RecruitingNot Applicable

The German ADPKD Tolvaptan Treatment Registry

Germany2,000 participantsStarted 2015-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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 Exclusion Criteria: * Patients not capable of giving informed consent * End stage renal disease requiring renal replacement therapy * Patients receiving tolvaptan as "off-label use"

What they're measuring

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

Timeframe: 10 years

Urine osmolarity as a measure of appropriate dosing

Timeframe: 10 years

Evaluation of rate of drug discontinuation and average Duration of therapy

Timeframe: 10 years

Trial details

NCT IDNCT02497521

SponsorUniversity of Cologne

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12

Contact for this trial

Roman-Ulrich Mueller, MD

+49(0)22147897222 roman-ulrich.mueller@uk-koeln.de

View on ClinicalTrials.gov More ADPKD (Autosomal Dominant Polycystic Kidney Disease) trials