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Clinical trials in PKD at KUMC

Clinical trials in PKD currently ongoing at KUMC:

Observational studies

Trial name Sponsor Summary Details Status
                          
Study
coordinator
                          
PKD Biomarkers Repository Study NIH Identification of reliable biological markers of cyst growth in early stages of PKD

More at: www.kumc.edu/pkdstudy
Length: Five years
Time commitment: Two hours once per year
Procedures: MRI, blood and urine labs, and questionnaires
Eligibility: children and young adults age 35 and younger, who are diagnosed with PKD and have normal kidney function
Recruiting Cathy Creed

Debbie Griffin
KUMC PKD Repository KU Kidney Institue/PKD Foundation Collection of blood and urine from individuals with PKD are made available to investigators involved in PKD research • Length: One visit only
Time commitment: One hour or less
Procedures: Collection of blood and urine, and brief medical history questionnaire
Eligibility: age 2 - 70, diagnosed with PKD
Recruiting Cathy Creed
CRISP IV  NIH/NIDDK Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) IV: Prognosis for End-Stage Renal Disease and Biomarker Validation

Length: 4 years

· Time commitment: One in person enrollment visit- 1 hour

Four blood draws - 30 min visit to a lab

Four imes a year- 30 min visit by telephone or email

· Procedures: Blood labs, Medical history, and Questionnaires

Eligibility: Participated in the past CRISP  studies and have not reached end stage renal disease (ESRD) or participated in the HALT-PKD study

 

Active

Enrollment limited to those who were previously enrolled in CRISP study

Judy Vun
Zhuo Tang
Debbie Griffin

PKD Registry NIH Collect and store medical information in a PKD database used by investigators at KUMC to assess feasibility when developing new PKD studies and to recruit for future trials

 • Length: Indefinitely

· Time commitment: 30 min visit (may be over the phone)

· Procedures: Questionnaire

Eligibility: Diagnosed with PKD

Active and enrolling

Judy Vun
Zhuo Tang
Debbie Griffin

 

Studies involving drug therapy

Trial name Sponsor Summary Details Status
                          
Study
coordinator
                          
Otuska 211 Otsuka Open label extension study to evaluate the long term safety of Tolvaptan in patients with PKD Length: 30 months with visits every 3 months
• Time commitment: One hour each visit
Procedures: Medication, labs, and questionnaires
Eligibility: Completed and transfered from Otsuka 210, 271, or prior tolvaptan ADPKD trial
Active Debbie Griffin
PKD Hydralazine study Frontiers

Hydralazine which is an FDA approved medication, has been shown to reduce cyst growth in mice.  The study will determine if low dose Hydralazine is an effective, affordable, and safe treatment for PKD.

Length: 8 weeks
• Time commitment:   Every 2 weeks for total of 5 visits
Procedures: urine and blood labs, physical exam
Eligibility: Diagnosed with PKD, age 18 to 65yrs, with normal kidney function.

Active

Debbie Griffin

Last modified: Sep 28, 2018
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