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Postmarketing Observational Study to Evaluate the Effect of Zemplar (Paricalcitol IV) on Cardiac Morbidity in Patients With Chronic Kidney Disease Stage 5 Over 2 Years.
The purpose of this study was to ascertain the percentage of cardiac patients with chronic kidney disease (CKD) stage 5 treated with paricalcitol IV achieving intact parathyroid hormone (iPTH) levels in target range of Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines (150 - 300 pg/mL) after 2 years.
Details
| Lead sponsor | AbbVie (prior sponsor, Abbott) |
|---|---|
| Status | COMPLETED |
| Enrolment | 67 |
| Start date | 2008-12 |
| Completion | 2013-06 |
Conditions
- Secondary Hyperparathyroidism
- Chronic Kidney Disease Stage V
- Cardiac Morbidity
Primary outcomes
- Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range — Baseline and Months 3, 6, 12, 18, and 24
Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 - 31.8 pmol/L (150 to 300 pg/mL).
Countries
Austria