Chronic Kidney Disease Clinical Trial
Official title:
Single-Dose, Two-Period, Open Label, Dose Determination, Randomized, Cross-Over Study of CTAP201 Injection and Doxercalciferol (Hectorol) Injection in Subjects With Stage 5 CKD and SHPT on Hemodialysis
Verified date | November 2009 |
Source | OPKO Health, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201.
Status | Completed |
Enrollment | 24 |
Est. completion date | October 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Northeast Clinical Research | Allentown | Pennsylvania |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Southwest Houston Research Ltd. | Houston | Texas |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Pivotal Reseach Centers | Peoria | Arizona |
United States | Western New England Renal and Transplant Associates | Springfield | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
OPKO IP Holdings II, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood levels of CTAP201 and doxercalciferol | Day 1 and Day 15 of each dose level | No | |
Primary | Safety of a single dose of CTAP201 Injection | Throughout the study | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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