Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792857
• Other study ID #: CTAP201-CL-1007
• 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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Chronic Renal Failure
• Chronic Renal Insufficiency
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Kidney Failure, Chronic
• Neoplasm Metastasis
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

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