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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00019856

Enrollment

Registered

2020-01-16

Start date

2017-11-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q61.2

Interventions

Group 1: It is a non-interventional, monocentric, clinical study to determine the adherence to therapy with tolvaptan therapy in autosomal dominant polycystic kidney disease (ADPKD). The study will in

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: Patients who do not meet the inclusion criteria.

Design outcomes

Primary

Measure	Time frame
The primary outcome is therapy adherence.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany

Contacts

Public ContactHolger Schirutschke

Universitätsklinikum Carl Gustav Carus an der TU Dresden, Anstalt öffentlichen Rechts

Holger.Schirutschke@uniklinikum-dresden.de0351/4584233

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026