Clinical Trials

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

Trial name Sponsor Summary Details 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: 1 visit only
Time commitment: 1 hour
Procedures: Blood draw, questionnaire, optional MRI
Eligibility: Confirmed diagnosis of PKD. Patients who have received a transplant or started  dialysis are also eligible
Cathy Creed
PKD 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
KUMC PKD Repository KU Kidney Institue/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

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: 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

Exercise Frontiers: Heartland Institute for Clinical and Translational 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 menas of transportation
Tyler Polshak
Cognitive Impairment in ESRD 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
Tyler Polshak
Rifaximin 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
CL003-168 - vasculitis ChemoCentryx Phase 2 study to evaluate the safety and efficacy of CCX168 in subjects with anit-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Length: 2 years
Time commitment: 15 visits
Procedures: Medication, labs, medical history
Eligibility: age 18 and older, new or relapsed AAV, GFR > 20
Dawn Lockhart
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) Length: 1 year
Time commitment: 10 visits
Procedures: Medication, labs, medical history
Eligibility: age 8 to 65, biopsy-proven primary FSGS, GFR > 30
Nancy Morgan

 

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

Trial name Sponsor Summary Details Study coordinator
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: 1 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
Debbie Griffin

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: 1 hour each visit
Procedures: Medication, labs, medical history, and questionnaires
Eligibility: Completed and transfered from Otsuka 210, 271, or prior tolvaptan ADPKD trial
Debbie Griffin
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
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.

•  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
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 •  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
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 •  Length: 2-5 years
•  Procedures:  Medication, labs, MRIs, medical history, questionnaires
•  Eligibility: age 18 and older, sucessful completion of a previous tolvaptan trial, confirmed diagnosis of PKD, GFR > 30
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 •  Length: 38 weeks
•  Time commitment: Visits every 2 weeks
•  Procedures: IV infusions, labs, medical history and questionnaires, MRIs, kidney biopsy
•  Eligibility: age 18 and older, completion of phase 1/2 study PB-102-F01
Cathy Creed
Mentor NIH Membranous nephropathy trial of rituximab vs cyclosporine in the treatment of idiopathic membranous nephropathy (IMN) •  Length: 1-2 years
•  Time commitment: up to 13 visits
•  Procedures: Medication, labs, medical history, questionnaires
•  Eligibility: age 18 - 80, IMN with diagnostic biopsy, GFR > 40
Nancy Morgan       

Study coordinator contact information
Debbie Griffin, RN    (913) 588-7691       dgriffin3@kumc.edu
Cathy Creed, RN     (913) 588-0053       ccreed@kumc.edu
Judy Vun, LPN        (913) 588-8983       jvun@kumc.edu
Tyler Polshak, MS   (913) 588-7609       tpolshak@kumc.edu

Last modified: Jun 03, 2014
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