Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00537979

Purpose

Prospective, non-randomized, multi-center study to assess the efficacy and safety of paricalcitol injection or oral administered over 6 months to patients with secondary hyperparathyroidism on dialysis

Condition	Intervention	Phase
Secondary Hyperparathyroidism Dialysis	Drug: Paricalcitol injection Drug: Paricalcitol capsules	Phase IV

Drug Information available for: 19-Nor-1alpha,25-dihydroxyvitamin D2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis

Further study details as provided by Abbott:

Primary Outcome Measures:

Proportion of subjects who achieve at least a 50% reduction in iPTH compared to baseline level [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Analysis of episodes of hypercalcemia (> 11.5 mg/dL), hyperphosphatemia (> 7.0 mg/dL) and elevations of calcium x phosphorus product (> 75) [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Proportion of subjects who achieve an iPTH <300 pg/mL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Time required to achieve: (1) a reduction in iPTH less than <300 pg/mL;(2) a 50% reduction in iPTH compared to the baseline level; and (3) either a reduction in iPTH less than <300 pg/mL or a 50% reduction in iPTH compared to the baseline level [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Duration of response to treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Health-related quality of life with paricalcitol injection or oral treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	September 2007
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Paricalcitol injection: Active Comparator ABT-358 Zemplar	Drug: Paricalcitol injection Most recent iPTH level in pg/mL divided by 100 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly
Paricalcitol capsules: Active Comparator ABT-358 Zemplar	Drug: Paricalcitol capsules Most recent iPTH level in pg/mL divided by 80 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients >=18 years with secondary hyperparathyroidism (iPTH >= 300 pg/mL)
Patients in a chronic hemodialysis or peritoneal dialysis program previously treated with vitamin D metabolites or without previous treatment
Patients in which treatment with paricalcitol injection or oral is clinically indicated according to the criteria of the participating investigator
Patients providing their signed informed consent to participate in the trial

Exclusion Criteria:

Patients with severe hyperparathyroidism (iPTH > 3,000 pg/ml)
Patients with hypercalcaemia (calcium >=11.0 mg/dl, adjusted according to Albumin level), hyperphosphataemia (phosphorus >= 6.5 mg/dl) or patients with calcium x phosphorus >= 70
Known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients
Patients who have participated in clinical studies within the last month or who are currently enrolled in clinical studies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537979

Contacts

Contact: Claudia Rodriguez, BSc	52 55 58 09 75 14	claudia.rodriguez@abbott.com
Contact: Shanti Moreno, MD	52 55 57 26 47 41	shanti.moreno@abbott.com

Locations

Mexico
	Recruiting
Puebla, Mexico, 72400
Mexico, Distrito Federal
	Active, not recruiting
Col. Insurgentes, Mexico, Distrito Federal, Mexico, 03900
	Recruiting
Col. Tlalpan, Mexico, Distrito Federal, Mexico, 14000
	Active, not recruiting
Col Pedregal Del Tlalpan, Mexico, Distrito Federal, Mexico, 14140
	Active, not recruiting
Col. Tlalpan, Mexico, Distrito Federal, Mexico, 14080
	Recruiting
Col. Florida, Mexico, Distrito Federal, Mexico, 10300
	Recruiting
Xochimilco, Distrito Federal, Mexico, 16070
	Recruiting
Col. Letran Valle, Distrito Federal, Mexico, 03650
	Not yet recruiting
Azcapotzalco, Distrito Federal, Mexico, 02080
Mexico, JALISCO
	Withdrawn
Guadalajara, JALISCO, Mexico, 45150
Mexico, Jalisco
	Recruiting
Zapopan, Jalisco, Mexico, 45150
	Not yet recruiting
Zapopan, Jalisco, Mexico, 45116
Mexico, Morelia
	Recruiting
Col. Zapata, Jojutla, Morelia, Mexico, 62900

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Max Sarachaga, MD

Abbott

More Information

No publications provided

Responsible Party:	Abbott Laboratories ( Max Sarachaga, MD )
Study ID Numbers:	W10-129
Study First Received:	September 28, 2007
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00537979 History of Changes
Health Authority:	Mexico: Ministry of Health

Keywords provided by Abbott:

Dialysis
Hyperparathyroidism
Zemplar

Study placed in the following topic categories:

Parathyroid Diseases
Hyperparathyroidism, Secondary
Hyperparathyroidism
Vitamins
Ergocalciferols
Neoplasm Metastasis

Endocrine System Diseases
Trace Elements
Bone Density Conservation Agents
Micronutrients
Endocrinopathy

Additional relevant MeSH terms:

Parathyroid Diseases
Growth Substances
Physiological Effects of Drugs
Ergocalciferols
Endocrine System Diseases
Bone Density Conservation Agents
Pharmacologic Actions
Hyperparathyroidism, Secondary

Neoplastic Processes
Neoplasms
Pathologic Processes
Hyperparathyroidism
Vitamins
Neoplasm Metastasis
Micronutrients

ClinicalTrials.gov processed this record on May 06, 2009