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 |
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.
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
3545 Cray Court
San Diego, California 92103
San Diego, California 92103
Phone: 619-471-9585
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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
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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700 Childrens Drive
Columbus, Ohio 43205
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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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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807 Childrens Way
Jacksonville, Florida 32207
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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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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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
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
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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South 34th Street
Philadelphia, Pennsylvania 19104
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
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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601 Elmwood Avenue
Rochester, New York 14642
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
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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4202 E Fowler Ave
Tampa, Florida 33620
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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Aurora, Colorado 80045
Phone: 303-724-2353
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733 North Broadway
Baltimore, Maryland 21205
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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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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225 E Chicago Ave
Chicago, Illinois 60611
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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500 University Dr
Hershey, Pennsylvania 17033
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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340 W 10th St #6200
Indianapolis, Indiana 46202
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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University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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University of Louisville The University of Louisville is a state supported research university located in...
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Miami, Florida 33136
Phone: 305-243-7985
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
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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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
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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660 S Euclid Ave
Saint Louis, Missouri 63110
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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Tampa, Florida 33607
Phone: 813-870-4432
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111 Michigan Ave NW
Washington, District of Columbia
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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