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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01081665 |
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Date of registration:
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27/02/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
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Scientific title:
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A Two-year, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Haemodialysis, Receiving Zemplar for Prevention and Treatment of Secondary Hyperparathyroidism |
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Date of first enrolment:
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December 2006 |
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Target sample size:
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237 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01081665 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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Konstantinos Xynos, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Abbott Laboratories Hellas S.A. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject is >= 18 years of age and diagnosed with secondary hyperparathyroidism and a
pretreatment iParathormone > 300 pg/mL.
- Subject is receiving chronic hemodialysis.
- Subject for which treatment with Zemplar Injection is indicated clinically according
to the criteria of participating investigator.
- Subject has provided their informed consent to participate.
Exclusion Criteria:
- Subject has a corrected serum calcium > 10.5 mg/dL, serum phosphorus >= 6.5 mg/dL or
subjects with corrected Ca x P >= 65 mg^2/dl^2.
- Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or
other product ingredients.
- Subject has participated in clinical study within the last month.
- Zemplar is contraindicated according to the Summary of Product Characteristics.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Secondary Hyperparathyroidism
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Chronic Kidney Failure
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Primary Outcome(s)
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Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized
[Time Frame: Baseline to Month 24 Visit]
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Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
[Time Frame: Baseline to Month 24 Visit]
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Secondary Outcome(s)
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The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product
[Time Frame: Baseline to Month 24 Visit]
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The Incidence of Clinically Significant Hyperphosphatemia
[Time Frame: Baseline to Month 24 Visit]
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The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)
[Time Frame: Baseline to Month 24 Visit]
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To Estimate the Incidence of (S)AEs/(S)ADRs
[Time Frame: Baseline to Month 24 Visit]
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The Incidence of Clinically Significant Hypercalcemia
[Time Frame: Baseline to Month 24 Visit]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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