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Canadian Medical Assessment of JINARC™ Outcomes Registry (C-MAJOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02925221
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
Otsuka Canada Pharmaceutical Inc.

Brief Summary:
This study is part of the Health Canada approval requirement for 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 tolvatan (JINARC™)

Condition or disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canadian Observational Cohort Study of the Real-life Assessment of Tolvaptan (JINARC™) in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study Start Date : January 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Tolvaptan

Group/Cohort
ADPKD patients on tolvaptan
ADPKD patients who are newly prescribed with tolvaptan or already treated with tolvaptan will be eligible.



Primary Outcome Measures :
  1. Changes from baseline in Medical Outcomes Study Short-Form 12 (MOS-SF-12v2) score [ Time Frame: Maximum of 48 months ]
  2. Changes from baseline in Autosomal Dominant Polycystic Kidney Disease-Impact Scale (ADPKD-IS) score [ Time Frame: Maximum of 48 months ]
  3. Changes from baseline in ADPKD - Pain & Discomfort Scale (ADPKD-PDS) score [ Time Frame: Maximum of 48 months ]
  4. Description of Health Care Resource Utilization [ Time Frame: Maximum of 48 months ]
  5. Work and productivity loss measured with the Work Productivity and Activity Impairment (WPAI) questionnaire [ Time Frame: Maximum of 48 months ]

Secondary Outcome Measures :
  1. Time to renal replacement therapy [ Time Frame: Maximum of 48 months ]
  2. Long-term mortality rate and causes [ Time Frame: Maximum 48 months ]
  3. Changes in markers of renal function [ Time Frame: Maximum of 48 months ]
    Markers of renal function: Total Kidney Volume (mL); Kidney Length (cm); estimated Glomerular Filtration Rate (eGFR); Chronic Kidney Disease (CKD) stage

  4. Adherence to treatment measured with the Medication Adherence Questionnaire [ Time Frame: Maximum of 48 months ]
  5. Time to tolvaptan treatment discontinuation [ Time Frame: Maximum of 48 months ]
  6. Long-term safety profile of tolvaptan [ Time Frame: Maximum of 48 months ]
    Incidence of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will be adult patients newly prescribed with tolvaptan for the treatment of ADPKD, or patients who are on-treatment with tolvaptan at the time of enrolment. Investigator must be ADPKD experts qualified by experience and ability to perform the study.
Criteria

Inclusion Criteria:

  • ADPKD patients ≥18 years old at the time of tolvaptan initiation
  • The treating physician must have reached the decision to treat the patient with 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

Exclusion Criteria:

  • The patient does not comprehend or refuses to sign the informed consent
  • The patient has any contraindications to the use of 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925221


Contacts
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Contact: Annick Laplante +1 514-332-3137 Annick.Laplante@otsuka-ca.com

Locations
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Canada, Alberta
Recruiting
Edmonton, Alberta, Canada
Canada, New Brunswick
Recruiting
Moncton, New Brunswick, Canada
Recruiting
Saint John, New Brunswick, Canada
Canada, Nova Scotia
Active, not recruiting
Halifax, Nova Scotia, Canada
Recruiting
Sydney, Nova Scotia, Canada
Canada, Ontario
Recruiting
Brampton, Ontario, Canada
Recruiting
London, Ontario, Canada
Recruiting
Mississauga, Ontario, Canada
Recruiting
Ottawa, Ontario, Canada
Active, not recruiting
Richmond Hill, Ontario, Canada
Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Recruiting
Greenfield Park, Quebec, Canada
Recruiting
Montreal, Quebec, Canada
Recruiting
Quebec City, Quebec, Canada
Recruiting
Rimouski, Quebec, Canada
Sponsors and Collaborators
Otsuka Canada Pharmaceutical Inc.
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Responsible Party: Otsuka Canada Pharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT02925221    
Other Study ID Numbers: 156-203-00047
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: January 18, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Otsuka Canada Pharmaceutical Inc.:
Kidney Disease
ADPKD-Related Outcome
Quality of Life
Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Congenital Abnormalities
Kidney Diseases, Cystic
Abnormalities, Multiple
Ciliopathies
Genetic Diseases, Inborn