Open-Label Tolvaptan Study in Subjects With ADPKD

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01214421
• Date of registration: 26/09/2010
• Prospective Registration: No
• Primary sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Public title: Open-Label Tolvaptan Study in Subjects With ADPKD TEMPO 4/4
• Scientific title: Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
• Date of first enrolment: May 2010
• Target sample size: 1083
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01214421
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Romania, Russian Federation, United Kingdom, United States

Contacts

• Name: Frank Czerwiec, MD, PhD
• Affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

Subjects who have successfully completed a Phase 1, 2, or 3 tolvaptan ADPKD or renal
impairment trial, with a confirmed diagnosis of ADPKD

Exclusion Criteria:

- Subjects unable to provide written informed consent

- Subjects (men or women) who will not adhere to the reproductive precautions as
outlined in the Informed Consent Form

- Subjects (women only) with a positive urine pregnancy test

- Subjects who are pregnant or breast-feeding

- Subjects unable to take oral medications

- Subjects who have allergic reactions to tolvaptan or chemically related structures
such as benzazepines (benzazepril, conivaptan, fenoldopam mesylate or mirtazapine)

- Subjects who have disorders in thirst recognition or an inability to access fluids

- Subjects with critical electrolyte imbalances, as determined by the investigator

- Subjects with or at risk of significant hypovolemia, as determined by investigator

- Subjects with anemia, as determined by investigator

- Subjects with a history of substance abuse (within the last 3 years)

- Subjects taking other experimental (ie, non-marketed) therapies or current
participation in another clinical drug or device trial; current participation in the
off-drug follow-up period of another ADPKD trial with tolvaptan is permitted

- Subjects unable to complete MRI assessments(eg, subjects with ferro-magnetic
prostheses, aneurysm clips, severe claustrophobia)

- Subjects who have taken a vasopressin antagonist (outside of previous participation in
a tolvaptan trial)

- Subjects unable to comply with anti-hypertensive or other important medical therapy

- Subjects with advanced diabetes

- Subjects taking medications or having an illness that could confound endpoint
assessments (including taking approved therapies for the purpose of affecting PKD
cysts)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Intervention(s)

Drug: Tolvaptan

Primary Outcome(s)

Percent Change in Total Kidney Volume (TKV) [Time Frame: 24 months]

Secondary Outcome(s)

Slope of eGFR (CKD-EPI) [Time Frame: 24 months]

Slope of Total Kidney Value (TKV) [Time Frame: 24 months]

Change in Estimated Glomerular Filtration Rate (eGFR) [Time Frame: 24 months]

Secondary ID(s)

156-08-271

2010-018401-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors