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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000031691
Receipt No. 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

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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
Email 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
Email ohtake@shonakamakura.or.jp

Sponsor
Institute Kidney Disease and Transplant Center,
Shonan Kamakura General Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036162

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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