Clinical Trials

Thanks to research funded by the PKD Foundation, clinical trials are now exploring several new therapies for PKD. Patients wishing to participate or learn more will find specific information about the therapies below. To participate in a clinical trial, you will need to have a formal diagnosis of PKD. To learn more, click here.


You can also learn about potential treatmentsPKD and heart disease and the Accelerating Clinical Trials (ACT) program.

Updated: 09/12/2014

Active, Recruiting

Observational Phase I Phase II Phase III Phase IV
ADPKD Pain Study    
Clinical and Molecular Description of PKD1 and PKD2 Mutation Negative Carriers in ADPKD (GeneQuest)        
Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP II)        
Core A: The Hepato/Renal Fibrocystic Diseases Translational Resource        
Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney Disease  
Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to ADPKD (REPRISE)  
The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease (PKD) Transplanted Recipients (EVERKYSTE)  
Evaluation of Gut Bacteria in Patients With Polycystic Kidney Disease        
Everolimus on CKD Progression in ADPKD  
Lanreotide in Polycystic Kidney Disease Study (LIPS)  
Mesenchymal Stem Cell Transplantation in Patients with Chronic Renal Failure Due to Polycystic Kidney Disease (PKD)      
Open-Label Tolvaptan Study in Subjects With ADPKD  
Pasireotide LAR in Severe Polycystic Liver Disease (SOM230)    
PKD Clinical and Translational Core Study (PKD Core)        
Pulsed Oral Sirolimus in ADPKD - The Vienna RAP Study  
Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control (RAFALE)    
A Safety, Pharmacokinetic and Dose-Escalation Study of KD019 in Subjects With ADPKD    
Sirolimus for Massive Polycystic Liver (SILVER)  
Somatostatin in Patients with ADPKD and Moderate to Severe Renal Insufficiency (ALADIN 2)  
Study of Lanreotide to Treat Polycystic Kidney Disease (DIPAK1)  
Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)  
Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide (Vitamin B3) in Polycystic Kidney Disease (NIAC-PKD1)    
Ursodeoxycholic Acid as Treatment for Polycystic Liver Disease (CURSOR)    

 

ADPKD Pain Study

 

Interventional

Procedure: Videothoracoscopic Splanchnicectomy (VSPL)

Sponsor:

Mayo Clinic

Study Phase:

II

Status:

Recruiting

Age Group:

18 and older

Enrollment goal:

20

Description:

Some patients with autosomal dominant polycystic kidney disease (ADPKD) have intractable disabling chronic kidney pain. Among methods used to manage these patients, removal of the nerve supply to the kidney by Videothoracoscopic excision of Splanchnic nerve (videothoracoscopic splanchnicectomy — VSPL) is one of the most promising procedures.

Contact:

Marie C. Hogan, MD, PhD, Principal Investigator (507) 266-1963 hogan.marie@mayo.edu

Website:

NIH Study Details

 

Clinical and Molecular Description of PKD1 and PKD2 Mutation Negative Carriers in ADPKD (GeneQuest)

 

Interventional

Other: Blood Collection

Sponsor:

University Hospital, Brest, France

Status:

Not yet recruiting

Age Group:

16 and older

Enrollment goal:

 1,450

Description:

  • Inclusion of ADPKD patients in 20 different centers of Nephrology in the Western part of France
  • Characterization of the Phenotype
  • Collect DNA sample
  • Analysis of PKD1 and PKD2 genes first
  • Analysis of HNFIb and UMOD for PKD1 and PKD2 negative patients
  • Recruitment of affected and non-affected relatives of PKD1 and PKD2 negative ADPKD patients
  • Identify new genes involved in ADPKD using exome sequencing in PKD1 and PKD2 negative pedigrees. 

Contact:

Emilie Cornec-Le Gall, MD 298347061 ext. +33 emilie.cornec-legall@chu-brest.fr

Website:

NIH Study Details

 

Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP II)

 

Observational

 

Sponsor:

University of Pittsburgh

Collaborators:

NIH, NIDDK

Study Phase:

Continuation of CRISP I

Status:

Enrolling by invitation only

Age Group:

15-45

Enrollment goal:

211

Description:

This study is a continuation of CRISP I to develop and implement studies to test whether imaging techniques can provide accurate and reproducible markers of disease progression in ADPKD patients.

Website:

NIH Study Details

 

Core A: The Hepato/Renal Fibrocystic Diseases Translational Resource

 

Observational

 

Sponsor:

University of Alabama at Birmingham
Collaborator: National Institutes of Diabetes and Digestive and Kidney Diseases

Status:

Recruiting

Age Group:

Up to 35 years

Enrollment goal:

200

Description:

  • To expand their comprehensive clinical database to include information from patients with hepato/renal cystic diseases.
  • To identify genetic mutations in children with ARPKD and other hepato/renal cystic diseases.
  • To establish a human tissue resource from those with hepato/renal cystic diseases for research studies.
  • To develop a comprehensive informational resource for ARPKD and other hepato/renal cystic disease Families.

Website:

NIH Study Details

 

Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney Disease

 

Interventional:

Behavioral:  Diet and Water adjustment

Sponsor:

Tufts Medical Center
Study Phase: II and III

Status:

Recruiting

Age Group:

18 to 60 years

Enrollment goal:

60

Description:

The purpose of this study is to learn if dietary habits can affect vasopressin secretion in patients with autosomal dominant polycystic kidney disease. Vasopressin increases the growth of kidney cysts and accelerates disease progression. Understanding how to control secretion of this hormone based on dietary habits may help to develop treatments to control this disease. The study will include about 60 patients from Tufts Medical Center, and will last for 2 weeks. Blood and urine tests will be done 3 times during the study period. Subjects will be randomly assigned (by chance like flipping a coin) to 1 of 2 study groups. Group 1 will be given instructions to adjust their diet. This will include adjusting the amount of water, protein, and salt intake. Group 2 will have no adjustment of diet or water. The project has tremendous public health relevance, given the large number of people affected by autosomal dominant polycystic kidney disease, and the substantial impact of the disease on morbidity, mortality, hospitalizations, dialysis or transplant, and societal costs of caring for those patients.

 Contacts:

Principal Investigator: Ron Perrone, M.D.
Sub-investigator: Osama Amro, MD (617) 636-8424 oamro@tuftsmedicalcenter.org   

 Website: NIH Study Details

 

Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease
Between Late Stage 2 to Early Stage 4 Due to ADPKD (REPRISE)

 

Intervention:

Drug: Tolvaptan (OPC-41061)
Drug: Placebo

Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Phase:

IIIb

Status:

Recruiting

Age Group:

18 years to 65 years

Enrollment goal:

1,300

Description:

The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD).

Website:

www.pkdstudy.com

 

The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease (PKD) Transplanted Recipients (EVERKYSTE)

 

Intervention:

Drug: Everolimus

Sponsor:

Assistance Publique - Hôpitaux de Paris

Study Phase:

III

Collaborator:

Novartis

Status:

Not yet recruiting

Age Group:

18 - 75

Enrollment goal:

40

Description:

Kidney graft recipients receiving a first kidney graft (between 6 months and 5 years post-transplantation) will be randomized 1:1 to receive an everolimus based immunosuppression (in association with steroids and mycophenolate mofetil) or to continue their calcineurin inhibitor-based immunosuppression regimen. The primary objective will be the reduction of total native kidney volume after a 2-year treatment period.

Contacts:

Hélène François, MD, PhD  +33(1)45 21 27 22 helene.francois@bct.aphp.fr

Website:

NIH Study Details

 

Evaluation of Gut Bacteria in Patients With Polycystic Kidney Disease

 

Observational

 

Sponsor:

Mount Sinai School of Medicine

Status:

Recruiting

Age Group:

18 years and older

Enrollment goal:

 15

Description:

To examine the impact of renal failure on the composition of gut microbiota, we are studying patients with renal failure due to polycystic kidney disease (PKD). PKD is the fourth leading cause of kidney failure, and is the most common genetic kidney disease. Compared to patients with renal failure due to diabetic nephropathy, hypertension, and glomerulonephritis, patients with PKD have virtually no major co-morbid medical conditions or associated medical interventions (i.e. antimicrobial or anti-inflammatory therapies) that could potentially alter the gut microbiota, and confound the interpretation of data.

Objectives:

  1. To compare the gut microbiota in fecal samples of PKD patients with different degrees of renal disease.
  2. To determine whether alteration in the composition of gut microbiota is linked to serum levels of metabolites and uremic solutes that are known to be associated with symptoms of uremia.

Website:

NIH Study Details

 

Everolimus on CKD Progression in ADPKD

 

Intervention:

Drug: Everolimus
Drug: Standard Therapy

Sponsor:

A. Manzoni Hospital

Study Phase:

II and III

Status:

Recruiting

Age Group:

18 and older

Enrollment goal:

90

Description:

To evaluate whether the administration of everolimus (1/5 mg/day) can slow the progression of chronic kidney disease in ADPKD patients.

Website:

NIH Study Details

 

Lanreotide in Polycystic Kidney Disease Study (LIPS)

 

Intervention:

Drugs: Lanreotide, saline

Sponsor:

Assistance Publique - Hôpitaux de Paris

Collaborator:

IPSEN pharmaceutical company, Boulogne-Billancourt, France

Study Phase:

III

Status:

Not yet recruiting

Age Group:

18 years and older

Enrollment goal:

 180

Description:

LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized double blind placebo controlled study. The main objective is to prove that lanreotide, a somatostatin analog, is able to reduce the glomerular filtration rate decline over 3 years by at least 30%. Cardiovascular outcomes, blood pressure, quality of life and safety are among the secondary outcomes. The study, which will include 180 ADPKD patients, is scheduled to start in early 2014. 

An equal number of patients with chronic kidney disease stage 2 (90 patients with GFR 89 to 60 ml/mn/1.73 m2) and chronic kidney disease stage 3 (90 patients with GFR 59 to 30 ml/mn/1.73 m2) will be included. The primary endpoint (GFR decline) will be assessed by repeated measures, in the overall population as well as in the two GFR stratus. 

Contacts:

Dominique Joly, MD, PhD 1 44 49 54 15 ext. +33 dominique.joly@nck.aphp.fr 
Laurence Lecomte, PhD  1 71 19 64 94 ext. +33 laurence.lecomte@nck.aphp.fr

 

Website:

NIH Study Details

 

Mesenchymal Stem Cell Transplantation in Patients with Chronic Renal Failure Due to Polycystic Kidney Disease (PKD)

 

Intervention:

Biological: Intravenous injection autologous mesenchymal stem cells 

Sponsor:

Royan Institute
Study Phase: I

Status:

Recruiting

Age Group:

18 to 60 years

Enrollment goal:

 6

Description:

The investigators will assess the 18-month safety and potential efficacy of autologous MSCs as therapy for ADPKD. A total of 6 patients with ADPKD IV injection of high doses 2×106 of autologous mesenchymal stem cells / kg their weight, which will be derived from biopsies of their bone marrow. Assessments will be made at 1, 3, 6, 12 and 18 months after cell injection. Changes in GFR rate were evaluated by scan isotope

Contact:

Nasser Aghdami, MD,PhD (+98) 23562000 ext 516 nasser.aghdami@royaninstitute.org 
Leila Arab, MD (+98) 23562000 ext 414 Leara91@gmail.com

Website:

NIH Study Details

 

Open-Label Tolvaptan Study in Subjects With ADPKD (TEMPO 4/4)

 

Intervention:

Drug - Tolvaptan

Sponsors:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Phase:

III

Status:

Enrolling by invitation only

Enrollment goal:

1,500

Description:

To demonstrate whether Tolvaptan modifies ADPKD progression as measured by changes from baseline in total kidney volume (TKV) and renal function.

Website:

NIH Study Details

 

Pasireotide LAR in Severe Polycystic Liver Disease (SOM230)

 

Intervention:

Drug: Pasireotide LAR

Sponsor:

Mayo Clinic
Study Phase: II

Status:

Recruiting

Age Group:

18 and older

Enrollment goal:

48

Description:

The purpose of this study is to compare SOM230 treatment to placebo in patients with severe polycystic liver disease. The investigators will also assess the effectiveness and safety of SOM230 in reducing total liver volume and improving quality of life.

Contact:

Marie Hogan, MD, PhD 507-284-2500 or hogan.marie@mayo.edu
Angela Ihrke 507-538-2902 or ihtkr.angela@mayo.org

Website:

NIH Study Details

 

PKD Clinical and Translational Core Study (PKD Core)

 

Observational

 

Sponsor:

University of Maryland
Status: Recruiting

Age Group:

18 years and older

Enrollment goal:

200

Description:

The Polycystic Kidney Disease Research Clinical and Translational Core (P30) aims to establish an infrastructure that will assist investigators in designing and conducting highest quality clinical and translational research focused on a diverse group of patients with ADPKD.

Objective 1: To establish a Mid-Atlantic cohort of ADPKD patients (N=200) with baseline clinical phenotyping performed at the General Clinical Research Unit of the University of Maryland School of Medicine.

Objective 2: To establish a state-of-the-art biobank of specimens from the ADPKD cohort including serum, plasma, urine and DNA.

Objective 3: To develop a collaborative network of physicians and practices in the Mid-Atlantic region who will contribute to the ADPKD cohort and will be willing to refer patients for future studies and trials.

Objective 4: To establish a web-based registry of ADPKD patients in the Mid-Atlantic area.

Contact:

Charalett E. Diggs, RN MSN 410-328-0207 cdiggs@medicine.umaryland.edu

Karleen Schuhart 410-328-3727 kschuhart@medicine.umaryland.edu

Website:

NIH Study Details

 

Pulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney Disease - The Vienna RAP Study

 

Interventional

Sirolimus

Sponsor:

Medical University of Vienna

Status:

Recruiting

Age Group:

18 and older

Enrollment goal:

 68

Description:

Sirolimus (SIR) has lead to a reduction of overall kidney size, a decrease in cyst density and general tubular cell proliferation in animal models, and to a reduction of the increase in creatinine and blood urea nitrogen by 34 and 39 percent respectively, as well as a reduction of cyst proliferation, expressed by a 30 percent reduction of overall kidney enlargement, a reduction in general cyst volume, and a reduction of the cyst volume density in the renal cortex in humans.

However, despite promising data from animal- and in vivo studies, most mammalian target of rapamycin inhibitor (mTOR-I) studies in patients with autosomal-dominant polycystic kidney disease (ADPKD) produced only subtle if any clinically relevant effects on cyst growth and the preservation of renal function.

In this study we will investigate if pulsed administration of SIR in a fixed weekly oral dose of 3 mg over 24 months compared to placebo significantly reduces cyst growth and preserves excretory renal function in patients with ADPKD and an estimated glomerular filtration (eGFR) rate below 60 mL/min per 1.73m2.

Contact:

Markus Riegersperger, MD 0043140400 ext 4391 markus.riegersperger@meduniwien.ac.at

Gere Sunder-Plassmann, MD 0043140400 ext 4391 gere.sunder-plassmann@meduniwien.ac.at

Website:

NIH Study Details

 

Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control (RAFALE) 

 

Intervention:

Procedure: renal sympathetic denervation; Drug: antihypertensive drugs

Sponsor:

Mei changlin, Shanghai Changzheng Hospital
Study Phase: II

Status:

Recruiting

Age Group:

20 Years to 60 Years

Enrollment goal:

100

Description:

A randomized, open-label single-center study investigates the efficacy and safety of bilateral renal artery sympathetic denervation by catheter-based radiofrequency ablation on blood pressure and disease progression control in autosomal dominant polycystic kidney disease (ADPKD).

Contact:

Changlin Mei, MD +86 21 81885391 chlmei1954@126.com

Yiyi Ma, Master +8613661679863 dukemm@126.com

Website:

NIH Study Details

 

Renal Sympathetic Denervation for Reduction of Pain and Improvement of Insulin Sensitivity in Adult Polycystic Kidney Disease

 

Interventional

Renal Denervation

Sponsor:

Odense University Hospital

Status:

Enrolling

Age Group:

18 and older

Enrollment goal:

12

Description:

In patients with polycystic kidney disease, pain may be resistant to drug therapy and may reduce quality of life. This study investigate the effect of renal denervation on this pain.

Contact:

Hans Dieperink, MD +4520598851 hans.dieperink@rsyd.dk

Marie Blicher, MD + 45 65415305 marie.blicher@rsyd.dk

Website:

NIH Study Details

 

A Safety, Pharmacokinetic and Dose-Escalation Study of KD019 in Subjects With ADPKD

 

Intervention:

Drug: KD019

Sponsor:

Kadmon Corporation, LLC
Study Phase: I & II

Status:

Recruiting

Age Group:

18 to 55

Enrollment goal:

up to 55

Description:

The primary purpose of this study is to determine the safety, tolerability and plasma pharmacokinetics of KD019 in ADPKD patients. Changes in kidney function will also be evaluated. The phase 1b portion has been completed and the best selected daily dose was determined to be 100 mg daily. The phase 2a portion of the study is now enrolling using an alternate dosing schedule of 150 mg given every Monday, Wednesday and Friday. This is a 28 day daily dosing study with an option to continue through 24 months of KD019 dosing. All participants receive active KD019 study drug. KD019 is an oral tablet that comes in 50 mg, 100 mg, and 150 mg strength tablets. Study participants will have an MRI of the abdomen at Screening and every 6 months to explore the effects of KD019. An echocardiogram will be performed at Screening, Day 26, Month 3, 6 and every 6 months thereafter.

Contact:

University of California, Los Angeles, Los Angeles, Calif., Fahad Sheckley 310.954.2692 or FSheckley@mednet.ucla.edu
University of Kansas Medical Center, Kansas City, Kan., Cathy Creed 913.588.0053 or CCREED@kumc.edu
Beth Israel Deaconess Medical Center, Boston, Mass., Alice Lee 617.667.0324 or alee16@bidmc.harvard.edu
Mayo Clinic, Rochester Minn., Lisa Bungum 507.266.4616 or Bungum.Lisa2@mayo.edu
Washington University, St. Louis, Mo., Alaina Thompson 314.362.6898 or thompsonal@wusm.wustl.edu
Cleveland Clinic, Cleveland, Ohio, Kimberly Mackay 216.444.4650 or MACKAYK@ccf.org
University of Virginia, Charlottesville, Va., Lisa Johnson, BA, CCRC 434.982.3198 or SFJ8N@hscmail.mcc.virginia.edu
Medical College of Wisconsin, Milwaukee, Wis., Sonia Maldonado-Schmidt, RN, 414.805.0752 or smaldonado@mcw.edu

Website:

NIH Study Details

 

Sirolimus for Massive Polycystic Liver (SILVER)
 

Intervention:

Drug: Sirolimus

Sponsor:

Seoul National University Hospital
Study Phase: II & III

Status:

Recruiting

Age Group:

18 Years to 65 Years

Enrollment goal:

44

Description:

This is a open-label, prospective study to evaluate the effectiveness and safety of Sirolimus to reduce cyst growth in ADPKD patients with massive polycystic liver.

Contact:

Curie Ahn, MD, PhD 82-2-2072-2222 or curie@snu.ac.kr

Website:

NIH Study Details

 

Somatostatin in Patients with ADPKD and Moderate to Severe Renal Insufficiency (ALADIN 2)

 

Intervention:

Octreotide-LAR

Sponsor:

Mario Negri Institute for Pharmacological Research
Study Phase: III
Status: Recruiting
Age Group: 18-75

Enrollment goal:

80

Description:

To assess the efficacy of one year treatment with long-acting somatostatin analogue (Octreotide LAR)
compared to placebo in slowing kidney and liver growth rate in patients with ADPKD and moderate/severe
renal insufficiency.
Contact: Norberto Perico, Mario Negri Institute for Pharmacological Research
Website: NIH Study Details

 

Study of Lanreotide to Treat Polycystic Kidney Disease (DIPAK1) 

 

Intervention:

Drug: Lanreotide

Sponsor:

University Medical Centre Groningen

Collaborators

Leiden University Medical Center, Erasmus Medical Center, Radboud University

Study Phase: III

Status:

Recruiting

Age Group:

18 Years to 60 Years

Enrollment goal:

300

Description:

The purpose of this study is to investigate whether the somatostatin analogue Lanreotide slows progression of polycystic and liver disease in ADPKD patients.

Contact:

Esther Meijer, MD, PhD esther.meijer@umcg.nl
Ron Gansevoort, MD, PhD r.t.gansevoort@umcg.nl

Website:

NIH Study Details

 

Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

 

Intervention:

Drugs: Triptolide-containing formulation; placebo

Sponsor:

Shanghai Changzheng Hospital

Study Phase:

III

Status:

Recruiting

Age Group:

40 - 75 years

Enrollment goal:

100

Description:

Randomized controlled trial

Contacts:


Changlin Mei, MD  chlmei1954@126.com

Website:

NIH Study Details

 

Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide (Vitamin B3) in Polycystic Kidney Disease (NIAC-PKD1)

 

Interventional

Dietary supplement: Niacinamide

Sponsor:

Alan Yu, MB, BChir (principal investigator) - University of Kansas Medical Center Research Institute

Study Phase:

II

Status:

Recruiting

Age Group:

18 - 50 years

Enrollment goal:

15

Description:

Niacinamide is a form of vitamin B3. Vitamin B3 is found in many foods including yeast, meat, fish, milk, eggs, green vegetables, beans, and cereal grains. Recent studies in mice have shown that niacinamide, at high doses, may slow kidney cyst growth from polycystic kidney disease (PKD).  By doing this study, the researchers will determine if a larger, long-term study to test whether niacinamide slows progression of PKD is justified.

Contact:

Cathy Creed, RN, BSN (913) 588-0053 CCREED@kumc.edu

Website:

NIH Study Details 

 

Ursodeoxycholic Acid as Treatment for Polycystic Liver Disease (CURSOR)

 

Interventional

Ursodeoxycholic Acid

Sponsor:

Radboud University

Collaborators:

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Donostia University Hospital Spain

Study Phase:

II

Status:

Recruiting

Age Group:

18 - 80 years

Enrollment goal:

34

Description:

Polycystic liver disease (PLD) is a rare disorder characterized by >20 fluid-filled hepatic cysts. Polycystic livers are present in the combination with renal cysts as a manifestation of autosomal dominant polycystic kidney disease (ADPKD), or isolated in the absence of renal cysts as autosomal dominant polycystic liver disease (ADPLD or PCLD). PLD patients are confronted with symptoms caused by the mass effect of their polycystic liver every day for the rest of their life. There is no standard therapeutic option for symptomatic PLD patients. Current options are fairly invasive or their efficacy is only moderate.

The investigators hypothesize that UDCA is an effective therapeutic tool in reducing liver volume in PLD.

To demonstrate whether UDCA-therapy is effective in reducing total liver volume in PLD patients. Also, the investigators want to assess whether UDCA modifies quality of life. Finally, the investigators want to assess safety and tolerability.

Contact:

Hedwig MA D'Agnolo, drs.hedwig.dagnolo@radboudumc.nl

Website:

NIH Study Details

 

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©2014, PKD Foundation ·The PKD Foundation is a 501 (c)(3), 509 (a)(1) public charity.

©2014, PKD Foundation ·The PKD Foundation is a 501 (c)(3), 509 (a)(1) public charity.