Registry for patients with Autosomal Dominant Polycystic Kidney Disease treated with Tolvaptan
The German ADPKD Tolvaptan Treatment Registry is a Prospective, Observational, Multicentric Study of Patients Suffering From ADPKD That Are Considered for Tolvaptan Treatment.
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cologne Academic / other |
| Locations | 12 sites (Müllheim, Baden-Wurttemberg and 11 other locations) |
| Trial ID | NCT02497521 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown success in collecting real-world data for ADPKD treatments, making this approach both relevant and valuable.
Eligibility criteria
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 this trial is running
Müllheim, Baden-Wurttemberg and 11 other locations
- 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)
- Nieren- und Diabeteszentrum Nettetal-Lobberich — Nettetal, North Rhine-Westphalia, Germany (Active_not_recruiting)
- University Hospital of Leipzig, Nephrologische Ambulanz — Leipzig, Saxony, Germany (Recruiting)
- Praxisgemeinschaft Dr. Peschel — Leipzig, Saxony, Germany (Recruiting)
- University Hospital of Schleswig-Holstein — Lübeck, Schleswig-Holstein, Germany (Recruiting)
- Nierenzentrum Lübeck — Lübeck, Schleswig-Holstein, Germany (Recruiting)
- Charité Universitätsmedizin Berlin — Berlin, State of Berlin, Germany (Active_not_recruiting)
- University Hospital of Jena — Jena, Thuringia, Germany (Recruiting)
- Robert-Bosch-Krankenhaus — Stuttgart, Germany (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.