Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)
The aim of this post-marketing observational study (PMOS) is to provide data on the tolerability and compliance of treatment with Zemplar capsules in the therapy of secondary hyperparathyroidism in patients with chronic kidney disease stage 3 or 4 in conditions of routing clinical practice.
To evaluate the time period needed for achievement of > 30% decrease of Intact Parathyroid Hormone compared to the initial values.
Chronic Kidney Disease
|Official Title:||Evaluation of Treatment With Zemplar Cps in the Therapy of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) Stage 3 or 4 in the Conditions of Routine Clinical Practice. A Multi-country, Multi-center Post Marketing Observational Study in Routine Clinical Use in Eastern European Countries.|
- Time Period needed for the achievement of > 30 % decrease of Intact Parathyroid Hormone compared to baseline value [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of patients who achieved the main treatment goal => 30% decrease of Intact Parathyroid Hormone compared to the baseline value [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- The percentage of patients with the product of Calcium x Phosphorus > 65 mg2/dl2 or 5.24 mmol2/l2 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of patients with hypercalcemia = Calcium > 2.6 mmol/l (10.5 mg/dL) for describing of effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Total dose of Zemplar capsules taken will describe the compliance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Collection, assessment and processing of adverse events (AEs) will describe the tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2010|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Chronic kidney disease and secondary hyperparathyroidism
Chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism
This is a non-interventional, observational, open-label, multi-country, multicenter post-marketing study in which Zemplar is prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication.
The assignment of the patient to the treatment with Zemplar is not decided in advance by this protocol but falls within current practice. The prescription of Zemplar is clearly separated from the decision to include the patient in this study. No additional procedures (other than standard of care) shall be applied to the patients.
It is planned to enroll approximately 1,000 pts in total. A patient may only be enrolled in the study once.
All patient data entered in the patient case report form (CRF) will be forwarded - without naming the patient - for evaluation to AbbVie. In order to maintain patient confidentiality, instead of date of birth, the year of birth will be documented in the CRF.
The patients must provide authorization to the investigator to use and/or disclose personal and/or health data before entry into post marketing observational study according to Local Law requirements.
Medical doctors with experience in treatment of patients with chronic kidney disease stage 3 or 4 and secondary hyperparathyroidism will observe each enrolled patient for a period of 12 month.
Follow-up of patients should enable 6 patient visits during this period. At Screening Visit the decision for Zemplar capsules therapy will be made. Second Visit will occur after one month from the Screening Visit. Third Visit of patient will occur after 3 months of the treatment of the patient. Fourth Visit of patient will occur after 6 months of the beginning of the study, the Fifth Visit after 9 months of the study and the Sixth Visit of the patient will take place after 12 months of the treatment. This will be a Final Visit. Visits will be defined as V1, V2, V3, V4, V5, and V6. The physician can change numbers and time of the visits. As a result, failure to meet these suggested dates will not constitute a breach of the protocol.
Timing of visits and date collection is at the discretion of the prescribing physician.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224782
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|Study Director:||Corina Ionescu, MD||AbbVie|