UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015245
Receipt number R000017722
Scientific Title Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment.
Date of disclosure of the study information 2014/09/25
Last modified on 2021/09/30 10:17:36

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Basic information

Public title

Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment.

Acronym

ADPKD confirmatory study to establish the determinants of disease progression and response to tolvaptan treatment.

Scientific Title

Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment.

Scientific Title:Acronym

ADPKD confirmatory study to establish the determinants of disease progression and response to tolvaptan treatment.

Region

Japan


Condition

Condition

autosomal dominant polycystic kidney disease (ADPKD)

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate the efficacy and safety of tolvaptan as a new therapeutic drug for progressive autosomal dominant polycystic kidney disease(ADPKD).

Basic objectives2

Others

Basic objectives -Others

We investigate the determinants of disease progression and response to tolvaptan treatment in progressive autosomal dominant polycystic kidney disease (ADPKD) .

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

change of kidney function (eGFR)

Key secondary outcomes

total kidney volume
urine concentration
plasma AVP concentration
urine cAMP
incidence and severity of symptom related with ADPKD
(urine concentration ability, hypertension, kidney pain, kidney function, hematuria, kidney stone, kidney infection)


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

5

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

tolvaptan 60~120mg/day

Interventions/Control_2

tolvaptan less than 60mg/day
(in case of minimize dose recommended, for example; kidney dysfunction)

Interventions/Control_3

tolvaptan less than 60mg/day
(in case of minimize dose recommended, for example; kidney dysfunction)

Interventions/Control_4

no medication

Interventions/Control_5

tolvaptan less than 60mg/day of start dose
(in case of minimize start dose recommended, for example; less than 20 years old or more than 65 years old)

Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. ADPKD patient
2. total kidney volume is more than 750ml by CT or MRI, and also increased speed of total kidney volume is more than almost 5% per year.
3. The patient who was agreed informed consent.

Key exclusion criteria

(1) contraindicated patient of tolvaptan
1. patient who has past history of hypersensitivity to tolvaptan or similar compound (mozavaptan)
2. patient who is not able to feel thirst or is difficult to water intake.
3. hypernatremia
4. severe kidney dysfunction (eGFR less than 15mL/min/1.73m2)
5. present or past history of liver dysfunction by chronic hepatitis, or drug-induced liver dysfunction, excluding liver cyst in ADPKD
6. The pregnancy or the woman who may be pregnant.
(2) The patient judged inappropriate by study responsibility doctor.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kosaku
Middle name
Last name Nitta

Organization

Tokyo Women's Medical University

Division name

Department of Medicine four

Zip code

162-8666

Address

8-1, Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan

TEL

0333538111

Email

mtoshi@twmu.ac.jp


Public contact

Name of contact person

1st name Toshio
Middle name
Last name Mochizuki

Organization

Tokyo Women's Medical University

Division name

Department of Nephrology

Zip code

162-8666

Address

Kawada-cho

TEL

0333538111

Homepage URL


Email

mtoshi@twmu.ac.jp


Sponsor or person

Institute

Department of Nephrology, Tokyo Women's Medical University

Institute

Department

Personal name



Funding Source

Organization

None

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

Ethics committee, Tokyo Women's Medical University

Address

8-1 kawada-cho, Shinjuku-ku, Tokyo

Tel

0333538111

Email

krinri.bm@twmu.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

東京女子医科大学(東京都)


Other administrative information

Date of disclosure of the study information

2014 Year 09 Month 25 Day


Related information

URL releasing protocol

https://www.kireports.org/action/showPdf?pii=S2468-0249%2821%2901293-6

Publication of results

Published


Result

URL related to results and publications

https://www.kireports.org/action/showPdf?pii=S2468-0249%2821%2901293-6

Number of participants that the trial has enrolled

92

Results

The observation period was 2.4 years. U-AQP2 per milligram of urinary creatinine (U-AQP2/Cr) decreased from 67.8 to 20.7 fmol/mg urinary creatinine after 1 month of tolvaptan treatment. This initial change in U-AQP2/Cr was correlated with high baseline U-AQP2/Cr, low baseline eGFR, and a large initial change in eGFR (baseline to 1 month). The initial change in U-AQP2/Cr (baseline to 1 month) was strongly correlated with the annual change in TKV and eGFR in multivariable analysis.

Results date posted

2021 Year 09 Month 30 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with ADPKD who were administered tolvaptan in our hospital.

Participant flow

Follow up of patients with ADPKD who were administered tolvaptan in our hospital.

Adverse events

Liver dysfunction

Outcome measures

the annual change in total kidney volume
(TKV) and estimated glomerular filtration rate (eGFR)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 09 Month 10 Day

Date of IRB

2014 Year 08 Month 26 Day

Anticipated trial start date

2014 Year 09 Month 25 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 09 Month 25 Day

Last modified on

2021 Year 09 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017722


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name