Phase
Condition
Kidney Failure (Pediatric)
Neoplasm Metastasis
Hyperparathyroidism
Treatment
Paricalcitol
Clinical Study ID
Ages < 9 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant is currently diagnosed with and/or being treated for secondaryhyperparathyroidism (SHPT).
Participant must be diagnosed with chronic kidney disease (CKD) stage 5 receivingperitoneal dialysis (PD) or hemodialysis (HD) for at least 30 days prior to initialScreening.
For entry into the Washout Period (for vitamin D receptor activator [VDRA] non-naiveparticipants), the participant must meet the appropriate laboratory criteria basedupon the participant's age as described in the protocol.
For entry into the Dosing Period (for VDRA-naive participants or VDRA non-naiveparticipants who have completed the Washout Period), the participant must meet theappropriate laboratory criteria based upon the participant's age as described in theprotocol.
Exclusion
Exclusion Criteria:
Participant is scheduled to receive a living donor kidney transplant within 3 monthsof Screening or is a kidney transplant recipient.
Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD)within 3 months of the initial Screening visit.
Participant has had a parathyroidectomy within 12 weeks prior to Screening.
Participant is taking maintenance calcitonin, bisphosphonates, glucocorticoids (in adose equivalent to more than > 0.16 mg/kg/day or 5 mg prednisone/day, whichever islower), 4 weeks prior to Dosing.
Participant is receiving calcimimetics at the time of Screening or is expected toinitiate calcimimetics at any time throughout the study.
Participant is unable to take oral medications.
Study Design
Connect with a study center
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663
San Juan, 00935
Puerto RicoSite Not Available
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663
San Juan 4568127, 00935
Puerto RicoSite Not Available
Arkansas Children's Hospital /ID# 225417
Little Rock, Arkansas 72202
United StatesSite Not Available
Arkansas Children's Hospital /ID# 225417
Little Rock 4119403, Arkansas 4099753 72202
United StatesSite Not Available
University of California, Los Angeles /ID# 140668
Los Angeles, California 90095
United StatesSite Not Available
Stanford University /ID# 252150
Redwood City, California 94063
United StatesActive - Recruiting
Stanford University School of Medicine - Redwood City /ID# 252150
Redwood City, California 94063
United StatesSite Not Available
Stanford University /ID# 252150
Stanford, California 94305
United StatesSite Not Available
Stanford University School of Medicine - Redwood City /ID# 252150
Redwood City 5386834, California 5332921 94063
United StatesSite Not Available
Colorado Children's Hospital /ID# 162862
Aurora, Colorado 80045
United StatesSite Not Available
Children's National Medical Center /ID# 225991
Washington, District of Columbia 20010-2916
United StatesActive - Recruiting
Childrens National Medical Center /ID# 225991
Washington, District of Columbia 20010-2916
United StatesSite Not Available
Childrens National Medical Center /ID# 225991
Washington D.C. 4140963, District of Columbia 4138106 20010-2916
United StatesSite Not Available
Holtz Childrens Hospital, University of Miami /ID# 225636
Miami, Florida 33136-1005
United StatesSite Not Available
Nicklaus Children's Hospital /ID# 210517
Miami, Florida 33155-3009
United StatesCompleted
Holtz Childrens Hospital, University of Miami /ID# 225636
Miami 4164138, Florida 4155751 33136-1005
United StatesSite Not Available
Nicklaus Children's Hospital /ID# 210517
Miami 4164138, Florida 4155751 33155-3009
United StatesSite Not Available
Emory University /ID# 140665
Atlanta, Georgia 30322-1014
United StatesSite Not Available
Augusta University Medical Center /ID# 252149
Augusta, Georgia 30912-0004
United StatesSite Not Available
Emory University /ID# 140665
Atlanta 4180439, Georgia 4197000 30322-1014
United StatesSite Not Available
Augusta University Medical Center /ID# 252149
Augusta 4180531, Georgia 4197000 30912-0004
United StatesSite Not Available
Boston Children's Hospital /ID# 162863
Boston, Massachusetts 02115
United StatesSite Not Available
Boston Children's Hospital /ID# 162863
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
Childrens Mercy Hosp and Clin /ID# 140672
Kansas City, Missouri 64108
United StatesSite Not Available
Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057
Charlotte, North Carolina 28203-5866
United StatesSite Not Available
Levine Children's Specialty Center- Charlotte /ID# 216057
Charlotte, North Carolina 28203-5866
United StatesCompleted
Wake Forest University Health Services /ID# 266045
Winston Salem, North Carolina 27157-0001
United StatesSite Not Available
Atrium Health Wake Forest Baptist Medical Center /ID# 266045
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Wake Forest University Health Services /ID# 266045
Winston-Salem, North Carolina 27157-0001
United StatesSite Not Available
Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057
Charlotte 4460243, North Carolina 4482348 28203-5866
United StatesSite Not Available
Atrium Health Wake Forest Baptist Medical Center /ID# 266045
Winston-Salem 4499612, North Carolina 4482348 27157
United StatesSite Not Available
Children's Hospital of Philadelphia - Main /ID# 213802
Philadelphia, Pennsylvania 19104-4319
United StatesSite Not Available
Children's Hospital of Philadelphia - Main /ID# 213802
Philadelphia 4560349, Pennsylvania 6254927 19104-4319
United StatesSite Not Available
University of Texas Southwestern Medical Center /ID# 210495
Dallas, Texas 75390-7208
United StatesSite Not Available
University of Texas Southwestern Medical Center /ID# 210495
Dallas 4684888, Texas 4736286 75390-7208
United StatesSite Not Available
University of Utah /ID# 140669
Salt Lake City, Utah 84112-5500
United StatesSite Not Available
University of Utah /ID# 140669
Salt Lake City 5780993, Utah 5549030 84112-5500
United StatesSite Not Available
Seattle Children's Hospital /ID# 162861
Seattle, Washington 98105
United StatesSite Not Available
Seattle Children's Hospital /ID# 162861
Seattle 5809844, Washington 5815135 98105
United StatesSite Not Available

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