Tolvaptan Extension Study in Participants With ADPKD
Condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Tolvaptan
Intervention description: Tablets of 15 or 30 mg
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1083.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney Disease; ADPKD; Autosomal Dominant Polycystic Kidney Disease; Adult Polycystic Kidney Disease

Summary:

      To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from
      Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.
    

Eligibility criteria:

        Inclusion Criteria:

        - Participants who had successfully completed a Phase 1, 2, or 3 tolvaptan ADPKD or renal
        impairment study, with a confirmed diagnosis of ADPKD from prior studies [either 156-04-251
        (NCT00428948) or 156-04-250 (NCT00413777), 156-06-260, 156-09-284 (NCT01336972), 156-09-285
        (NCT01210560), and 156-09-290 (NCT01451827)].

        Exclusion Criteria:

          -  Participants unable to provide written informed consent.

          -  Participants (men or women) would not adhere to the reproductive precautions as
             outlined in the Informed Consent Form.

          -  Participants (women only) with a positive urine pregnancy test.

          -  Participants who were pregnant or breast-feeding.

          -  Participants unable to take oral medications.

          -  Participants who had allergic reactions to tolvaptan or chemically related structures
             such as benzazepines (benzazepril, conivaptan, fenoldopam mesylate, or mirtazapine).

          -  Participants with disorders in thirst recognition or an inability to access fluids.

          -  Participants with critical electrolyte imbalances, as determined by the investigator

          -  Participants with or at risk of significant hypovolemia, as determined by
             investigator.

          -  Participants with significant anemia, as determined by investigator.

          -  Participants with a history of substance abuse (within the last 3 years).

          -  Participants who were taking other experimental (that is, non-marketed) therapies or
             were participating in another clinical drug or device study; participating in the
             off-drug follow-up period of another ADPKD trial with tolvaptan was permitted.

          -  Participants unable to complete magnetic resonance imaging (MRI) assessments (for
             example, participants with ferro-magnetic prostheses, aneurysm clips, severe
             claustrophobia).

          -  Participants who had taken a vasopressin antagonist (outside of previous participation
             in a tolvaptan study).

          -  Participants unable to comply with anti-hypertensive or other important medical
             therapy.

          -  Participants with advanced diabetes.

          -  Participants who were taking medications or had an illness that could confound
             endpoint assessments (including taking approved therapies for the purpose of affecting
             polycystic kidney disease [PKD] cysts).