Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience (PROTECT)

AbbVie

Status: Completed

Conditions: Chronic Kidney Failure; Secondary Hyperparathyroidism

Study type: Observational

Funder types: Industry

Identifiers

NCT01083186

P11-978

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism

Description:

Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)