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The German ADPKD Tolvaptan Treatment Registry (AD(H)PKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02497521
Recruitment Status : Recruiting
First Posted : July 14, 2015
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Thomas Benzing, University Hospital of Cologne

Brief 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.

Condition or disease
ADPKD (Autosomal Dominant Polycystic Kidney Disease)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
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.
Actual Study Start Date : November 2015
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Tolvaptan

Group/Cohort
ADPKD
Patients with diagnosis of ADPKD, who are either evaluated for tolvaptan treatment indication, planned for tolvaptan treatment, or are already treated with tolvaptan



Primary Outcome Measures :
  1. Drug dosing and titration as a measure of changes in real-life setting [ Time Frame: 10 years ]
    Drug dosing and titration as a measure of maximum dose and the final dose and how fast it is achieved

  2. Urine osmolarity as a measure of appropriate dosing [ Time Frame: 10 years ]
    Data on urine osmolarity will be collected to measure appropriate dosing to provide the desired protective effect

  3. Evaluation of rate of drug discontinuation and average Duration of therapy [ Time Frame: 10 years ]
    Evaluation of rate of drug discontinuation and average Duration of therapy


Secondary Outcome Measures :
  1. Demographics [ Time Frame: 10 years ]
    Data on demographics will be collected

  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 ]
  5. Evolution of estimated glomerular Filtration rate (eGFR) over the Observation period [ Time Frame: 10 years ]
  6. Evolution of TKV [ Time Frame: 10 years ]
  7. Side effects [ Time Frame: 10 years ]
  8. Liver enzymes [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with diagnosis of ADPKD and therapy with tolvaptan
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"

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497521


Contacts
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Contact: Roman-Ulrich Mueller, MD +49(0)22147897222 roman-ulrich.mueller@uk-koeln.de
Contact: Cornelia Boehme +49(0)22147897222 studienzentrum-medII@uk-koeln.de

Locations
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Germany
Fachinternistische Gemeinschaftspraxis Markgraeferland Recruiting
Müllheim, Baden-Wuerttemberg, Germany, 79379
Contact: Markus Cybulla, MD         
Contact: Gudrun Tech         
Principal Investigator: Markus Cybulla, MD         
University Hospital of Wuerzburg, ZIM Recruiting
Wuerzburg, Bayern, Germany, 97080
Contact: Daniel Kraus, MD         
Contact: Kirsten Hofmann         
Principal Investigator: Christoph Wanner, MD         
Sub-Investigator: Daniel Kraus, MD         
Medizinische Hochschule Hannover Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Roland Schmitt, MD         
Contact: Hermann Haller, MD         
Principal Investigator: Roland Schmitt, MD         
Sub-Investigator: Hermann Haller, MD         
University Hospital of Cologne Recruiting
Cologne, Nordrhein-Westfalen, Germany, 50937
Contact: Thomas Benzing, MD    +49 221 478 97222    thomas.benzing@uk-koeln.de   
Contact: Roman-Ulrich Mueller, MD    +49 221 478 97222    roman-ulrich.mueller@uk-koeln.de   
Sub-Investigator: Roman-Ulrich Mueller, MD         
Sub-Investigator: Franziska Grundmann, MD         
Sub-Investigator: Katharina Burkert, MD         
Sub-Investigator: Polina Todorova         
Sub-Investigator: Victor Suarez, MD         
Principal Investigator: Thomas Benzing, MD         
Nieren- und Diabeteszentrum Nettetal-Lobberich Active, not recruiting
Nettetal, Nordrhein-Westfalen, Germany, 41334
University Hospital of Leipzig, Nephrologische Ambulanz Recruiting
Leipzig, Sachsen, Germany, 04103
Contact: Jan Halbritter, MD         
Principal Investigator: Jan Halbritter, MD         
Praxisgemeinschaft Dr. Peschel Recruiting
Leipzig, Sachsen, Germany, 04107
Contact: Katrin Peschel, MD         
Principal Investigator: Katrin Peschel, MD         
University Hospital of Schleswig-Holstein Recruiting
Lubeck, Schleswig-Holstein, Germany, 23538
Contact: Figen Cakiroglu, MD         
Contact: Alexandra Tiedtke         
Principal Investigator: Figen Cakiroglu, MD         
Nierenzentrum Lübeck Recruiting
Lübeck, Schleswig-Holstein, Germany, 23562
Contact: Peter Gerke, MD         
Contact: Lutz Hennings         
Principal Investigator: Peter Gerke, MD         
University Hospital of Jena Recruiting
Jena, Thueringen, Germany, 07747
Contact: Martin Busch, MD         
Principal Investigator: Martin Busch, MD         
Charité Universitätsmedizin Berlin Active, not recruiting
Berlin, Germany, 10117
Robert-Bosch-Krankenhaus Recruiting
Stuttgart, Germany, 70376
Contact: Dominik Alscher, MD         
Contact: David Callau Monje, MD         
Principal Investigator: Dominik Alscher, MD         
Sub-Investigator: David Callau Monje, MD         
Sponsors and Collaborators
University of Cologne
Investigators
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Principal Investigator: Thomas Benzing, MD, Prof. University Hospital of Cologne
Additional Information:
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Responsible Party: Prof. Dr. med. Thomas Benzing, MD, University Hospital of Cologne
ClinicalTrials.gov Identifier: NCT02497521    
Other Study ID Numbers: 003
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Keywords provided by Prof. Dr. med. Thomas Benzing, University Hospital of Cologne:
polycystic kidney disease
autosomal dominant polycystic kidney disease
ADPKD
Tolvaptan
Jinarc
Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Congenital Abnormalities
Kidney Diseases, Cystic
Abnormalities, Multiple
Ciliopathies
Genetic Diseases, Inborn