Clinical trial NCT01273597: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure, Chronic
Keywords: Parathyroid hormone,Kidney failure, chronic,Hyperparathyroidism, secondary
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Planimeter Ltd
First posted: 2011-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage 5 chronic kidney disease patients treated in haemodialysis centers in Hungary

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6
timeFrame: 6 months
measure: Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance
timeFrame: 6 months prior to start of study through 6 months of treatment
measure: Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance
timeFrame: 6 months prior to start of study through 6 months of treatment
measure: Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism
timeFrame: 6 months prior to start of study through 6 months of treatment
measure: Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy
timeFrame: 6 months prior to start of study through baseline
measure: Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
timeFrame: 6 months
measure: Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy
timeFrame: 6 months prior to start of study through baseline
measure: Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 46593
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 46585
city: Debrecen
country: Hungary
facility: Site Reference ID/Investigator# 46594
city: Gyor
country: Hungary
facility: Site Reference ID/Investigator# 47722
city: Karcag
country: Hungary
facility: Site Reference ID/Investigator# 46592
city: Karcag
country: Hungary
facility: Site Reference ID/Investigator# 58644
city: Miskolc
country: Hungary
facility: Site Reference ID/Investigator# 46595
city: Nyiregyhaza
country: Hungary
facility: Site Reference ID/Investigator# 46588
city: Pecs
country: Hungary
facility: Site Reference ID/Investigator# 46597
city: Szombathely
country: Hungary
facility: Site Reference ID/Investigator# 46590
city: Veszprem
country: Hungary
facility: Site Reference ID/Investigator# 46591
Study officials:
affiliation: AbbVie (prior sponsor, Abbott)
name: Tamas Schnaider
role: STUDY_DIRECTOR
References: