An observational study in ADPKD (Autosomal Dominant Polycystic Kidney Disease), sponsored by University of Cologne. Recruiting at 12 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by University of Cologne · Observational
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.
A substantial number of ADPKD patients treated in our center or referred to our center for counseling are considered eligible for tolvaptan treatment and, thus, will be invited to enter the registry. Furthermore, many patients with ADPKD are treated by nephrologists in practices. We operate a network with many of these practices and will expand this network. Patients can be enrolled - after having obtained approval by the local ethics committee - at external sites (expected number: about 500 patients per year). We are also closely liaised with the German self-help group PKDCure (PKD Familiaere Zystennieren e.V.), which is dedicated to ADPKD-linked research. Recruitment of patients will be facilitated by intensified interacting with these groups. Usually, patients that are referred to our institution for evaluation or counseling are regularly seen once a year. No additional trial-related visits in our institution will be required which is in line with the observational nature of the trial. However, data recording is not restricted to parameters assessed at our center but does include also parameters assessed by the treating physician.
SOPs (Standard Operating Procedures) that include further diagnostic tests like MRI are applied routinely in ADPKD patient management in our institution. The data obtained from these tests will be entered in the registry.
At enrolment, clinical, laboratory data and imaging study findings are collected after obtaining informed consent. The parameters listed below constitute the core data set, additional parameters can be included if considered essential.
Clinical data:
Laboratory parameters include primarily (but not exclusively):
Imaging study parameters:
Registered patients will be provided with diaries for documentation of tolvaptan dose, adverse side effects etc. These diaries are collected on a yearly basis and the data are included in the registry. Additionally the patients will be asked to fill in a questionnaire regarding the current medication, complications of ADPKD etc. once a year as well as a commercially available SF-12 (quality of life assessment) form.
Data capture will be done at yearly intervals starting at 12 months after enrolment. It includes the biochemical parameters and imaging study findings that have been obtained over the precedent 12 months.
The following additional data will be obtained:
According to the observational character of this study, no additional blood samples, examinations or imaging studies are required per protocol.
185 studies on the registry are indexed under Polycystic Kidney, Autosomal Dominant; 42 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 150 across 45 observational studies indexed under Polycystic Kidney, Autosomal Dominant.
Browse Polycystic Kidney, Autosomal Dominant studies →University of Cologne is the lead sponsor of 203 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with diagnosis of ADPKD and therapy with tolvaptan
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with diagnosis of ADPKD, who are either evaluated for tolvaptan treatment indication, planned for tolvaptan treatment, or are already treated with tolvaptan
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
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
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
Demographics
Data on demographics will be collected
Time frame: 10 years
Clinical and biochemical characteristics at enrolment and treatment initiation
Time frame: 10 years
Clinical and biochemical characteristics during follow-up
Time frame: 10 years
Urinary output
Time frame: 10 years
Evolution of estimated glomerular Filtration rate (eGFR) over the Observation period
Time frame: 10 years
Evolution of TKV
Time frame: 10 years
Side effects
Time frame: 10 years
Liver enzymes
Time frame: 10 years
Not enrolling at this site.
Not enrolling at this site.
Started Nov 2015 (actual). Primary completion is estimated for Dec 2027, 145 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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