ADPKD patients only

San Antonio-Texas

RE3877-0008

ICON Early Phase Services is conducting a research study for adults ages 18-70 diagnosed with Autosomal Dominant Polycystic Kidney Disease (ADPKD). This study is being done to gain more information on a potential treatment for ADPKD.  The study drugs will be administered as an injection under the skin.  

Vital signs, ECGs, physical examinations and pregnancy tests will be performed. Blood and urine samples will also be obtained during this study.  If needed, an MRI may be performed on a different day than your initial screening visit. 


Participants will complete:


• 1 screening visit
• Up to 2  overnights ( not consecutive)
• 3 outpatient visits ( up to at least 6 hours on site)


To determine if you fully qualify, it will be necessary to obtain blood and urine samples – no fasting required.  If ICON does not have your medical records on file, you will need to provide medical records at screening. 

For more information, see below.

Qualified participants may be compensated up to $1100 for time and travel.

If you are able to answer “YES” to the following statements, you may qualify for this study.


• I am an adult with ADPKD, 18 to 70 years old


• My body mass index is between 18 and 35  kg/m2  


• I have not participated in an investigational interventional study within 28 days  (or 5 times the half-life of the drug, whichever is longer) before Day 1 of the study 


• If Female, I am not capable of becoming pregnant.  I have been postmenopausal for at least 1 year or I am surgically sterile (ovaries and uterus removed, ovaries removed, bilateral tubal ligation/occlusion). Sterilization procedures must have occurred at least 6 months prior to the first dose


• If female, I am able to become pregnant and agree to use a highly effective method of contraception from screening through 28 days after the last dose of study drug 

 
• If Male, I agree to use a condom during heterosexual intercourse from screening through 28 days after the last dose of study drug 


• If Male, I agree not to donate sperm during the study and for 90 days after the last dose of study drug   


• I am able to communicate effectively in English with the study personnel 


• I do not have a history of drug or alcohol abuse in the past year


• I do not currently have a urinary tract infection 

 
• I do not Hepatitis B, C or HIV


• I have 2 kidneys and have not received a kidney transplant


• I do have a recent history of drug or alcohol abuse within the past year


• I have not recently received blood/blood products, or donated blood or plasma or had a significant blood loss


• I do not have a tattoo, scarring or any other condition on the abdomen 

 

It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the study screening procedures.  Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit.  

No guarantees can be made regarding group assignments for any particular study.  ICON will not assume any liability for lost time, travel or failure to qualify.


Be sure to bring all of your medications with you to your screening appointment.  

 

Please note, you need to bring a valid, non-expired photo ID with you when you attend your screening visit.  We accept a government issued identification card such as a driver's license, state issued ID card, military ID or passport.  You will be required to show this same photo ID at all study visits.

 

You will be filling out paperwork for the study.  Please arrive at least 30 minutes in advance of your screening appointment.  If you are late for your appointment you may not be seen or may need to reschedule.  

 

Be advised that you will need to provide medical records as part of the screening process for this study.  If possible, please bring your full medical records with you to your screening appointment.  If you cannot bring your records with you, you must provide them before you can be admitted into the study.  Note that full medical records include surgical reports.  You will not be allowed to participate in the study without medical records defined as:


• All medical records, including but not limited to: office notes, face sheets, history and physical, consultation notes, inpatient, outpatient and emergency room treatment, all clinical charts, reports, surgical reports, order sheets, progress notes, nurse's notes, social worker records, clinic records, treatment plans, admission records, discharge summaries, reports of consultations, documents, correspondence, test results, statements, questionnaires/histories, from your medical provider(s). 
• For females, surgical reports are required as documentation for procedures such as hysterectomy, bilateral oophorectomy and tubal ligation.  

 


If you are able to answer “YES” to the above questions and would like to make an appointment online please click on the following link:

For more information and to schedule an appointment, please call our Recruitment Department at 210-225-5437.

 

STUDY DATES - Note: Individual dates will be determined for qualified subjects.

 

 

Notice:

In order to schedule a screening appointment online, you will be required to enter your personal information (name, date of birth, etc.) into a secure, password protected database.  Your information will remain confidential and will not be accessible by any party that does not work directly for ICON Early Phase Services.  It may be necessary for the recruitment staff to contact you by phone in the event of a schedule change or if more information is needed.  You have the right to remove your information from the database at any time by logging in to the scheduling program and choosing “My Profile” and then selecting the “Terminate Account” button.   

PURSUANT TO SECTION 30.06, 
PENAL CODE (TRESPASS BY HOLDER OF A LICENSE TO CARRY A CONCEALED HANDGUN) 
A PERSON LICENSED UNDER SUBCHAPTER H, CHAPTER 411, GOVERNMENT CODE (CONCEALED HANDGUN LAW), MAY NOT ENTER THIS PROPERTY WITH A CONCEALED HANDGUN.

Reference
RE3877-0008
Name
RE3877-0008
Details
Now screening for participants diagnosed with Autosomal Dominant Polycystic Kidney Disease (ADPKD)s. Call for more information and to make an appointment.
Gender
Male or Female
Payment amount
Up to $1,100
Age
18 - 70