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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00792857
Other study ID # CTAP201-CL-1007
Secondary ID
Status Completed
Phase Phase 1
First received November 14, 2008
Last updated September 26, 2014
Start date November 2008
Est. completion date October 2009

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
CTAP201 Injection
Comparison of different dose strengths of CTAP201 after single dose.
Doxercalciferol
Comparison of different dose strengths of doxercalciferol after single dose.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
OPKO IP Holdings II, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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
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