10-year tolvaptan in ADPKD - A patient-based center evaluatio

• Conditions: Q61.2; Polycystic kidney, autosomal dominant

• Registration Number: DRKS00019856
• Lead Sponsor: Otsuka Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-06-10
• Study Start: 2020-01-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Adult ADPKD patients who have participated in both the TEMPO 3: 4 (Verum Group) and TEMPO 4: 4 trials and are currently receiving treatment with Jinarc® (tolvaptan).

Exclusion Criteria

Patients who do not meet the inclusion criteria.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is therapy adherence.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are the frequency of urological complications (gross hematuria, flank pain, cyst infections), the development of renal function (? eGFR), and the development of normalized total kidney volume (? htTKV) in the subgroup of patients at the individual decision of the physician new onset symptoms (renal pain, gross hematuria) during the study have been followed by computed tomography (CT) or magnetic resonance imaging (MRI) of the kidneys.