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

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:	April 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, Distrito Federal
		Recruiting
	Col. Insurgentes, Mexico, Distrito Federal, Mexico, 03900
		Recruiting
	Col. Tlalpan, Mexico, Distrito Federal, Mexico, 14000
		Recruiting
	Col. Florida, Mexico, Distrito Federal, Mexico, 10300
		Recruiting
	Col. Tlalpan, Mexico, Distrito Federal, Mexico, 14080
		Recruiting
	Col Pedregal Del Tlalpan, Mexico, Distrito Federal, Mexico, 14140
		Recruiting
	Xochimilco, Distrito Federal, Mexico, 16070

Mexico, JALISCO
		Recruiting
	Guadalajara, JALISCO, Mexico, 45150

Mexico, Jalisco
		Recruiting
	Zapopan, Jalisco, Mexico, 45150

Mexico, Morelia
		Recruiting
	Col. Zapata, Jojutla, Morelia, Mexico, 62900

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Max Sarachaga, MD	Abbott

More Information

Responsible Party:	Abbott Laboratories ( Max Sarachaga, MD )
Study ID Numbers:	W10-129
First Received:	September 28, 2007
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00537979
Health Authority:	Mexico: Ministry of Health

Keywords provided by Abbott:

Dialysis

Hyperparathyroidism

Zemplar

Study placed in the following topic categories:

Parathyroid Diseases

Hyperparathyroidism, Secondary

Vitamin D

Hyperparathyroidism

Ergocalciferols

Neoplasm Metastasis

Endocrine System Diseases

Endocrinopathy

Additional relevant MeSH terms:

Neoplasms

Neoplastic Processes

Pathologic Processes

Growth Substances

Vitamins

Physiological Effects of Drugs

Bone Density Conservation Agents

Micronutrients

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008

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