UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000052433
Receipt number R000058733
Scientific Title A Multicenter Prospective Cohort Study to Establish a Predictive Model for the Treatment-Related Acute Kidney Disease by Noninvasive Tubular Aging Assessment
Date of disclosure of the study information 2023/10/06
Last modified on 2023/10/06 11:21:08

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Basic information

Public title

A Multicenter Prospective Cohort Study to Establish a Predictive Model for the Treatment-Related Acute Kidney Disease by Noninvasive Tubular Aging Assessment

Acronym

A Multicenter Prospective Cohort Study to Establish a Predictive Model for the Treatment-Related Acute Kidney Disease by Noninvasive Tubular Aging Assessment

Scientific Title

A Multicenter Prospective Cohort Study to Establish a Predictive Model for the Treatment-Related Acute Kidney Disease by Noninvasive Tubular Aging Assessment

Scientific Title:Acronym

A Multicenter Prospective Cohort Study to Establish a Predictive Model for the Treatment-Related Acute Kidney Disease by Noninvasive Tubular Aging Assessment

Region

Japan


Condition

Condition

acute kidney disease

Classification by specialty

Hematology and clinical oncology Nephrology Oto-rhino-laryngology
Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to longitudinally evaluate the association between the degree of tubular senescence diagnosed by blood and urine cytology and the incidence of treatment-related acute kidney disease (AKD) in patients undergoing anti-tumor chemotherapy for malignancy at our hospital.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Onset of treatment-related AKD (failure of renal function recovery on day 7 or 30 after initiation of treatment: > 0.3 mg/dl or 1.5-fold increase in serum Cr compared to baseline)

Key secondary outcomes

1) Serum biomarker (soluble serum alpha Klotho)
2) Number of cells positive for P16 and P53 antibodies in urine cytology
3) Renal death and induction of dialysis (temporary or permanent)
4) Onset of AKI (>0.3 mg/dl increase in Cr value or >1.5-fold increase in Cr value or oliguria compared to baseline value within 2 days of starting treatment) and its stage
5) Development of CKD (decrease to eGFR <60 ml/min/1.73 m2 or positive urine protein: >1+ over 3 months of treatment)
6) Survival and treatment success rate (whether the planned treatment could be continued or not)
7) Age, gender, original disease, comorbidity (hypertension, diabetes, liver disease), concomitant medications, blood pressure, BMI
8) Details of treatment (dose and frequency of anti-tumor therapy, renal ischemia time, contrast medium dose, and volume of replacement fluid)


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing anti-tumor chemotherapy

Key exclusion criteria

Under 16 years old

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Tadashi
Middle name
Last name Sofue

Organization

Kagawa University Hospital

Division name

Department of Nephrology

Zip code

761-0793

Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan

TEL

087-891-2150

Email

sofue.tadashi@kagawa-u.ac.jp


Public contact

Name of contact person

1st name Tadashi
Middle name
Last name Sofue

Organization

Kagawa University Hospital

Division name

Department of Nephrology

Zip code

7610793

Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan

TEL

087-891-2150

Homepage URL


Email

sofue.tadashi@kagawa-u.ac.jp


Sponsor or person

Institute

Kagawa University

Institute

Department

Personal name



Funding Source

Organization

Kagawa University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kagawa University

Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan

Tel

0878912150

Email

chiken-b.@med.kagawa-u.ac.jp


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

2023 Year 10 Month 06 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

Preinitiation

Date of protocol fixation

2023 Year 08 Month 25 Day

Date of IRB

2023 Year 09 Month 25 Day

Anticipated trial start date

2023 Year 10 Month 01 Day

Last follow-up date

2028 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observation study


Management information

Registered date

2023 Year 10 Month 06 Day

Last modified on

2023 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058733


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name