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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
PHOENIX Reata A multi-center, open-label phase II trial of the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with rare chronic kidney diseases (CKD): CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD).
  • Length: 16 weeks
  • Time commitment: Total of 8-10 clinic visits. Screening visit approximately 4.5 hours. All other visit 1.5- 2 hours.
  • Procedures: Medical history, questionnaires, clinical global impression, physical exam, ECG, ECHO, collection of blood and urine, receiving and returning study drug.     
  • Eligibility: age 18 - 65 years, diagnosed with T1D, IgAN, FSGS and ADPKD. 
  • Note: Enrollment of ADPKD patients is currently closed

Cathy Creed
Zhuo Tang

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

Erin Delaney
Erin Duewel

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
Erin Delaney
Erin Duewel
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
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
Renal Tubular Function in Living Donors Investigator initiated Evaluate the renal tubular function pre- and post-nephrectomy in living donors.
  • The study will help to better understand the long-term effects of loss of nephrons on tubular function and injury in otherwise healthy humans. This will be a prospective trial where living donors will have renal function and tubular function checked before nephrectomy and at one year post-nephrectomy.
Erin Delaney
Erin Duewel
Monofer Pharmacosmos A phase III, randomized, open-label, comparative safety and efficacy trial of intravenous iron isomaltoside (Monofer) and iron sucrose in subjects with iron deficiency anemia and non-dialiysis-dependent chronic kidney disease.
  • Length: Approximately 10 weeks
  • Time commitment: Total of 6-8 visits. First visit approximately 4 hours. All other visits 2-3 hours.
  • Procedures: Treatment with study drug - intravenous administration of an iron solution, physical exam, medical history questionnaires, blood draw, ECG
  • Eligibility: age 18 or older, diagnosed with iron deficiency anemia, diagnosed with chronic kidney disease (non-dialysis-dependent)
Judy Vun
Cognitive Function-Everolimus Novartis, llT Title: Alterations in Cognitive Function and Cerebral Blood Flow after Conversion from Calcineurin Inhibitors to Everolimus. This single center longitudinal 12 weeks observational study will determine whether conversion from calcineurin inhibitor (Tacrolimus) to an mTOR inhibitor, Everolimus, is associated with improvement in cognition and cerebral blood flow. 
  • Goal: Enroll 20 kidney transplant recipients who will undergo conversion and 10 matched controls at the University of Kansas Medical Center.
Erin Delaney
Erin Duewel

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).
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
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
Erin Delaney, RN                   (913) 588-3520
Erin Duewel                          (913) 588-3520
Debbie Griffin, RN, CDE         (913) 588-7691
Zhuo Tang, MD, MS                (913) 588-3985
Judy Vun, LPN                        (913) 588-8983 

Last modified: Sep 28, 2018