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The German ADPKD Tolvaptan Treatment Registry

ConditionADPKD (Autosomal Dominant Polycystic Kidney Disease)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Cologne

About this trial

The German ADPKD Tolvaptan Treatment Registry is a prospective, observational, multicentric study of patients suffering from ADPKD that are considered for tolvaptan treatment. All ADPKD patients that are evaluated for treatment indication, or that are planned to be treated with tolvaptan, or that are already treated with tolvaptan are eligible. This registry is designed to provide "real-world" data on treatment management of patients with ADPKD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

ADPKD proven by positive family history and evidence of renal cysts or diagnosed by treating physician

Presentation at our center for tolvaptan treatment indication, or tolvaptan treatment planned, or tolvaptan already started

Disqualifiers

Patients not capable of giving informed consent

End stage renal disease requiring renal replacement therapy

Patients receiving tolvaptan as "off-label use"

Trial population

Patients with diagnosis of ADPKD and therapy with tolvaptan

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group
Group A: ADPKD

Trial outcomes

Primary outcomes

1

Drug dosing and titration as a measure of changes in real-life setting

Drug dosing and titration as a measure of maximum dose and the final dose and how fast it is achieved

Time frame
10 years
2

Urine osmolarity as a measure of appropriate dosing

Data on urine osmolarity will be collected to measure appropriate dosing to provide the desired protective effect

Time frame
10 years
3

Evaluation of rate of drug discontinuation and average Duration of therapy

Evaluation of rate of drug discontinuation and average Duration of therapy

Time frame
10 years

Secondary outcomes

1

Demographics

Data on demographics will be collected

Time frame
10 years
2

Clinical and biochemical characteristics at enrolment and treatment initiation

Time frame
10 years
3

Clinical and biochemical characteristics during follow-up

Time frame
10 years
4

Urinary output

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cologne

Lead sponsor

University Hospital of Cologne

Sponsor institution

Source ClinicalTrials.gov
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