Clareo Health | Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
OPKO IP Holdings II, Inc.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Body mass index between 18 and 40
On maintenance hemodialysis three times per week
Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL
Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
Visit 1: Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
Serum 25-hydroxyvitamin D level greater than or equal to 15 ng/mL
Visit 2: Serum iPTH value greater than 300 pg/mL
Visit 2: Serum Ca x P product less than 56 \[mg/dl\]2
Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and length of study
