PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry



Status:Recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:1/26/2019
Start Date:September 2008
End Date:September 2023
Contact:Caroline Moore
Email:MEDINFO@bmrn.com
Phone:(651) 523-0310

Use our guide to learn which trials are right for you!

The objective of this study is to evaluate the safety of long-term treatment with Kuvan.

The PKUDOS program is a voluntary, multicenter, strictly observational program for patients
with PKU who have either received Kuvan therapy, or currently receive Kuvan, or intends to
begin receiving Kuvan therapy within 90 days of entering the registry.

PKUDOS Registry

Inclusion Criteria:

- Patient has confirmed diagnosis of PKU with hyperphenylalaninemia documented by a
Phenylalanine level of greater than or equal to 360 umol/L (6 mg/dL)

- Patient has previously received Kuvan

- Patient is currently receiving Kuvan

- Patient intends to receive Kuvan therapy within 90 days of enrollment into the
registry

- The Patient is being followed at a PKUDOS participating center

- Willing and able to provide written authorization or, if under the age of 18 years,
provide written assent (if required) and written patient authorization by a parent or
legal guardian

- Willing to provide personal health information

Exclusion Criteria:

- Patients are not eligible to participate in PKUDOS if they are participating in a
BioMarin-sponsored clinical study of Kuvan

- Patients not previously treated with Kuvan and patients that are unwilling to begin
Kuvan therapy within 90 days of entry into the registry

PKU MOMS Subregistry

Inclusion Criteria:

- Willing to enroll in (or are already enrolled in) PKUDOS

- Agree to follow the standard of care for pregnant women with PKU in the United States
(NIH, 200, NIH Consensus Statement)

- Agree to be followed by a hospital or PKU clinic offering the standard of care for
maternal PKU

- Are within 10 weeks of their last menstrual period

Exclusion Criteria:

- Patients who have not adhered to the standard of care for pregnant women with PKU in
the United States are not eligible to participate in PKU MOMS
We found this trial at
58
sites
West Hartford, Connecticut 06119
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1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Phone: 330-543-8792
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Phone: 614-722-2661
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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Gainesville, Florida 32610
(352) 392-3261
Phone: 352-273-7763
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Phone: 319-356-2674
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Phone: 407-650-7156
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Jacksonville, FL
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Manhasset, NY
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Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-301-1371
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Phone: 757-668-9723
Children's Hospital of The King's Daughters Children
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1717 South Orange Avenue # 100
Orlando, Florida 32806
(407) 650-7000
Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
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Philadelphia, Pennsylvania 19134
Phone: 215-427-5081
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Philadelphia, PA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 215-590-3219
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-418-1061
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Phone: 585-275-5857
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-587-3605
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Phone: 813-259-8842
University of South Florida The University of South Florida is a high-impact, global research university...
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Tampa, FL
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Albany, New York 12208
Phone: 518-262-5027
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Albany, NY
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Aurora, Colorado 80045
Phone: 303-724-2353
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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Boston, Massachusetts 02115
Phone: 617-355-6515
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Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-843-9946
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Charlottesville, Virginia 22908
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Phone: 312-227-6777
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Columbia, Missouri 65203
Phone: 573-882-5891
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Decatur, Georgia 30033
Phone: 404-778-8575
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Decatur, GA
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Greenwood, South Carolina 29646
Phone: 864-941-8100
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Helena, Montana 59601
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Phone: 717-531-1278
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Houston, Texas 77030
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Phone: 317-278-6650
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Kansas City, Missouri 64123
Phone: 816-701-1395
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Knoxville, Tennessee 37920
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Los Angeles, California 90033
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Los Angeles, California 90095
(310) 825-4321
Phone: 301-825-8084
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Phone: 502-852-5681
University of Louisville The University of Louisville is a state supported research university located in...
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Phone: 414-266-8674
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Morgantown, WV
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Morristown, New Jersey 07960
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New Orleans, Louisiana 70112
Phone: 504-988-2989
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New York, New York 10029
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Phone: 402-559-5698
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Phone: 412-692-3150
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Providence, Rhode Island 02903
Phone: 401-444-5794
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Sacramento, California 95816
Phone: 916-733-4482
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Saint George, Utah 84770
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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3545 Cray Court
San Diego, California 92103
Phone: 619-471-9585
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Sioux Falls, South Dakota 57117
Phone: 605-328-1389
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Stanford, California 94305
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Tulsa, Oklahoma 74136
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Valhalla, New York 10595
Phone: 914-304-5316
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Phone: 202-476-6216
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Wichita, Kansas 67208
Phone: 316-962-7386
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