Clinical trials in PKD at KUMC

Clinical trials in PKD currently ongoing at KUMC:

Observational studies

Trial name Sponsor Summary Details Status
                          
Study
coordinator
                          
Modifier NIH/Mayo Identification of genetic factors that influence the severity of PKD in individuals and families by collection of blood for DNA isolation Length: One visit only
Time commitment: One hour
Procedures: Blood draw, questionnaire, optional MRI
Eligibility: Confirmed diagnosis of PKD. Patients who have received a transplant or started  dialysis are also eligible
Recruiting Cathy Creed
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: age 7-35 with early stage PKD,
normal kidney function, family history of PKD, individuals without PKD diagnosis may also participate
Recruiting Cathy Creed

Debbie Griffin
KUMC PKD Repository KU Kidney Institue/PKD Foundation Biorepository (biobank) of blood and urine which will be used by investigators involved in multiple research studiesto further our understanding of PKD

• 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 III NIH Evaluation of the accuracy and validity of MRIs to determine disease progression in PKD Length: 4 years - one visit per year
Procedures: Blood and urine collection, medical history, questionnaires, and MRI
Eligibility: Completion of CRISP I study
Active Judy Vun

 

Studies involving drug therapy

Trial name Sponsor Summary Details Status
                          
Study
coordinator
                          
NIAC-PKD2
                    
 
NIH                      A phase 2b study comparing the efficacy of high dose niacinamide (the main component of vitamin B3) to placebo in slowing the progression of PKD
                               
Watch a short video to learn more about this study                                     
Length: One year
Time commitment: 4 visits over one year - approximately 2 hours per visit
Procedures:  MRIs, labs, and questionnaires
Eligibility: age 18 - 60, GFR > 50
Recruiting Cathy Creed
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
REPRISE Otsuka A phase III study comparing the efficacy of Tolvaptan to placebo in changing the rate of decline of kidney function in PKD patients with late stage chronic kidney disease · Length: 15 months
· Time commitment: One hour each month                                       
· Procedures: Medication, labs, and monthly visits to KUMC
Eligibility: age 18 to 66, have never taken Tolvaptan, GFR above 25 but below 65
Active Debbie Griffin
KD019 ADPKD

Kadmon

A phase 2a study is aimed at determining the safety, tolerability and effectiveness of KD019 in slowing the progression of PKD.

Length: 24 months - 7 preliminary visits within the first month and then visits every month for 23 months
Procedures: Medication, labs, MRI, ECG, and echocardiogram
Eligibility: GFR > 50
Active

Cathy Creed

NIAC-PKD1
Frontiers

A pilot and feasability study of administering niacinamide (the main component of vitamin B3) to patients with PKD and preliminary exploration of its use to slow the progression of PKD Length: One year
Time commitment: 4 visits over one year - approximately 2 hours per visit
Procedures:  MRIs and labs
Eligibility: a confirmed diagnosis of PKD and normal kidney function GFR > 60
Active

Cathy Creed
Last modified: Jul 14, 2016
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