Clinical trial NCT01081665: Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Failure
Secondary Hyperparathyroidism
Keywords: Chronic Kidney Failure
Secondary Hyperparathyroidism
Paricalcitol IV treatment
Safety and efficacy assessment
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-03-05
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis patients with secondary hyperparathyoidism treated with IV Paricalcitol according to the approved Summary of Product Characteristics

Brief summary: The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Greece.

Detailed description: The primary objective of this study is to evaluate the safety of Zemplar® in the treatment of Secondary hyperparathyroidism (iParathormone\>300 pg/mL) in subjects on hemodialysis treated in conditions of usual clinical care.

The primary safety endpoints of this study are to evaluate the safety of Zemplar by recording the number of hospitalizations and days hospitalized.

A secondary efficacy endpoint will be the proportion of subjects achieving therapeutic success. Therapeutic success with Zemplar® will be defined as:

* 40% reduction in the base iPTH level is achieved, and/or;
* serum iParathormone level \< 300 pg/mL.

Additional secondary endpoints are the incidence (proportion of patients) of clinically meaningful hypercalcemia (defined as corrected serum calcium (Ca) \> 11.0 mg/dL taken at 2 consecutive measurements), hyperphosphatemia (defined as serum phosphorous (P)\>6.5 mg/dL taken at 2 consecutive measurements), and elevated Ca x P product (defined as serum Ca x P\>65 mg\^2/dL\^2 taken at 2 consecutive measurements). Safety also will be assessed through adverse event monitoring and evaluation of laboratory variables and vital signs.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
timeFrame: Baseline to Month 24 Visit
measure: Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized
timeFrame: Baseline to Month 24 Visit
Secondary outcomes:
measure: The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)
timeFrame: Baseline to Month 24 Visit
measure: The Incidence of Clinically Significant Hypercalcemia
timeFrame: Baseline to Month 24 Visit
measure: The Incidence of Clinically Significant Hyperphosphatemia
timeFrame: Baseline to Month 24 Visit
measure: The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product
timeFrame: Baseline to Month 24 Visit
measure: To Estimate the Incidence of (S)AEs/(S)ADRs
timeFrame: Baseline to Month 24 Visit
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 32055
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 32050
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 32051
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 32049
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 5283
city: Chalkida
country: Greece
facility: Site Reference ID/Investigator# 32056
city: Chania
country: Greece
facility: Site Reference ID/Investigator# 32057
city: Drama
country: Greece
facility: Site Reference ID/Investigator# 32058
city: Holargos
country: Greece
facility: Site Reference ID/Investigator# 32077
city: Katerini
country: Greece
facility: Site Reference ID/Investigator# 32076
city: Kavala
country: Greece
facility: Site Reference ID/Investigator# 32059
city: Komotini
country: Greece
facility: Site Reference ID/Investigator# 32053
city: Lamia
country: Greece
facility: Site Reference ID/Investigator# 32060
city: Lefkada
country: Greece
facility: Site Reference ID/Investigator# 32061
city: Livadia
country: Greece
facility: Site Reference ID/Investigator# 32062
city: Pireus
country: Greece
facility: Site Reference ID/Investigator# 32048
city: Preveza
country: Greece
facility: Site Reference ID/Investigator# 32054
city: Ptolemaida
country: Greece
facility: Site Reference ID/Investigator# 32063
city: Volos
country: Greece
facility: Site Reference ID/Investigator# 32075
Study officials:
affiliation: Abbott Laboratories Hellas S.A.
name: Konstantinos Xynos, MD
role: STUDY_CHAIR
References: