UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046275
Receipt number R000052804
Scientific Title The effect of dapagliflozin in autosomal dominant polycystic kidney disease patients using tolvaptan: randomized crossover controlled trial
Date of disclosure of the study information 2021/12/06
Last modified on 2023/12/05 12:30:23

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Basic information

Public title

The effect of dapagliflozin in autosomal dominant polycystic kidney disease patients using tolvaptan: randomized crossover controlled trial

Acronym

The effect of dapagliflozin in autosomal dominant polycystic kidney disease patients using tolvaptan

Scientific Title

The effect of dapagliflozin in autosomal dominant polycystic kidney disease patients using tolvaptan: randomized crossover controlled trial

Scientific Title:Acronym

The effect of dapagliflozin in autosomal dominant polycystic kidney disease patients using tolvaptan

Region

Japan


Condition

Condition

Autosomal dominant polycystic kidney disease (ADPKD)

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To demonstrate the efficacy of dapagliflozin in ameliorating renal function decline and total kidney volume growth in ADPKD patients using tolvaptan

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Decline in renal function [eGFR slope is calculated using the least squares method for secular change in eGFR (mL/min/1.73m2/year) from one month to 6 months in each trial]

Key secondary outcomes

Change in total kidney volume from baseline to 6 months in each trial

Body weight, blood pressure, metabolic parameters (serum TC/HDL/TG, fasting glucose, HbA1c, HOMA-IR), CKD-related outcomes by urine storage (urine volume, urine osmolality, urine protein and trace albumin, L-FABP), etc., obtained at 6 months in each trial (or those changes from baseline to 6 months)


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Dapagliflozin 10mg/day for 6 months

Interventions/Control_2

No treatment for 6 months

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


Not applicable

Gender

Male and Female

Key inclusion criteria

ADPKD patients using tolvaptan

Key exclusion criteria

Exclusion criteria are as follows: patients with eGFR less than 25 mL/min/1.73m2; diabetes mellitus (patients who are taking antidiabetic medication or meet the diagnostic criteria for diabetes mellitus); contraindications to the use of dapagliflozin (specifically, the following: patients with a history of hypersensitivity to any of the components of this drug; severe ketosis; diabetic coma, or precoma; severe infections, before and after surgery, or with severe trauma); less than 3 month-use of tolvaptan; deemed unsuitable as subjects by the study investigator.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kiyotaka
Middle name
Last name Uchiyama

Organization

Keio University School of Medicine

Division name

Department of Endocrinology, Metabolism and Nephrology

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

+81-3-5363-3796

Email

kiyo.0103.piyo@keio.jp


Public contact

Name of contact person

1st name Kiyotaka
Middle name
Last name Uchiyama

Organization

Keio University School of Medicine

Division name

Department of Endocrinology, Metabolism and Nephrology

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

+81-3-5363-3796

Homepage URL


Email

kiyo.0103.piyo@keio.jp


Sponsor or person

Institute

Department of Endocrinology, Metabolism and Nephrology, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

N/A

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Nephrology, International University of Health and Welfare School of Medicine
Division of Nephrology, Japanese Red Cross Medical Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research Ethics Committee, Keio University, School of Medicine

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

Tel

+81-3-5363-3503

Email

med-rinri-jimu@adst.keio.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

慶應義塾大学病院(東京都)
国際医療福祉成田大学病院 (千葉県)
国際医療福祉大学病院(栃木県)
国際医療福祉大学熱海病院(静岡県)
日本赤十字社医療センター(東京都)


Other administrative information

Date of disclosure of the study information

2021 Year 12 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

30

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

No longer recruiting

Date of protocol fixation

2021 Year 11 Month 30 Day

Date of IRB

2021 Year 12 Month 03 Day

Anticipated trial start date

2021 Year 12 Month 11 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 12 Month 03 Day

Last modified on

2023 Year 12 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052804


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name