Registry for patients with Autosomal Dominant Polycystic Kidney Disease treated with Tolvaptan
Official title: The German ADPKD Tolvaptan Treatment Registry is a Prospective, Observational, Multicentric Study of Patients Suffering From ADPKD That Are Considered for Tolvaptan Treatment.
Run by University of Cologne · NCT02497521 · Data updated 2026-11-12
This study is collecting information from patients with Autosomal Dominant Polycystic Kidney Disease who are being treated with Tolvaptan to see how well the treatment works in real life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | University of Cologne Academic / other |
| Locations | 12 sites (Müllheim, Baden-Wurttemberg and 11 other locations) |
| Status | Recruiting |
| Started | November 2015 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT02497521 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this registry are adults over 18 years old with a confirmed diagnosis of ADPKD who are being evaluated for or are currently receiving Tolvaptan treatment.
✕Probably not a fit
Patients who are not capable of giving informed consent or those with end-stage renal disease requiring renal replacement therapy will not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The German ADPKD Tolvaptan Treatment Registry is a prospective, observational study that collects real-world data on patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) who are being considered for or are currently receiving treatment with Tolvaptan. Patients are enrolled from various centers and practices, allowing for a comprehensive understanding of treatment management across different settings. Clinical, laboratory, and imaging data are collected after obtaining informed consent, and the study aims to facilitate better treatment strategies for ADPKD patients. The registry will also collaborate with patient advocacy groups to enhance recruitment and data collection.
Why it matters
Potential benefit: If successful, this registry could improve treatment management and outcomes for patients with ADPKD receiving Tolvaptan.
How similar studies have gone: Other studies have shown success in collecting real-world data for ADPKD treatments, making this approach both relevant and valuable.
Who can join: the full rules
Show full inclusion / exclusion criteria
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"
Where it's running
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Fachinternistische Gemeinschaftspraxis Markgraeferland
Müllheim, Baden-Wurttemberg, Germany Recruiting -
University Hospital of Wuerzburg, ZIM
Würzburg, Bavaria, Germany Recruiting -
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany Recruiting -
University Hospital of Cologne
Cologne, North Rhine-Westphalia, Germany Recruiting -
University Hospital of Leipzig, Nephrologische Ambulanz
Leipzig, Saxony, Germany Recruiting -
Praxisgemeinschaft Dr. Peschel
Leipzig, Saxony, Germany Recruiting
Show 6 more locations
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University Hospital of Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany Recruiting -
Nierenzentrum Lübeck
Lübeck, Schleswig-Holstein, Germany Recruiting -
University Hospital of Jena
Jena, Thuringia, Germany Recruiting -
Robert-Bosch-Krankenhaus
Stuttgart, Germany Recruiting -
Nieren- und Diabeteszentrum Nettetal-Lobberich
Nettetal, North Rhine-Westphalia, Germany Active not recruiting -
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, Germany Active not recruiting
Study contacts
- Principal investigator: Thomas Benzing, MD, Prof. — University Hospital of Cologne
- Study coordinator: Roman-Ulrich Mueller, MD
- Email: roman-ulrich.mueller@uk-koeln.de
- Phone: +49(0)22147897222
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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GV-100 first-in-human dose study in healthy adults
This early-stage study tests how GV-100 behaves and is tolerated in healthy adults to see how it might be used in people with ADPKD in the future.
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Bempedoic Acid Therapy for ADPKD
This study tests whether bempedoic acid can help people with autosomal dominant polycystic kidney disease by slowing the progression of their kidney disease.
-
JMKX003142 for rapidly progressive ADPKD
This Phase 2 trial will test whether the oral medicine JMKX003142 is safe, well tolerated, and can slow disease progression in adults aged 18–55 with rapidly progressive ADPKD.
-
Decision-making support for choosing treatment in kidney disease
This study is testing a new mobile app that helps patients with a specific type of kidney disease make better treatment choices about a medication called tolvaptan.
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VX-407 pharmacokinetics after a single dose in adults with ADPKD
This study tests how VX-407 is absorbed, distributed, metabolized, and excreted after a one-time oral dose in adults with polycystic kidney disease.
-
How VX-407 interacts with common birth control pills
This study tests whether VX-407 affects how birth control pills work in people with ADPKD.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.