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NCT Number: NCT00537979

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

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.

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Key information

Conditions

Secondary Hyperparathyroidism Dialysis Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Site Ref # / Investigator 19391, Jojutla Morelos, Mexico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paricalcitol injection

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

Other names: ABT-358, paricalcitol, Zemplar

Paricalcitol capsules

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

Other names: ABT-358, paricalcitol, Zemplar

Primary outcomes

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

    Time frame: 24 weeks

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

Secondary outcomes

  1. 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

    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.

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

    Time frame: 24 weeks

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

  3. 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

    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%.

  4. Duration of Response to Treatment

    Time frame: 24 weeks

    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.

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

    Time frame: Baseline and 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 2, 2007
Registry last updated
Oct 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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