Clinical Trials

The following clinical trials are currently recruiting participants. If you would like more information regarding the trial or how to participate, please contact the study coordinator.

Trial Name

Sponsor Summary Details Study Coordinator
PKD Repository PKD Foundation Biorepository (biobank) of blood and urine which will be used by investigators involved in multiple research studies to further our understanding of PKD  Length: 1 visit only
· Time commitment: 1 hour or less • Procedures: Collection of blood and urine, and brief medical history questionnaire
 Eligibility: age 2 - 70, diagnosed with PKD
Cathy Creed or Judy Vun
Exercise Frontiers: Heartland Institute for Clinical and Translation Research Determine the effect of 12 weeks of structured aerobic exercise on memory and thinking in patients on dialysis • Length: 12-26 weeks
 Time commitment: 4-5 visits to complete assessments and 24 visits for exercise sessions
• Procedures: Exercise assessments and program, memory assessment, collection of blood, medical history, and questionnaires
 Eligibility: age 20 or over and on dialysis with reliable means of transportation
Judy Vun
Cognitive Impairment KUMC Kidney Institute Evaluation of the changes in memory and thinking before and after transplant in relation to changes seen in images of the brain · Length: 1-2 years                           • Time commitment: 1-2 visits pre-transplant, and 2 visits prost-transplant to complete assessments
• Procedures: Memory assessments, brain MRI, collection of blood and urine, medical history, and questionnaires
• Eligibility: age 25-70, pre-transplant ESRD patients listed for renal transplantation at KU
Kenya Mitchell
NIAC-PKD-2 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: 1 year
·Time commitment: 4 visits over 1 year, approximately 2 hours per visit ·Procedures: MRI's, labs, and questionnaires   · Eligibility: age 18 - 60, GFR > 50
Cathy Creed
Biomarkers CORE NIH Identification of reliable biological markers of cyst growth in early stages of PKD ·Length: 5 years
·Time commitment:  Two hours once per year ·Procedures: MRI, blood and urine labs, and questionnaires                        ·Eligibility: age 2-50 with early stage PKD, normal kidney function, family history of PKD, individuals without PKD diagnosis may also participate
Cathy Creed
Rifaximin KUMC Kidney Institute Impact of Rifaximin therapy on intestinal byproducts in chronic kidney disease • Length: 2 weeks 
· Time commitment: 2 visits  · Procedures: Medication, labs, medical history                                               • Eligibility: age 18 or older, Stage IV-V chronic kidney disease
Judy Vun

The following clinical trials are active and NOT currently recruiting participants. If you would like more information regarding the trial, please contact the study coordinator.

Trial Name Sponsor Summary Study Coordinator
Vasculitis ChemoCentryx Phase 2 Study evalute the safety and efficacy of CCX168 in subjects with anit-neutrophil cytoplasmic antibody (ANCA)-associated vasulitis (AAV). Dawn Lockhart
Tolvaptan Otsuka Tolvaptan is being studied as a possible treatment for ADPKD. ADPKD is a disease that causes kidney cysts (cysts are like fluid-filled balloons), worsening kidney function, blood in the urine, kidney pain, high blood pressure, kidney stones, kidney infections, and cysts in the liver or other parts of the body. Debbie Griffin
CRISP III NIH Efficacy of Magnetic Resonance Imaging (MRI) can detect changes in kidney size. Debbie Griffin or Judy Vun
Ret-D-001 Retrophin Efficacy and safety of Sparsentan (Re-021), a dual endothelin receptor and angiotensin receptro blocker, in patients with focal segmental glomerulosclerosis (FSGS) Tyler Polshak
Modifier NIH/Mayo Identification of genetic factors that influence the severity of PKD in individuals and families by collection of blood for DNA isolation Cathy Creed
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  Debbie Griffin
Otuska 211 Otsuka Open label extension study to evaluate the long term safety of Tolvaptan in patients with PKD Debbie Griffin
CRISP III NIH Evaluation of the accuracy and validity of MRIs to determine disease progression in PKD Judy Vun
KD019 ADPKD Kadmon A phase 2a study is aimed at determining the safety, tolerability and effectiveness of KD019 in slowing the progression of PKD.  Cathy Creed
NIAC-PKD1
Frontiers: Heartland Institute for Clinical and Translational Research 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 Cathy Creed
TEMPO 4(271) Otsuka Multi-center, open-label, extension study to evaluate the long-term efficacy and safety of oral tolvaptan tablet regimens in subjects with autosomal dominant polycystic kidney disease Debbie Griffin
PRX-102 Protalix An extension of phase 1/2, open label, dose ranging study to evaluate the safety, tolerability, pharmacokinetics and exploratory efficacy parameters of PRX-102 administered by intravenous infusion every 2 weeks for 12 weeks to adult Fabry patients Cathy Creed
Mentor NIH Membranous nephropathy trial of rituximab vs cyclosporine in the treatment of idiopathic membranous nephropathy (IMN) Tyler Polshak

Study Coordinator Contact Information
Cathy Creed, RN                     (913) 588-0053       ccreed@kumc.edu
Debbie Griffin, RN, CDE          (913) 588-7691       dgriffin3@kumc.edu
Kenya Mitchell, BA, CCRP       (913) 945-7946      kmitchell5@kumc.edu
Judy Vun, LPN                        (913) 588-8983       jvun@kumc.edu 

Last modified: May 26, 2016
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