UMIN-CTR Clinical Trial

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