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
Budesonide Investigator initiated Budesonide for MPA-induced diarrhea in renal transplant recipients
  • Length: 16 weeks
  • Time commitment: 5 in-office visits at 1 hour each, 2 phone calls at 15 minutes each
  • Procedures: Quality of Life, 2 questionnaires, 1 week diary symptoms
  • Eligibility: 3 months post renal transplant, experiencing side-effect of diarrhea as a result of taking Mycophenolate

Kenya Mitchell
Prismocitrate 18
Clinical Trial
Baxter Clinical evaluation of use of Prismocitrate 18 in patients undergong acute continuous renal replacement therapy (CRRT)
  • Length: 35 days
  • Time commitment: 5 days of study CRRT, 30 days of follow-up done by telephone
  • Procedures: Treatment with study CRRT up to 120 hours post randomization. Control group will be AKI patient receiving CRRT with no anticoagulation.
  • Eligibility: Age 18 or older with acute kidney injury requiring treatment with CRRT.

Judy Vun
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  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
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 0-35, with early stage PKD, normal kidney function, family history of PKD, individuals without PKD diagnosis may also participate
Cathy Creed
Zhuo Tang
Judy Vun
PKD Registry NIH Collect and store medical information in a PKD database used by investigators of 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
Zhuo Tang
Judy Vun
Cathy Creed
Debbie Griffin
Calciprotein Isolation in ESRD NIH Analyze both the amount and characteristics of calciproteins in the blood and identify new ways to isolate calciproteins
  • Length: 1 visit only
  • Time commitment: Approximately 10 minutes
  • Procedures: One-time blood draw
  • Eligibility: Diagnosed with ESRD
Judy Vun
CRISP IV University of Pittsburgh
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
  • Two blood draws - 30-minute visit to a lab
  • Three times a year - 30-minute telephone visit
  • 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
Judy Vun
Zhuo Tang
Debbie Griffin
Fabry Registry Genzyme Collection of clinical data on patients with Fabry disease around the world in an effort to help health professionals involved in treatment or diagnosis better understand Fabry Disease and its management
  • Length: Indefinitely
  • Time commitment: Data will be obtained from medical record. 30 minutes or less phone call if additional information needed
  • Procedures: Questionnaires
  • Eligibility: Diagnosed with Fabry Disease
Debbie Griffin

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
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) Zhuo Tang


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
Zhuo Tang, MD, MS                (913) 588-3985      ztang2@kumc.edu
Judy Vun, LPN                        (913) 588-8983      jvun@kumc.edu 

Last modified: Aug 11, 2017
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