Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
Launched by OPKO IP HOLDINGS II, INC. · Nov 17, 2008
Trial Information
Current as of May 27, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • Taking cytochrome P450 3A inhibitors and/or inducers
- • Abnormal liver functions
About Opko Ip Holdings Ii, Inc.
OPKO IP Holdings II, Inc. is a biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapeutics and diagnostic solutions. As a subsidiary of OPKO Health, Inc., the company leverages cutting-edge research and advanced technologies to address unmet medical needs across various therapeutic areas. With a commitment to enhancing patient care, OPKO IP Holdings II, Inc. actively engages in clinical trials to evaluate the safety and efficacy of its product candidates, aiming to bring novel treatments to market that improve health outcomes and quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nashville, Tennessee, United States
Cincinnati, Ohio, United States
Springfield, Massachusetts, United States
Peoria, Arizona, United States
Allentown, Pennsylvania, United States
Houston, Texas, United States
Patients applied
Trial Officials
Joel Melnick, MD
Study Director
OPKO Renal
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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