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

Phase 1

Completed

• Conditions: Chronic Kidney Disease; Secondary Hyperparathyroidism; Chronic Renal Failure; Chronic Renal Insufficiency
• Interventions: Drug: CTAP201 Injection; Drug: Doxercalciferol

• Registration Number: NCT00792857
• Lead Sponsor: OPKO IP Holdings II, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-14
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-18
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Status Verified: 2009-11
• Last Update Submitted: 2014-09-26
• Last Update Posted: 2014-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CTAP201 Injection at dose a	CTAP201 Injection	CTAP201 at dose a
Doxercalciferol at dose a	Doxercalciferol	Active at dose a
CTAP201 Injection	CTAP201 Injection	CTAP201 at dose b or dose c
Doxercalciferol	Doxercalciferol	Active at dose b or dose c

Primary Outcome Measures

Name	Time	Method
Safety of a single dose of CTAP201 Injection	Throughout the study
Blood levels of CTAP201 and doxercalciferol	Day 1 and Day 15 of each dose level

Trial Locations

Locations (6)

Pivotal Reseach Centers; 🇺🇸 Peoria, Arizona, United States

Western New England Renal and Transplant Associates; 🇺🇸 Springfield, Massachusetts, United States

Northeast Clinical Research; 🇺🇸 Allentown, Pennsylvania, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Southwest Houston Research Ltd.; 🇺🇸 Houston, Texas, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States