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 RicoActive - Recruiting
Arkansas Children's Hospital /ID# 225417
Little Rock, Arkansas 72202
United StatesCompleted
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 /ID# 252150
Stanford, California 94305
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
Holtz Childrens Hospital, University of Miami /ID# 225636
Miami, Florida 33136-1005
United StatesActive - Recruiting
Nicklaus Children's Hospital /ID# 210517
Miami, Florida 33155-3009
United StatesCompleted
Emory University /ID# 140665
Atlanta, Georgia 30322-1014
United StatesCompleted
Augusta University Medical Center /ID# 252149
Augusta, Georgia 30912-0004
United StatesActive - Recruiting
Boston Children's Hospital /ID# 162863
Boston, Massachusetts 02115
United StatesActive - Recruiting
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 StatesCompleted
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 StatesActive - Recruiting
Children's Hospital of Philadelphia - Main /ID# 213802
Philadelphia, Pennsylvania 19104-4319
United StatesActive - Recruiting
University of Texas Southwestern Medical Center /ID# 210495
Dallas, Texas 75390-7208
United StatesActive - Recruiting
University of Utah /ID# 140669
Salt Lake City, Utah 84112-5500
United StatesActive - Recruiting
Seattle Children's Hospital /ID# 162861
Seattle, Washington 98105
United StatesCompleted
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