Autosomal Dominant Polycystic Kidney DiseaseESWPNCT01348035
Efficacy Study of Water Drinking on PKD Progression.
An observational study of Autosomal Dominant Polycystic Kidney Disease and Disease Progression, run by Kyorin University at 1 site in Japan.
Trial summary
This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease, Disease Progression
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who visit Kyorin University Hospital.
Who may be able to join
- The patients with ADPKD
- The patients who consent to the study protocol
- Estimated glomerular filtration rate (eGFR) or Creatinine Clearance greater than 50ml/min/1.73m2
Who cannot join
- Patients who might be danger to drink large amount of water such as having heart failure or past history of cerebrovascular or cardiovascular disorders.
- The patients who take habitual medication which affects the AVP action such as selective serotonin reuptake inhibitors (SSRI ), tricyclic antidepressants or diuretics.
- The patients who is considered inappropriate by physicians.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Urology, Kyorin University Hospital
Mitaka, Tokyo, 181-8611
About this study
Official title: Efficacy Study of Long-term Water Intake on the Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD.
Read the detailed description
Tolvaptan was approved in Japan for the treatment of autosomal dominant polycystic kidney disease (ADPKD) in March 2014. This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD. Study results will be summarized, analyzed, and compiled into a research paper at 3 years (data cut-off, March 31, 2018) and at 5 years (data cut-off, March 31, 2020)
- Keywords
- Autosomal Dominant Polycystic Kidney Disease., Arginine vasopressin, Total Kidney Volume, Glomerular Filtration Rate
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Disease Progression, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Water Load Group | Water load group: 2.5 ~ 3 L water intake daily for 12 months (50ml/Kg body weight/day). When large amount water intake is not sustainable, patients can reduce the amount of water intake to the levels as much as large he or she can sustain. | |
| Non-Water Loaded Group | Non-water load group: The patients are free to access water intake, as they like. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total kidney volume (TKV) measured by magnetic resonance imaging (MRI).
The relationship between urine volume (and urine osmolality) and change of TKV. TKV slopes are compared between pre-study and study period.
Measured: One year (12 months) and pre-study period.
Secondary outcomes (3)
Glomerular filtration rate (GFR) estimated by plasma creatinine and cystatin C.
The relationship between urine volume (and urine osmolality) and change of GFR.
Measured: One year (12 months)
Plasma arginine vasopressin (AVP, Copeptin) level.
The relationship between urine volume (osmolality) and plasma AVP.
Measured: 4-8-12 months
Quality of life (QOL) questionnaire.
The relationship between QOL and urine volume.
Measured: 4-8-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eiji Higashihara, MD, Kyorin University
- Investigators
- Eiji Higashihara, M.D., Principal investigator, Kyorin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348035
- Sponsor's protocol ID
- KYR-003-PKD
- Acronym
- ESWP
- Status last verified
- Mar 2018
- First submitted
- 3 May 2011
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Long-term Water Intake on the Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
- ClinicalTrials.gov ID
- NCT01348035
- Acronym / sponsor ID
- ESWP / KYR-003-PKD
- Keywords
- Autosomal Dominant Polycystic Kidney Disease., Arginine vasopressin, Total Kidney Volume, Glomerular Filtration Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD.
Detailed description
Tolvaptan was approved in Japan for the treatment of autosomal dominant polycystic kidney disease (ADPKD) in March 2014. This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD. Study results will be summarized, analyzed, and compiled into a research paper at 3 years (data cut-off, March 31, 2018) and at 5 years (data cut-off, March 31, 2020)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water Load Group | – | –Water load group: 2.5 ~ 3 L water intake daily for 12 months (50ml/Kg body weight/day). When large amount water intake is not sustainable, patients can reduce the amount of water intake to the levels as much as large he or she can sustain. |
| Non-Water Loaded Group | – | –Non-water load group: The patients are free to access water intake, as they like. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who visit Kyorin University Hospital.
Key inclusion criteria (3 listed)
- The patients with ADPKD
- The patients who consent to the study protocol
- Estimated glomerular filtration rate (eGFR) or Creatinine Clearance greater than 50ml/min/1.73m2
Key exclusion criteria (3 listed)
- Patients who might be danger to drink large amount of water such as having heart failure or past history of cerebrovascular or cardiovascular disorders.
- The patients who take habitual medication which affects the AVP action such as selective serotonin reuptake inhibitors (SSRI ), tricyclic antidepressants or diuretics.
- The patients who is considered inappropriate by physicians.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total kidney volume (TKV) measured by magnetic resonance imaging (MRI).
Time frame: One year (12 months) and pre-study period.
The relationship between urine volume (and urine osmolality) and change of TKV. TKV slopes are compared between pre-study and study period.
3 secondary outcomes
Glomerular filtration rate (GFR) estimated by plasma creatinine and cystatin C.
Time frame: One year (12 months)
Plasma arginine vasopressin (AVP, Copeptin) level.
Time frame: 4-8-12 months
Quality of life (QOL) questionnaire.
Time frame: 4-8-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eiji Higashihara, M.D. principal investigator
Kyorin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autosomal Dominant Polycystic Kidney Disease and Disease Progression, run by Kyorin University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total kidney volume (TKV) measured by magnetic resonance imaging (MRI). (time frame: One year (12 months) and pre-study period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.