Clinical trial NCT01083186: Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience
Official title: Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Failure
Secondary Hyperparathyroidism
Keywords: Secondary Hyperparathyroidism
Chronic Kidney Failure
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-03-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from 24 hospital-based specialty, nephrology clinics in Greece

Brief summary: The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and secondary hyperparathyroidism.

Detailed description: This was a single arm, open, multicenter, non-interventional, post marketing observational study, which has been conducted in 24 sites in Greece, under normal clinical practice and as per the locally approved Summary of Product Characteristics (SmPC) of study medication (oral paricalcitol). Eligible patients were followed up for a 12-month period after enrollment. All study activities were consistent with European Union (EU) directive 2001/20/EC section for non-interventional studies.

In this study, paricalcitol was prescribed on an on-label basis in an everyday setting to observe drug actions in a distinct geography (Greece with \> 250 days/year of sunny days) as well as in a significant subpopulation (Chronic Kidney Disease \[CKD\] stages 3-5 transplanted patients). Dose tolerability, treatment effects, as well as maintenance of results were registered for a 12-month period in order to obtain experience in the long term use of paricalcitol capsules. Furthermore, in centers where additional blood parameters were examined as part of clinical routine, these were recorded and analyzed.

Eligibility criteria: Inclusion Criteria:

* Patients with secondary hyperparathyroidism in the presence of chronic kidney disease stage 3, 4 or 5 treated with Zemplar (paricalcitol) oral for at least 1 month prior to study enrollment
* Male and female (not pregnant or not planning to be pregnant in the next 12 months) patients \> 18 years of age
* Signed informed consent by subject
* Hypertensive and diabetic subjects must be on an optimal and steady medication regimen for more than 30 days

Exclusion Criteria:

* Contraindications listed in the Summary of Product Characteristics for Zemplar capsules apply (Appendix I and II)
* Parathormone value of \> 1000 pg/mL (sign of tertiary hyperparathyroidism)
* Treatment with Vitamin D within the last 1 month prior to inclusion into the study

Primary outcomes:
measure: Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population
timeFrame: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12
measure: Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants
timeFrame: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12
Secondary outcomes:
measure: Median Time to Attain the First Lower Intact Parathormone (iPTH) Levels
timeFrame: Measured from start of study, up to a maximum of 12 months
measure: Mean Duration of Effect Sustainability (Months)
timeFrame: Measured from start of study, up to a maximum of 12 months
measure: Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range
timeFrame: Enrollment Visit, Month 3, Month 6, Month 9, Month 12
measure: Number of Participants With Serum Calcium Level Abnormalities
timeFrame: Baseline, Enrollment Visit, Month 6, Month 12
measure: Number of Participants With Serum Phosphorus Level Abnormalities
timeFrame: Baseline, Enrollment Visit, Month 6, Month 12
measure: Change in Dipstick Albuminuria Grade From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: Change in Dipstick Albuminuria Grade From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study
timeFrame: Baseline, Enrollment Visit, Month 6, Month 12
measure: Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs)
timeFrame: From time of enrollment throughout the study up to 12 months for nSAEs. SAEs from time of enrollment throughout the study up to + 30 days after end of study.
measure: Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study
timeFrame: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12
measure: Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study
timeFrame: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12
measure: Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12
timeFrame: Baseline, Month 6, Month 12
measure: Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12
timeFrame: Baseline, Month 6, Month 12
measure: Change From Baseline in Creatinine Levels at Months 6 and 12
timeFrame: Baseline, Month 6, Month 12
measure: Change From Baseline in Urea Levels at Months 6 and 12
timeFrame: Baseline, Month 6, Month 12
measure: Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12
timeFrame: Baseline, Month 6, Month 12
measure: Change From Enrollment in Total Cholesterol Levels at Months 6 and 12
timeFrame: Enrollment, Month 6, Month 12
measure: Change From Enrollment in Triglyceride Levels at Months 6 and 12
timeFrame: Enrollment, Month 6, Month 12
measure: Change From Enrollment in Low Density Lipoprotein Cholesterol (LDL-C) Levels at Months 6 and 12
timeFrame: Enrollment, Month 6, Month 12
measure: Change From Enrollment in High Density Lipoprotein Cholesterol (HDL-C) Levels at Months 6 and 12
timeFrame: Enrollment, Month 6, Month 12
measure: Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12
timeFrame: Baseline, Month 6, Month 12
measure: Homocysteine Values Throughout the Study
timeFrame: Baseline, Enrollment Visit, Month 6, Month 12
Other outcomes:
Locations:
city: Arta
country: Greece
facility: Site Reference ID/Investigator# 47002
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 43772
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 27492
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 43769
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 38257
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 47003
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 27497
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 47004
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 27489
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 27495
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 43773
city: Haidari, Athens
country: Greece
facility: Site Reference ID/Investigator# 27498
city: Ioannina
country: Greece
facility: Site Reference ID/Investigator# 38259
city: Larissa
country: Greece
facility: Site Reference ID/Investigator# 22121
city: Larissa
country: Greece
facility: Site Reference ID/Investigator# 43771
city: Maroussi Athens
country: Greece
facility: Site Reference ID/Investigator# 43767
city: Nikaia
country: Greece
facility: Site Reference ID/Investigator# 27496
city: North Ionia, Athens
country: Greece
facility: Site Reference ID/Investigator# 43768
city: Piraeus
country: Greece
facility: Site Reference ID/Investigator# 27491
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 27494
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 27493
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 38255
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 43770
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 39839
Study officials:
affiliation: AbbVie Pharmaceuticals S.A.
name: Christos Argyropoulos, MD
role: STUDY_DIRECTOR
References: