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

This study has been completed.
Sponsor:
Collaborator:
Almedis
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01401478
First received: July 22, 2011
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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.


Condition
Secondary Hyperparathyroidism

Study Type: Observational
Study Design: Time Perspective: Prospective
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 Federation

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 86
Study Start Date: July 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stage 5 Chronic Kidney Disease
Planned for Zemplar administration due to secondary hyperparathyroidism

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hemodialysis centers

Criteria

Inclusion Criteria:

  1. Age 18-65 years
  2. Chronic Kidney Disease stage 5 receiving hemodialysis
  3. Authorization (Consent) for Use/Disclosure of Data signed by the patient
  4. Planned prescription of Zemplar treatment due to fair clinical need and irrespectively of the participation in the current program according to the local label within 2 weeks after screening into the program
  5. Screening intact Parathyroid Hormone level (measured not earlier than 1 month before first dose of Zemplar) between 300 and 900 pg/mL

Exclusion Criteria:

  1. Contraindications to Zemplar as indicated in approved label, including but not limited to hypersensitivity, hypervitaminosis D (serum D3 level above 32 ng/mL), concomitant use of vitamin D or phosphates, lactation period, pregnancy
  2. Any experimental drug within the period of 30 days before the inclusion into the program
  3. Screening Ca x P > 65 mg˄2/dL˄2
  4. Screening normalized serum total calcium > 10.2 mg/dL
  5. Necessity for calcitonin maintenance oral or intravenous glucocorticoids, or other drugs that could have affected calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401478

Locations
Russian Federation
Site Reference ID/Investigator# 57348
Almetyevsk, Russian Federation, 423450
Site Reference ID/Investigator# 57347
Cheboksary, Russian Federation, 428018
Site Reference ID/Investigator# 58347
Chelyabinsk, Russian Federation, 454076
Site Reference ID/Investigator# 67404
Iakutsk, Russian Federation, 677019
Site Reference ID/Investigator# 57344
Irkutsk, Russian Federation, 664079 RF
Site Reference ID/Investigator# 57346
Kazan, Russian Federation, 420045
Site Reference ID/Investigator# 58356
Moscow, Russian Federation, 125284
Site Reference ID/Investigator# 58348
Moscow, Russian Federation, 127015
Site Reference ID/Investigator# 57342
Novosibirsk, Russian Federation, 630120
Site Reference ID/Investigator# 57364
Orenburg, Russian Federation, 460040
Site Reference ID/Investigator# 69687
Samara, Russian Federation, 443095
Site Reference ID/Investigator# 57363
St. Petersburg, Russian Federation, 191104
Site Reference ID/Investigator# 69688
Ulan-Ude, Russian Federation, 670031
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Almedis
Investigators
Study Director: Andrey Strugovshchikov, MD AbbVie LLC
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01401478     History of Changes
Other Study ID Numbers: P12-838
Study First Received: July 22, 2011
Results First Received: January 14, 2014
Last Updated: February 28, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by AbbVie:
Secondary Hyperparathyroidism
Chronic Renal Insufficiency

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Hyperparathyroidism
Hyperparathyroidism, Secondary
Renal Insufficiency
Urologic Diseases
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014