Phase
Condition
Hyperparathyroidism
Renal Failure
Kidney Disease
Treatment
N/AClinical Study ID
Ages 10-16 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 monthsprior to Screening
Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism
For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor [VDR] Activators or those who have completed a 2 to 12 week washout), the subject mustmeet the following laboratory criteria prior to enrollment:
A corrected calcium value ≥ 8.2 and ≤ 10.4 mg/dL
A phosphorus value ≤ 6.5 mg/dL
An intact parathyroid hormone (iPTH) value > 300 pg/mL and less ≤ 2000 pg/mL
Exclusion
Exclusion Criteria:
Subject is expected or scheduled to receive a living donor kidney transplant within 3months of Screening or is a kidney transplant patient requiring full immunosuppressanttherapy
Subject is expected to stop peritoneal dialysis or hemodialysis within 4 months ofScreening (per investigator discretion)
Subject has had a parathyroidectomy within 12 weeks prior to Screening
Subject has had symptomatic or significant hypocalcemia requiring VDR Activatortherapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior toScreening
Subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in anequivalent dose of greater than 5 mg prednisone daily, or other drugs known to affectcalcium or bone metabolism within 4 to 8 weeks prior to Dosing
Subject is receiving cinacalcet at the time of Screening
Study Design
Connect with a study center
Site Reference ID/Investigator# 114135
Essen, 45147
GermanySite Not Available
Site Reference ID/Investigator# 112995
Lisbon, 1169-045
PortugalSite Not Available
Site Reference ID/Investigator# 117995
Manchester, M13 9WL
United KingdomSite Not Available
Site Reference ID/Investigator# 79955
Birmingham, Alabama 35255
United StatesSite Not Available
Site Reference ID/Investigator# 48565
Los Angeles, California 90095-1752
United StatesSite Not Available
Site Reference ID/Investigator# 48560
Miami, Florida 33155-4078
United StatesSite Not Available
Site Reference ID/Investigator# 53324
Atlanta, Georgia 30322
United StatesSite Not Available
Site Reference ID/Investigator# 48552
Chicago, Illinois 60611
United StatesSite Not Available
Site Reference ID/Investigator# 102275
Louisville, Kentucky 40202
United StatesSite Not Available
Site Reference ID/Investigator# 48570
Kansas City, Missouri 64108
United StatesSite Not Available
Site Reference ID/Investigator# 48555
St. Louis, Missouri 63110
United StatesSite Not Available
Site Reference ID/Investigator# 48564
Livingston, New Jersey 07039
United StatesSite Not Available
Site Reference ID/Investigator# 95275
Greenville, North Carolina 27834
United StatesSite Not Available
Site Reference ID/Investigator# 77456
Cincinnati, Ohio 45229
United StatesSite Not Available
Site Reference ID/Investigator# 102115
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Site Reference ID/Investigator# 53326
Dallas, Texas 75390
United StatesSite Not Available
Site Reference ID/Investigator# 85893
San Antonio, Texas 78229
United StatesSite Not Available
Site Reference ID/Investigator# 48566
Salt Lake City, Utah 84113
United StatesSite Not Available
Site Reference ID/Investigator# 116555
Milwaukee, Wisconsin 53226
United StatesSite Not Available

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