UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021267 |
|---|---|
| Receipt number | R000024513 |
| Scientific Title | Longitudinal Efficacy and Safety Study of Tolvaptan on Autosomal Dominant Polycystic Kidney Disease Patients |
| Date of disclosure of the study information | 2016/03/12 |
| Last modified on | 2021/03/09 10:50:59 |
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Basic information
Public title
Longitudinal Efficacy and Safety Study of Tolvaptan on Autosomal Dominant Polycystic Kidney Disease Patients
Acronym
Efficacy Study of Tolvaptan on ADPKD Patients [LET-PKD study]
Scientific Title
Longitudinal Efficacy and Safety Study of Tolvaptan on Autosomal Dominant Polycystic Kidney Disease Patients
Scientific Title:Acronym
Efficacy Study of Tolvaptan on ADPKD Patients [LET-PKD study]
Region
| Japan |
Condition
Condition
Autosomal Dominant Polycystic Kidney Disease
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
1. Primary Objective
To assess the effect of tolvaptan on the percent change (% per year) in TKV volumetrically measured by MRT
-Supplementary assessment- Using "a" calculated from the following equation: [HtTKV at age t]= K (1+eAHTKV-a/100)t, as an indicator, the effect of tolvaptan on HtTKV slope will be supplementarily assessed.
2. Secondary Objectives
1)To assess the effects of tolvaptan on renal function
2)To assess the safety of tolvaptan
3)To assess the effects of tolvaptan based on the results of 24-hour urine collection, blood tests, inulin clearance, and TKV
4)To investigate inulin clearance and the clinical condition of ADPKD
5)To assess the relationship (correlation) between eGFR estimated using different formulae and inulin clearance, and the impact of tolvaptan on this correlation
6)To analyze the association between the results of DNA analysis (pathogenic genotype and mutation site) and the effect of tolvaptan in patients who have no available DNA analysis data and will newly undergo DNA analysis in the study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The percent change in TKV volumetrically measured by MRI (% per year) will be compared before and after the start of tolvaptan therapy within each patient. The evaluation includes stratified analyses by patient background factors, examination data obtained during the therapy, etc.
-Supplementary assessment of the primary outcome variable-
Using the "a" as an indicator, the effect of tolvaptan on HtTKV slope will be supplementarily assessed.
Key secondary outcomes
1) The percent change in eGFR (mL/min/1.73 m2 per year) will be compared before and after tolvaptan therapy. The evaluation includes stratified analyses by patient background factors, observation/examination data obtained during the therapy, etc.
2) The safety of tolvaptan will be evaluated. Safety data will be reported to Otsuka Pharmaceutical Co., Ltd., as specified by the protocol. The evaluation includes stratified analyses by patient background factors, examination data obtained during the therapy, etc.
3) Based on the results of 24-hour urine collection, blood tests, inulin clearance, and TKV, the effects of or response to tolvaptan will be evaluated. The evaluation includes stratified analyses by patient background factors, examination data obtained during the therapy, etc.
4) Patients are required to be hospitalized for the first dose of tolvaptan. The results of 24-hour urine collection, and inulin clearance, and other data obtained during the hospitalization will be used to assess the clinical conditions of ADPKD ,
5) The correlation between inulin clearance and eGFR estimated using different formulae will be investigated to elucidate the impact of tolvaptan on the correlation.
6) The association between the results of DNA analysis and the effect of tolvaptan will be analyzed.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients over the age of 18 who started or will start tolvaptan therapy at Kyorin University Hospital
2) Patients who meet the criteria for the use of Samsca specified by the Ministry of Health, Labour and Welfare
- TKV :750 ml or more
- TKV slope : approximately 5percent per year or more
3) Patients for whom the TKV and eGFR (percent change) data before the start of tolvaptan therapy are available
4) Patients who freely provided written informed consent to participate in the study
Key exclusion criteria
1) Patients who have been taking tolvaptan since the TEMPO study
2) Patients who are not eligible, at the discretion of Kyorin University Hospital, to take tolvaptan for the stated indication according to the criteria for careful administration of Samsca as specified by the Ministry of Health, Labour and Welfare
- Patients with a history of hypersensitivity to tolvaptan or similar chemical compounds
- Patients who do not feel thirsty or have difficulty swallowing water
- Patients with hypernatremia
- Patients with eGFR less than 15 mL/min/1.73 m2
- Patients with chronic hepatitis, drug-induced hepatic dysfunction or other hepatic dysfunctions
- Pregnant women or women suspected of being pregnant. Female patients who wish to become pregnant
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Higashihara |
Organization
Autosomal Dominant Polycystic Kidney Disease Research Section, Kyorin University, School of Medicine
Division name
urology
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka, Tokyo 181-8611 Japan
TEL
+81-422-49-7428
ehigashi@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Higashihara |
Organization
Autosomal Dominant Polycystic Kidney Disease Research Section, Kyorin Univ., School of Med.
Division name
urology
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka, Tokyo 181-8611 Japan
TEL
+81-422-49-7428
Homepage URL
ehigashi@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Autosomal Dominant Polycystic Kidney Disease Research Section, Kyorin University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2 Shinkawa, Mitaka, Tokyo 181-8611 Japan
Tel
0422-47-5514
rec@ks.kyorin-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT0272966
Org. issuing International ID_1
the U.S. National Institutes of Health, ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
杏林大学医学部付属病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 12 | 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
119
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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 02 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Percent changes in TKV and eGFR will be compared before and after tolvaptan therapy
[Measurements]
TKV : At least once per year
eGFR : As appropriate
24-hour urine collection :
- Once per year (Before tolvaptan therapy)
-Twice per year (After tolvaptan therapy)
DNA : Once per patient
Management information
Registered date
| 2016 | Year | 03 | Month | 01 | Day |
Last modified on
| 2021 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024513
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