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

Abbott147 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

147

Conditions

Secondary Hyperparathyroidism Dialysis

Interventions

Paricalcitol injectionDRUG

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 capsulesDRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Site Ref # / Investigator 19391

Jojutla Morelos, Mexico

Site Ref # / Investigator 19392

Mexico City, Mexico

Site Ref # / Investigator 19397

Mexico City, Mexico

Outcomes

Primary Outcomes

Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level

Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level.

Time frame: 24 weeks

Secondary Outcomes

Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75)

Number of participants with hypercalcemia (calcium levels greater than 11.5 mg/dL), hyperphosphatemia (phosphorus levels greater than 7.0 mg/dL), or calcium x phosphorus product levels greater than 75.

Time frame: 24 Weeks

Proportion of Subjects Who Achieve an iPTH <300 pg/mL

Number of participants who achieved an intact parathyroid hormone (iPTH) level of less than 300 pg/mL.

Time frame: 24 weeks

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

Number of days required to achieve a reduction in intact parathyroid hormone (iPTH) to less than 300 pg/mL, a reduction in iPTH of greater than or equal to 50%, or either a reduction in iPTH to less than 300 pg/mL or a reduction in iPTH of greater than or equal to 50%.

Time frame: 24 weeks

Duration of Response to Treatment

Time in days between 2 consecutive visits with a reduction in intact parathyroid hormone (iPTH) of greater than or equal to 50% from the baseline visit.

Time frame: 24 weeks

Health-related Quality of Life With Paricalcitol Injection or Oral Treatment

Data from ClinicalTrials.gov

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