Study of Zemplar iv in Patients With End Stage Chronic Kidney Disease, Undergoing Haemodialysis
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|ClinicalTrials.gov Identifier: NCT01084538|
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : September 12, 2011
Last Update Posted : September 21, 2011
|Condition or disease||Intervention/treatment|
|Parathyroid Hormone||Drug: Zemplar iv (paricalcitol iv)|
|Study Type :||Observational|
|Actual Enrollment :||181 participants|
|Official Title:||A One-year, Multicountry, Multicenter Study of Zemplar Injections in Patients With End Stage Chronic Kidney Disease, Undergoing Hemodialysis, Not Adequately Controlled With Oral Vitamin D Receptor Activator (Calcitriol or Alfacalcidol)|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
End stage chronic kidney disease
Secondary hyperparathyroidism defined as intact PTH > 300 pg/mL
Drug: Zemplar iv (paricalcitol iv)
Each patient will be treated at the physician's discretion. Zemplar (paricalcitol) will be prescribed in the usual manner in accordance with the approved Summary of Product Characteristics.
Other Name: Zemplar iv
- Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline [ Time Frame: Baseline through 12 months ]
- Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL) [ Time Frame: Baseline through 12 months ]Percentage of subjects achieving a serum iPTH level less than or equal to 300 pg/mL on the final visit.
- Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL [ Time Frame: Baseline through 12 months ]The average time (measured in days) to achieve target iPTH levels.
- Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements. [ Time Frame: Baseline through 12 months ]Number of participants with clinically meaningful hypercalcemia, defined as corrected serum calcium greater than 11.0 milligrams per deciLiter (mg/dL) taken at two consecutive measurements (visits) during the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084538
|Study Director:||Marta Gunjaca, MD||Abbott|