Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01224782
First received: September 27, 2010
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

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.


Condition
Chronic Kidney Disease
Secondary Hyperparathyroidism

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 994
Study Start Date: October 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic kidney disease and secondary hyperparathyroidism
Chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Zemplar capsules will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not prescribe Zemplar capsules would be taken prior to entry of a subject in the study.

Medical doctors with experience in treatment of patients with chronic kidney disease (CKD) stage 3 or 4 and secondary hyperparathyroidism (SHPT) will observe each enrolled patient for a period of 12 month.

Follow-up of patients should enable 6 patient visits during this period.

Criteria

Inclusion Criteria:

  • 18 years old patients or older
  • Patients with chronic kidney disease (CKD) stage 3 and 4 and secondary hyperparathyroidism (SHPT)
  • Patients with Intact Parathyroid Hormone (iPTH) > 70 pg/ml and with chronic kidney disease (CKD) stage 3 or with Intact Parathyroid Hormone (iPTH) > 110 pg/ml and with chronic kidney disease (CKD) stage 4
  • Patients clinically indicated for the treatment with Zemplar capsules
  • Patient must provide the authorization to use his/her data for statistical evaluation before entering to the post marketing observational study (PMOS). Local Law requirements to be followed

Exclusion Criteria:

  • Patients with clinically important hypercalcemia =Calcium> 2.6 mmol/l (10.5 mg/dL)
  • Patients suffering from proved intoxication of vitamin D or patient with known hypersensitivity to paricalcitol or any other part of the product
  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: NCT01224782

  Show 68 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Corina Ionescu, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01224782     History of Changes
Other Study ID Numbers: P12-269
Study First Received: September 27, 2010
Last Updated: October 17, 2013
Health Authority: Romania: Ethics Committee
Bulgaria: Ethics committee
Czech Republic: Ethics Committee

Keywords provided by AbbVie:
Zemplar capsules
Chronic kidney disease (CKD) stage 3 or 4
Secondary hyperparathyroidism (SHPT)
Postmarketing observational study (PMOS)

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

ClinicalTrials.gov processed this record on August 26, 2014