Clinical trial NCT00537979: Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis
Official title: Prospective, Non-randomized, Multicenter Study to Assess the Efficacy and Safety of Oral or Intravenous Paricalcitol Administered Over 6 Months to Patients With Secondary Hyperparathyroidism on Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Secondary Hyperparathyroidism
Dialysis
Keywords: Dialysis
Hyperparathyroidism
Zemplar
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2007-10-02
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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
* 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

Primary outcomes:
measure: Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level
timeFrame: 24 weeks
Secondary outcomes:
measure: Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75)
timeFrame: 24 Weeks
measure: Proportion of Subjects Who Achieve an iPTH <300 pg/mL
timeFrame: 24 weeks
measure: 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
timeFrame: 24 weeks
measure: Duration of Response to Treatment
timeFrame: 24 weeks
measure: Health-related Quality of Life With Paricalcitol Injection or Oral Treatment
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Jojutla Morelos
country: Mexico
facility: Site Ref # / Investigator 19391
city: Mexico City
country: Mexico
facility: Site Ref # / Investigator 19389
city: Mexico City
country: Mexico
facility: Site Ref # / Investigator 19390
city: Mexico City
country: Mexico
facility: Site Ref # / Investigator 19393
city: Mexico City
country: Mexico
facility: Site Ref # / Investigator 19395
city: Mexico D.F.
country: Mexico
facility: Site Ref # / Investigator 19392
city: Mexico D.F.
country: Mexico
facility: Site Ref # / Investigator 19397
city: Mexico D.F.
country: Mexico
facility: Site Ref # / Investigator 19396
city: Mexico D.F.
country: Mexico
facility: Site Ref # / Investigator 19394
city: Puebla
country: Mexico
facility: Site Ref # / Investigator 19399
city: Zapopan
country: Mexico
facility: Site Ref # / Investigator 19398
city: Zapopan
country: Mexico
facility: Site Ref # / Investigator 19388
Study officials:
affiliation: Abbott
name: Jose-Luis Cañadas, MD
role: STUDY_DIRECTOR
References: