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

NCT ID: NCT00537979

Last Updated: 2011-10-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Secondary Hyperparathyroidism Dialysis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paricalcitol injection

ABT-358 Zemplar

Group Type ACTIVE_COMPARATOR

Paricalcitol injection

Intervention Type DRUG

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

ABT-358 Zemplar

Group Type ACTIVE_COMPARATOR

Paricalcitol capsules

Intervention Type DRUG

Most recent iPTH level in pg/mL divided by 80 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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ABT-358 paricalcitol Zemplar ABT-358 paricalcitol Zemplar

Eligibility Criteria

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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
* Patients who cannot tolerate or take phosphorus binders that do not contain Calcium and/or Aluminum
* Patients that in the opinion of the investigator, for any reason, are not good candidates for therapy with Synthetic Analogues of Vitamin D
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose-Luis Cañadas, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Ref # / Investigator 19391

Jojutla Morelos, , Mexico

Site Status

Site Ref # / Investigator 19392

Mexico City, , Mexico

Site Status

Site Ref # / Investigator 19397

Mexico City, , Mexico

Site Status

Site Ref # / Investigator 19396

Mexico City, , Mexico

Site Status

Site Ref # / Investigator 19389

Mexico City, , Mexico

Site Status

Site Ref # / Investigator 19390

Mexico City, , Mexico

Site Status

Site Ref # / Investigator 19393

Mexico City, , Mexico

Site Status

Site Ref # / Investigator 19394

Mexico City, , Mexico

Site Status

Site Ref # / Investigator 19395

Mexico City, , Mexico

Site Status

Site Ref # / Investigator 19399

Puebla City, , Mexico

Site Status

Site Ref # / Investigator 19398

Zapopan, , Mexico

Site Status

Site Ref # / Investigator 19388

Zapopan, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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W10-129

Identifier Type: -

Identifier Source: org_study_id