Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands

Kidney Failure, Chronic Clinical Trial

Official title:

Post-marketing Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Paricalcitol i.v. in the Treatment of Chronic Kidney Disease (CKD) 5 Stage Patients With (Severe) Secondary Hyperparathyroidism in Hungary

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01273597
• Other study ID #: P12-644
• Status: Completed
• Phase: N/A
• First received: November 22, 2010
• Last updated: January 11, 2013
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Scientific and Medical Research Council Ethics Committee
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the clinical benefit of Zemplar (paricalcitol injection) in daily routine practice in end-stage renal disease patients with severe over-reactivity of parathyroid glands. Participants will be followed for 6 months. Data will be collected from participants initiated on Zemplar therapy according to standard of care. The time to achieving the maintenance dose of Zemplar (paricalcitol injection), the proportion of participants achieving target parathyroid hormone levels, and prevalence of elevated serum calcium and phosphate levels will be evaluated.

Description:

Prospective data collection started at initial dosing with Zemplar (paricalcitol injection) and ended up to 6 months later. If available, retrospective data on vitamin D treatment as well as on the incidence of hypercalcaemia and hyperphosphataemia in the 6 months leading up to paricalcitol treatment were also collected. Eight visits were planned for documentation of prospective data. In accordance with the non-interventional character of the study, only diagnostic and monitoring procedures were applied which are part of the routine medical care of secondary hyperparathyroidism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Based on the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection), the patient is entitled to treatment with paricalcitol injection and:

1. = 18 years of age,

2. Willing to sign the patient information and informed consent form,

3. Chronic kidney disease (CKD) stage 5 patient receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT), whose intact parathyroid hormone (iPTH) level is:

• between 500-800 pg/mL with at least two abruption of conventional vitamin D therapy due to elevated serum calcium level (i.e. > 2.4 mmol/L) in the medical history, or

• higher than 800 pg/mL and parathyroidectomy is contraindicated.

4. The patient is planned to receive paricalcitol treatment independently from his/her participation in this study.

Exclusion Criteria:

Patients cannot be enrolled in the study if any of the following exclusion criteria apply:

1. The patient is already treated with Zemplar (paricalcitol injection),

2. Any contraindication exists as stated in the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection),

3. Patients who decline to participate in the study or decline to sign the patient information/informed consent form.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperparathyroidism
• Kidney Failure, Chronic
• Renal Insufficiency

Locations

Country	Name	City	State
Hungary	Site Reference ID/Investigator# 46585	Budapest
Hungary	Site Reference ID/Investigator# 46593	Budapest
Hungary	Site Reference ID/Investigator# 46594	Debrecen
Hungary	Site Reference ID/Investigator# 47722	Gyor
Hungary	Site Reference ID/Investigator# 46592	Karcag
Hungary	Site Reference ID/Investigator# 58644	Karcag
Hungary	Site Reference ID/Investigator# 46595	Miskolc
Hungary	Site Reference ID/Investigator# 46588	Nyiregyhaza
Hungary	Site Reference ID/Investigator# 46597	Pecs
Hungary	Site Reference ID/Investigator# 46590	Szombathely
Hungary	Site Reference ID/Investigator# 46591	Veszprem

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	Planimeter Ltd

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)	Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.	6 months	No
Secondary	Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6	Target intact parathyroid hormone (iPTH) values were within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.	6 months	No
Secondary	Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance	If available, data on vitamin D treatment (those who received vitamin D supplement products from Anatomical Therapeutic Chemical [ATC] group A11CC [vitamin D and analogues]) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.	6 months prior to start of study through 6 months of treatment	No
Secondary	Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance	If available, data on the use of phosphate binders (those who received calcium-based phosphate binders or sevelamer/lanthanum) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.	6 months prior to start of study through 6 months of treatment	No
Secondary	Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism	If available, data on the use of medication affecting secondary hyperparathyroidism (those who received calcimimetics and calcium supplementation) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.	6 months prior to start of study through 6 months of treatment	No
Secondary	Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy	Hypercalcaemia (serum calcium > 2.6 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).	6 months prior to start of study through baseline	No
Secondary	Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment	Hypercalcaemia (serum calcium > 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).	6 months	No
Secondary	Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy	Hyperphosphataemia (serum phosphorus >1.78 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).	6 months prior to start of study through baseline	No
Secondary	Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment	Hyperphosphataemia (serum phosphorus > 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).	6 months	No

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