The German ADPKD Tolvaptan Treatment Registry

  • STATUS
    Recruiting
  • End date
    Dec 15, 2027
  • participants needed
    500
  • sponsor
    University of Cologne
Updated on 15 February 2021

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.

Description

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:

  • demographic data (sex, age, height, weight)
  • family history
  • genotype (if available)
  • extrarenal ADPKD manifestations
  • co-morbidities
  • medication
  • physical examination
  • blood pressure
  • no. of extrarenal and renal complications in the past 12 months (urinary tract infections, pain episodes, macrohematuria, kidney stones, hospital admissions, ...)

Laboratory parameters include primarily (but not exclusively):

  • serum sodium
  • serum potassium
  • serum osmolality
  • serum creatinine
  • estimated glomerular filtration rate (eGFR)
  • serum urea
  • serum uric acid
  • whole blood count
  • liver enzymes, bilirubin
  • urinary sodium (spot and 24h-urine)
  • urinary potassium
  • urinary osmolality
  • urinary creatinine
  • urinary urea
  • urinary uric acid
  • urinary protein

Imaging study parameters:

  • MRI - TKV (Total Kidney Volume)
  • ultrasound
  • (CT-scan if available)

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:

  • prescribed tolvaptan dose within the precedent 12 months
  • maximum dose of tolvaptan given in the precedent 12 months
  • weight, blood pressure
  • urine output
  • adverse effects
  • hospital admissions
  • occurrence of kidney pain, haematuria, or urinary tract infection
  • complications associated with extrarenal manifestations of ADPKD
  • data from diaries and questionnaires as mentioned above

According to the observational character of this study, no additional blood samples, examinations or imaging studies are required per protocol.

Details
Condition Polycystic Kidney, Autosomal Dominant, autosomal dominant polycystic kidney disease
Clinical Study IdentifierNCT02497521
SponsorUniversity of Cologne
Last Modified on15 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Polycystic Kidney, Autosomal Dominant?
Do you have any of these conditions: autosomal dominant polycystic kidney disease or Polycystic Kidney, Autosomal Dominant?
Do you have any of these conditions: autosomal dominant polycystic kidney disease or Polycystic Kidney, Autosomal Dominant?
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note