Clinical Trial: Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Prospective, Open-label, Multicenter Effectiveness and Safety Observational Study of Zemplar in Patients With Stage 5 Chronic Kidney Disease and Hyperparathyroidism on Hemodialysis in the Russian Fede

Brief Summary: Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Planned therapy will be six months. Participants with Stage 5 Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into the study. Ability of Zemplar, (paricalcitol) to lower intact Parathyroid Hormone level will be assessed during the study.

Detailed Summary:

Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Study drug will be administered per local prescribing guidelines. Planned therapy is six months. Intact Parathyroid Hormone will be measured at the Screening visit. All participants who meet the inclusion criteria and fail to meet the exclusion criteria will be included in the study.

Adverse events will be monitored throughout the observation period (and up to 30 days after the last dose of Zemplar).

Ability of Zemplar to lower intact Parathyroid Hormone level will be assessed throughout the study. Proportion of participants with the level of intact Parathyroid Hormone 150 - 300 pg/mL was stated as primary endpoint. Calcium and Phosphorus elevation will be also measured throughout the study.

The selected population is representative in relation to those who will take Zemplar in routine practice. Participants with contraindications to Zemplar therapy (as per the local label) will not be included in the study.


Sponsor: AbbVie (prior sponsor, Abbott)

Current Primary Outcome: The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study [ Time Frame: 6 months ]

The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded.


Original Primary Outcome: The proportion of patients who have reached a target level of iPTH (150-300 pg/mL) at least once during the program period [ Time Frame: 6 months ]

Current Secondary Outcome:

  • Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study [ Time Frame: 6 months ]
    The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded.
  • Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study [ Time Frame: 6 months ]
    The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded.
  • Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study [ Time Frame: 6 months ]
    The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at least once post-baseline during the study was recorded.
  • Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study [ Time Frame: 6 months ]
    The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at each visit post-baseline during the study was recorded.
  • Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study [ Time Frame: 6 months ]
    The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at least once post-baseline during the study was recorded.
  • Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study [ Time Frame: 6 months ]
    The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at each visit post-baseline during the study was recorded.
  • Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination [ Time Frame: 6 months ]

    The percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded.

    Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks.



Original Secondary Outcome:

  • Proportion of patients who have reached the Kidney Disease Improving Global Outcomes target level of iPTH (2 times to 9 times upper limit of normal) at least once during the observation period [ Time Frame: 6 months ]
  • Proportion of patients who have reached the Kidney Disease Improving Global Outcomes target level at each month [ Time Frame: 6 months ]
  • Proportion of patients who have developed elevated Ca x P (> 75 mg2/dL2) at least once during the observation period [ Time Frame: 6 months ]
  • Proportion of patients who have developed elevated Ca x P (> 75 mg2/dL2) at ) at each month [ Time Frame: 6 months ]
  • Proportion of patients who have developed elevated normalized total calcium (> 11.2 mg/dL) at least once during the observation period [ Time Frame: 6 months ]
  • Proportion of patients who have developed elevated normalized total calcium (> 11.2 mg/dL) at each month [ Time Frame: 6 months ]
  • Proportion of patients who have developed hypercalcemia and hyperphosphatemia leading to study termination [ Time Frame: 6 months ]


Information By: AbbVie

Dates:
Date Received: July 22, 2011
Date Started: July 2011
Date Completion:
Last Updated: February 28, 2014
Last Verified: February 2014