Status:
COMPLETED
Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Almedis
Conditions:
Secondary Hyperparathyroidism
Eligibility:
All Genders
18-65 years
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 a...
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 s...
Eligibility Criteria
Inclusion
- Age 18-65 years
- Chronic Kidney Disease stage 5 receiving hemodialysis
- Authorization (Consent) for Use/Disclosure of Data signed by the patient
- 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
- Screening intact Parathyroid Hormone level (measured not earlier than 1 month before first dose of Zemplar) between 300 and 900 pg/mL
Exclusion
- 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
- Any experimental drug within the period of 30 days before the inclusion into the program
- Screening Ca x P \> 65 mg˄2/dL˄2
- Screening normalized serum total calcium \> 10.2 mg/dL
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT01401478
Start Date
July 1 2011
End Date
January 1 2013
Last Update
March 3 2014
Active Locations (13)
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1
Site Reference ID/Investigator# 57348
Al'met'yevsk, Russia, 423450
2
Site Reference ID/Investigator# 57347
Cheboksary, Russia, 428018
3
Site Reference ID/Investigator# 58347
Chelyabinsk, Russia, 454076
4
Site Reference ID/Investigator# 67404
Iakutsk, Russia, 677019