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

September 26, 2014 updated by: OPKO IP Holdings II, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Pivotal Reseach Centers
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Western New England Renal and Transplant Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • University of Cincinnati
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103-6379
        • Northeast Clinical Research
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Texas
      • Houston, Texas, United States, 77099
        • SouthWest Houston Research LTD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CTAP201 Injection at dose a
CTAP201 at dose a
Drug: CTAP201 Injection
Comparison of different dose strengths of CTAP201 after single dose.
Experimental: CTAP201 Injection
CTAP201 at dose b or dose c
Drug: CTAP201 Injection
Comparison of different dose strengths of CTAP201 after single dose.
Active Comparator: Doxercalciferol at dose a
Active at dose a
Drug: Doxercalciferol
Comparison of different dose strengths of doxercalciferol after single dose.
Other Names:
  • Hectorol
Active Comparator: Doxercalciferol
Active at dose b or dose c
Drug: Doxercalciferol
Comparison of different dose strengths of doxercalciferol after single dose.
Other Names:
  • Hectorol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood levels of CTAP201 and doxercalciferol
Time Frame: Day 1 and Day 15 of each dose level
Day 1 and Day 15 of each dose level
Safety of a single dose of CTAP201 Injection
Time Frame: Throughout the study
Throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OPKO IP Holdings II, Inc.

Investigators

  • Study Director: Joel Melnick, MD, OPKO Renal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

November 14, 2008

First Submitted That Met QC Criteria

November 17, 2008

First Posted (Estimate)

November 18, 2008

Study Record Updates

Last Update Posted (Estimate)

September 29, 2014

Last Update Submitted That Met QC Criteria

September 26, 2014

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTAP201-CL-1007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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