N/A
N=86
Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation
Secondary Hyperparathyroidism
Bottom Line
View on ClinicalTrials.gov: NCT01401478 ↗Enrolled (actual)
86
Serious AEs
3.5%
Results posted
Feb 2014
Primary outcome: Primary: 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 — 60.5 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
60.5 | — |
| SECONDARY Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study |
57.0; 87.2 | — |
| SECONDARY Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study |
49.1; 65.5; 45.5; 67.3; 40.0; 41.8 | — |
| SECONDARY 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 |
38.4 | — |
| SECONDARY 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 |
12.8; 16.3; 16.3; 4.7; 7.0; 8.1 | — |
| SECONDARY Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study |
10.5 | — |
| SECONDARY Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study |
1.2; 2.3; 2.3; 4.7; 2.3; 0 | — |
| SECONDARY Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination |
0; 7.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01401478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.