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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00792857
First Posted: November 18, 2008
Last Update Posted: September 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
OPKO Health, Inc. ( OPKO IP Holdings II, Inc. )
  Purpose
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.

Condition Intervention Phase
Chronic Kidney Disease Secondary Hyperparathyroidism Chronic Renal Insufficiency Chronic Renal Failure Drug: CTAP201 Injection Drug: Doxercalciferol Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by OPKO Health, Inc. ( OPKO IP Holdings II, Inc. ):

Primary Outcome Measures:
  • Blood levels of CTAP201 and doxercalciferol [ Time Frame: Day 1 and Day 15 of each dose level ]
  • Safety of a single dose of CTAP201 Injection [ Time Frame: Throughout the study ]

Enrollment: 24
Study Start Date: November 2008
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Hectorol
Active Comparator: Doxercalciferol
Active at dose b or dose c
Drug: Doxercalciferol
Comparison of different dose strengths of doxercalciferol after single dose.
Other Name: Hectorol

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00792857


Locations
United States, Arizona
Pivotal Reseach Centers
Peoria, Arizona, United States, 85381
United States, Massachusetts
Western New England Renal and Transplant Associates
Springfield, Massachusetts, United States, 01107
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45206
United States, Pennsylvania
Northeast Clinical Research
Allentown, Pennsylvania, United States, 18103-6379
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Southwest Houston Research Ltd.
Houston, Texas, United States, 77099
Sponsors and Collaborators
OPKO IP Holdings II, Inc.
Investigators
Study Director: Joel Melnick, MD OPKO Renal
  More Information

Responsible Party: OPKO IP Holdings II, Inc.
ClinicalTrials.gov Identifier: NCT00792857     History of Changes
Other Study ID Numbers: CTAP201-CL-1007
First Submitted: November 14, 2008
First Posted: November 18, 2008
Last Update Posted: September 29, 2014
Last Verified: November 2009

Keywords provided by OPKO Health, Inc. ( OPKO IP Holdings II, Inc. ):
Parathyroid Diseases
Renal Insufficiency
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Vitamin D
Hyperparathyroidism
Renal Insufficiency, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:
Kidney Diseases
Neoplasm Metastasis
Renal Insufficiency, Chronic
Renal Insufficiency
Hyperparathyroidism
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Urologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases
1 alpha-hydroxyergocalciferol
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents