Autosomal Dominant Polycystic Kidney Disease (ADPKD)C-MAJORNCT02925221
Canadian Medical Assessment of JINARC™ Outcomes Registry
An observational study of Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Otsuka Canada Pharmaceutical Inc. at 6 sites in Canada.
Trial summary
This study is part of the Health Canada approval requirement for JINARC™ (tolvaptan) and is an observational, non-interventional study (NIS) describing the impact of tolvaptan on ADPKD-related burden of illness as measured with a set of Patient Reported Outcome (PRO) Questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- How many people
- 530 participants
- Where
- 6 sitesCanada
- Study dates
- 26 Feb 2016to 31 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be adult patients newly prescribed with JINARC™ (tolvaptan) for the treatment of ADPKD, or patients who are on-treatment with JINARC™ (tolvaptan) at the time of enrolment. Investigator must be ADPKD experts qualified by experience and ability to perform the study.
Who may be able to join
- ADPKD patients ≥18 years old at the time of tolvaptan initiation
- The treating physician must have reached the decision to treat the patient with JINARC™ (tolvaptan) as per the Canadian Product Monograph prior to and independently of soliciting the patient to participate in the study
- The patient or legal guardian must have signed an informed consent indicating the understanding of the study and allowing the use of their anonymous data for the purposes of the study
Who cannot join
- The patient does not comprehend or refuses to sign the informed consent
- The patient has any contraindications to the use of JINARC™ (tolvaptan) as specified in the Canadian Product Monograph
- The patient has any condition which, as per the judgment of the treating physician, prohibits them from participating in the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Study site
Edmonton, Alberta
Study site
London, Ontario
Study site
Montreal, Quebec
Study site
Ottawa, Ontario
Study site
Québec, Quebec
Study site
Toronto, Ontario
About this study
Official title: Canadian Observational Cohort Study of the Real-life Assessment of Tolvaptan (JINARC™) in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
This study is part of the Health Canada approval requirement for JINARC™ (tolvaptan) and is an observational, non-interventional study (NIS) describing the impact of tolvaptan on ADPKD-related burden of illness as measured with a set of Patient Reported Outcome (PRO) Questionnaires. The study is also describing the time to renal replacement therapy (RRT), such as dialysis and transplantation, and the long-term mortality rate and causes (i.e. renal and hepatic), in ADPKD patients treated with JINARC™ (tolvaptan)
- Keywords
- Kidney Disease, ADPKD-Related Outcome, Quality of Life
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Kidney Diseases
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 |
|---|---|---|
| ADPKD patients on tolvaptan | ADPKD patients who are newly prescribed with JINARC™ (tolvaptan) or already treated with JINARC™ (tolvaptan) will be eligible. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Medical Outcomes Study Short-Form 12 (MOS-SF-12v2) score
Measured: Maximum of 120 months
Changes from baseline in Autosomal Dominant Polycystic Kidney Disease-Impact Scale (ADPKD-IS) score
Measured: Maximum of 120 months
Changes from baseline in ADPKD - Pain & Discomfort Scale (ADPKD-PDS) score
Measured: Maximum of 120 months
Description of Health Care Resource Utilization
Measured: Maximum of 120 months
Work and productivity loss measured with the Work Productivity and Activity Impairment (WPAI) questionnaire
Measured: Maximum of 120 months
Secondary outcomes (6)
Time to renal replacement therapy
Measured: Maximum of 120 months
Long-term mortality rate and causes
Measured: Maximum 120 months
Changes in markers of renal function
Markers of renal function: Total Kidney Volume (mL); Kidney Length (cm); estimated Glomerular Filtration Rate (eGFR); Chronic Kidney Disease (CKD) stage
Measured: Maximum of 120 months
Adherence to treatment measured with the Medication Adherence Questionnaire
Measured: Maximum of 120 months
Time to tolvaptan treatment discontinuation
Measured: Maximum of 120 months
Long-term safety profile of tolvaptan
Incidence of adverse events
Measured: Maximum of 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start26 Feb 2016
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Canada Pharmaceutical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925221
- Sponsor's protocol ID
- 156-203-00047
- Acronym
- C-MAJOR
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2016
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Participants consenting to share their data are consented and identified as such in the clinical database.
Publications
McFarlane P, Bichet DG, Alam A, Bubolic S, Laplante A. Eight Years of Canadian Real-World Assessment of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease: The C-MAJOR Registry. Can J Kidney Health Dis. 2026 Jan 13;13:20543581251404128. doi: 10.1177/20543581251404128. eCollection 2026.
PubMed 41541406
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Observational Cohort Study of the Real-life Assessment of Tolvaptan (JINARC™) in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- ClinicalTrials.gov ID
- NCT02925221
- Acronym / sponsor ID
- C-MAJOR / 156-203-00047
- Keywords
- Kidney Disease, ADPKD-Related Outcome, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Otsuka Canada Pharmaceutical Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2016 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 5 Oct 2016 (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 study is part of the Health Canada approval requirement for JINARC™ (tolvaptan) and is an observational, non-interventional study (NIS) describing the impact of tolvaptan on ADPKD-related burden of illness as measured with a set of Patient Reported Outcome (PRO) Questionnaires. The study is also describing the time to renal replacement therapy (RRT), such as dialysis and transplantation, and the long-term mortality rate and causes (i.e. renal and hepatic), in ADPKD patients treated with JINARC™ (tolvaptan)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADPKD patients on tolvaptan | – | –ADPKD patients who are newly prescribed with JINARC™ (tolvaptan) or already treated with JINARC™ (tolvaptan) will be eligible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be adult patients newly prescribed with JINARC™ (tolvaptan) for the treatment of ADPKD, or patients who are on-treatment with JINARC™ (tolvaptan) at the time of enrolment. Investigator must be ADPKD experts qualified by experience and ability to perform the study.
Key inclusion criteria (3 listed)
- ADPKD patients ≥18 years old at the time of tolvaptan initiation
- The treating physician must have reached the decision to treat the patient with JINARC™ (tolvaptan) as per the Canadian Product Monograph prior to and independently of soliciting the patient to participate in the study
- The patient or legal guardian must have signed an informed consent indicating the understanding of the study and allowing the use of their anonymous data for the purposes of the study
Key exclusion criteria (3 listed)
- The patient does not comprehend or refuses to sign the informed consent
- The patient has any contraindications to the use of JINARC™ (tolvaptan) as specified in the Canadian Product Monograph
- The patient has any condition which, as per the judgment of the treating physician, prohibits them from participating in the study
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
Changes from baseline in Medical Outcomes Study Short-Form 12 (MOS-SF-12v2) score
Time frame: Maximum of 120 months
Changes from baseline in Autosomal Dominant Polycystic Kidney Disease-Impact Scale (ADPKD-IS) score
Time frame: Maximum of 120 months
Changes from baseline in ADPKD - Pain & Discomfort Scale (ADPKD-PDS) score
Time frame: Maximum of 120 months
Description of Health Care Resource Utilization
Time frame: Maximum of 120 months
Work and productivity loss measured with the Work Productivity and Activity Impairment (WPAI) questionnaire
Time frame: Maximum of 120 months
6 secondary outcomes
Time to renal replacement therapy
Time frame: Maximum of 120 months
Long-term mortality rate and causes
Time frame: Maximum 120 months
Changes in markers of renal function
Time frame: Maximum of 120 months
Adherence to treatment measured with the Medication Adherence Questionnaire
Time frame: Maximum of 120 months
Time to tolvaptan treatment discontinuation
Time frame: Maximum of 120 months
Long-term safety profile of tolvaptan
Time frame: Maximum of 120 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 7 Jan 2026.
- Derived from this study: PubMed 41541406McFarlane P, Bichet DG, Alam A, Bubolic S, Laplante A. Eight Years of Canadian Real-World Assessment of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease: The C-MAJOR Registry. Can J Kidney Health Dis. 2026 Jan 13;13:20543581251404128. doi: 10.1177/20543581251404128. eCollection 2026.
- Individual participant dataSharing planned: Yes. Participants consenting to share their data are consented and identified as such in the clinical database.
Related trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Active, not recruitingObservational study
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Autosomal Dominant Polycystic Kidney Disease
Not yet recruitingPhase 1
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
ADPKD (Autosomal Dominant Polycystic Kidney Disease), Renal Edema
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Active, not recruitingObservational study
Polycystic Kidney Disease 1 (PKD1) Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites 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 (ADPKD), run by Otsuka Canada Pharmaceutical Inc. at 6 sites in Canada.
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 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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?
Changes from baseline in Medical Outcomes Study Short-Form 12 (MOS-SF-12v2) score (time frame: Maximum of 120 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02925221, which also lists 1 linked publication.
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 7 Jan 2026.