Dose-Response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis (HD) - Full Text View

Sponsors and Collaborators:	Abbott Abbott Japan Co.,Ltd
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00667576

Purpose

To examine the dose response of paricalcitol injection, subjects will administer clinical supplies 3 times a week, 12 weeks at dialysis session in dose-titration manner.

Condition	Intervention	Phase
Secondary Hyperparathyroidism Hemodialysis	Drug: paricalcitol Drug: maxacalcitol	Phase II

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: 19-Nor-1alpha,25-dihydroxyvitamin D2 1,25-Dihydroxy-22-oxavitamin D3

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Dose-Response Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism (Examination of Initial Dose and Incremental Dose)

Further study details as provided by Abbott:

Primary Outcome Measures:

The proportion of subjects with >=50% decrease from baseline in iPTH [ Time Frame: Final visit ] [ Designated as safety issue: No ]
The incident rate of hypercalcemia [ Time Frame: During the study ] [ Designated as safety issue: Yes ]
The incident rate of hyperphosphatemia [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The mean change of iPTH [ Time Frame: Final visit ] [ Designated as safety issue: No ]
The proportion of subjects with iPTH <=180 pg/mL [ Time Frame: Final visit ] [ Designated as safety issue: No ]
The proportion of subjects with two or more >=50% decrease from baseline in iPTH. The time course change of iPTH. [ Time Frame: During the study ] [ Designated as safety issue: No ]
The duration of two consecutive iPTH >=50% or < 180 pg/mL [ Time Frame: During the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	April 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
paricalcitol A group: Experimental 2 mcg with incremental of 1 mcg	Drug: paricalcitol IV, See Arm Description for dosage information
paricalcitol B group: Experimental 2 mcg with incremental of 2 mcg	Drug: paricalcitol IV, See Arm Description for dosage information
paricalcitol C group: Experimental 4 mcg with incremental of 1 mcg	Drug: paricalcitol IV, See Arm Description for dosage information
paricalcitol D group: Experimental 4 mcg with incremental of 2 mcg	Drug: paricalcitol IV, See Arm Description for dosage information
maxacalcitol E group: Active Comparator 5 or 10 mcg with incremental of 2.5 mcg	Drug: maxacalcitol IV, 5 mcg or 10 mcg with incremental dose of 2.5 mcg

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients diagnosed with Chronic Kidney Disease.
iPTH >=300 pg/mL, Ca:8.4-10.2 mg/dL, P <=6.5 mg/dL

Exclusion Criteria:

Patients taking drugs that affect iPTH, calcium or bone metabolism

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667576

Locations

Japan

Hokkaido, Japan

Ibaragi, Japan

Saitama, Japan

Chiba, Japan

Tokyo, Japan

Kanagawa, Japan

Kumamoto, Japan

Aichi, Japan

Osaka, Japan

Fukuoka, Japan

Nagasaki, Japan

Nagano, Japan

Sponsors and Collaborators

Abbott

Abbott Japan Co.,Ltd

Investigators

Study Director:

Ryotaro Matsuzawa

Abbott

More Information

Responsible Party:	Abbott ( Yoshihiko Ueki )
Study ID Numbers:	M10-309
Study First Received:	April 24, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00667576
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:

secondary hyperparathyroidism
hemodialysis
paricalcitol
maxacalcitol

Study placed in the following topic categories:

Parathyroid Diseases
Renal Insufficiency
Ergocalciferols
Kidney Failure, Chronic
Endocrine System Diseases
Hyperparathyroidism, Secondary
Maxacalcitol
Vitamin D

Hyperparathyroidism
Urologic Diseases
Renal Insufficiency, Chronic
Neoplasm Metastasis
Kidney Diseases
Endocrinopathy
Kidney Failure

Additional relevant MeSH terms:

Anticarcinogenic Agents
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Protective Agents
Pharmacologic Actions

Neoplastic Processes
Neoplasms
Pathologic Processes
Therapeutic Uses
Vitamins
Micronutrients
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009