Neoplasms

Symptoms and General Pathology

All Conditions

Gland and Hormone Related Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Vitamins

Ergocalciferols

Hormones

Calcium

Calcium, Dietary

Trace Elements

Calciferol

Ergocalciferol

Vitamin D2

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 injection

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

Paricalcitol capsules

Jose-Luis Cañadas, MD

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.

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

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

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

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.

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

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 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.

Analysis of the differences before and after 24 weeks of treatment in various quality of life measurements for participants on hemodialysis receiving paricalcitol injection and participants on peritoneal dialysis receiving paricalcitol capsules.

Abbott

Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.

Paricalcitol Injection

Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.

Paricalcitol Capsules

Total

Age Continuous

Sex: Female, Male

Mexico

Region of Enrollment

Global Medical Services

The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.

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

Hypercalcemia

Hyperphosphatemia

Elevated calcium x phosphorus product

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

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

Time to achieve iPTH less than 300 pg/mL

Time to achieve 50% or greater reduction in iPTH

Time to achieve either

The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. For this outcome measure, the group evaluated included both participants on hemodialysis receiving paricalcitol injection and those on peritoneal dialysis receiving paricalcitol capsules.

Per-Protocol Population

The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.

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

Duration of Response to Treatment

Mobility-Baseline Score 1

Mobility-Baseline Score 2

Mobility-Baseline Score 3

Mobility-Final Score 1

Mobility-Final Score 2

Mobility-Final Score 3

Personal Care-Baseline Score 1

Personal Care-Baseline Score 2

Personal Care-Baseline Score 3

Personal Care-Final Score 1

Personal Care-Final Score 2

Personal Care-Final Score 3

Daily Activities-Baseline Score 1

Daily Activities-Baseline Score 2

Daily Activities-Baseline Score 3

Daily Activities-Final Score 1

Daily Activities-Final Score 2

Daily Activities-Final Score 3

Pain/Discomfort-Baseline Score 1

Pain/Discomfort-Baseline Score 2

Pain/Discomfort-Baseline Score 3

Pain/Discomfort-Final Score 1

Pain/Discomfort-Final Score 2

Pain/Discomfort-Final Score 3

Anxiety/Depression-Baseline Score 1

Anxiety/Depression-Baseline Score 2

Anxiety/Depression-Baseline Score 3

Anxiety/Depression-Final Score 1

Anxiety/Depression-Final Score 2

Anxiety/Depression-Final Score 3

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

Overall Study

Spots Global Cancer Trial Database for Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial