. At day 6, CD34+ cells will be separated using CliniMACS system. Purified CD34+ cells will be injected via bilateral renal arteries.
Low dose group: 500,000 cells/kg/kidney
middle dose group: 1000,000 cells/kg/kidney
high dose group: 2000,000 cells/kg/kidney
This clinical trial will be held as dose-escalation study from low dose group (n=3), to middle dose group (n=3), and then high dose group (n=3) after confirmation of safety of cell transplantation in each group.
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
1) patients with acute renal failure who require hemodialysis.
2) patient with urinary N-GAL 104 ug/g creatinine or more
3) patients who gave written informed consent
4) patients who have data of renal function within 12 months prior to inclusion
Key exclusion criteria
1) shock vital.
2) respiratory failure who require mechanical ventilation.
3) pre-renal or post-renal acute renal failure
4) maintenance dialysis (HD or PD)
5) severely damaged cardiac function (EF<25%)
6) allergic reaction to GCSF, apheresis, or mouse anti CD34 antibody
7) past history of renal transplantation
8) malignancy or past history within past 5 years
9) diabetic proliferating retinopathy (B2 or more)
10) within 3 months from angina pectoris, myocardial infarction, or stroke
11) leukemia, myelo-proliferating disease, myelodyslastic syndrome, sickle cell anemia
12) autoimmune disease
13) liver cirrhosis
14) interstitial pneumonia
15) brain aneurysm which need treatment
16) white blood cell count <3000/uL or >15000/uL
17) platelet count <50000/uL
18) hemoglobin < 8 g/dL
19) AST or ALT >100 IU/L
20) albumin < 2g/dL
21) splenomegaly on CT imaging
22) pregnant woman
23) patients who have HBV, HCV, HIV, HTLV1
24) single kidney
25) patients who join other clinical study
26) patients who are judged not to be appropriate to participate in this study
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuzo Kobayashi |
Organization
Shonan Kamakura General Hospital
Division name
Kidney Disease and Transplant Center
Zip code
Address
1370-1 Okaoto, kamakura, 247-8533, Japan
TEL
0467-46-1717
shuzo@shonankamakura.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayasu Ohtake |
Organization
Shonan Kamakura General Hospital
Division name
Kidney Disease and Transplant Center
Zip code
Address
1370-1 Okamoto, Kamakura, 247-8533, Japan
TEL
0467-46-1717
Homepage URL
ohtake@shonakamakura.or.jp
Sponsor or person
Institute
Kidney Disease and Transplant Center,
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushukai Medical Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
湘南鎌倉総合病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Please refer to the information in jRCT (jRCTb030190231) on and after February 27, 2020.
Management information
Registered date
| 2018 | Year | 03 | Month | 12 | Day |
Last modified on
| 2020 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036162
