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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:
Information provided by (Responsible Party):
OPKO Health, Inc. ( OPKO IP Holdings II, Inc. )
ClinicalTrials.gov Identifier:
NCT00792857
First received: November 14, 2008
Last updated: September 26, 2014
Last verified: November 2009
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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.:

Primary Outcome Measures:
  • Blood levels of CTAP201 and doxercalciferol [ Time Frame: Day 1 and Day 15 of each dose level ] [ Designated as safety issue: No ]
  • Safety of a single dose of CTAP201 Injection [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: OPKO Health, Inc. ( OPKO IP Holdings II, Inc. )
ClinicalTrials.gov Identifier: NCT00792857     History of Changes
Other Study ID Numbers: CTAP201-CL-1007
Study First Received: November 14, 2008
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014