Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
|ClinicalTrials.gov Identifier: NCT01081665|
Recruitment Status : Completed
First Posted : March 5, 2010
Results First Posted : March 12, 2012
Last Update Posted : March 27, 2012
|Condition or disease|
|Chronic Kidney Failure Secondary Hyperparathyroidism|
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.
|Study Type :||Observational|
|Actual Enrollment :||237 participants|
|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 Start Date :||December 2006|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
Chronic Kidney Disease
All eligible patients treated with IV Paricalcitol (Zemplar)
- Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations [ Time Frame: Baseline to Month 24 Visit ]The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.
- Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized [ Time Frame: Baseline to Month 24 Visit ]The mean (average) number of days hospitalized per participant for those hospitalized during the study.
- The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml) [ Time Frame: Baseline to Month 24 Visit ]Therapeutic success of paricalcitol treatment was defined as a 40% decrease from the baseline measurement in the level of intact parathyroid hormone (also known as iPTH or parathormone) and/or a serum intact parathyroid hormone level less than 300 picograms per milliliter (pg/mL) for at least 2 consecutive available measurements during the 24-month follow-up period.
- The Incidence of Clinically Significant Hypercalcemia [ Time Frame: Baseline to Month 24 Visit ]The number of participants with clinically significant hypercalcemia (too much calcium in the blood), defined as a corrected serum calcium level greater than 11.0 milligrams per deciliter (mg/dL) at 2 consecutive measurements.
- The Incidence of Clinically Significant Hyperphosphatemia [ Time Frame: Baseline to Month 24 Visit ]The number of participants with clinically significant hyperphosphatemia (too much phosphorous in the blood), defined as serum phosphorous levels greater than 6.5 milligrams per deciliter (mg/dL) at 2 consecutive measurements.
- The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product [ Time Frame: Baseline to Month 24 Visit ]The number of participants with clinically significant levels of calcium-phosphorous product (Ca x P), defined as serum calcium-phosphorous product levels greater than 65 milligrams squared per deciliters squared (mg^2/dL^2) at 2 consecutive measurements.
- To Estimate the Incidence of (S)AEs/(S)ADRs [ Time Frame: Baseline to Month 24 Visit ]The number of adverse events, serious adverse events (including death), adverse drug reactions, and serious adverse drug reactions experienced by participants during the study are summarized. Adverse events include any events reported regardless of whether or not they were considered related to the study drug. Adverse drug reactions include events where a causal relationship between the drug and the occurence of the event is suspected. For additional details see the Reported Adverse Events section.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081665
|Site Reference ID/Investigator# 32055|
|Athens, Greece, 11526|
|Site Reference ID/Investigator# 32050|
|Athens, Greece, 11528|
|Site Reference ID/Investigator# 32051|
|Athens, Greece, 11528|
|Site Reference ID/Investigator# 32049|
|Athens, Greece, 17237|
|Site Reference ID/Investigator# 5283|
|Site Reference ID/Investigator# 32056|
|Chalkida, Greece, 34100|
|Site Reference ID/Investigator# 32057|
|Chania, Greece, 73100|
|Site Reference ID/Investigator# 32058|
|Drama, Greece, 66100|
|Site Reference ID/Investigator# 32077|
|Holargos, Greece, 15562|
|Site Reference ID/Investigator# 32076|
|Katerini, Greece, 60100|
|Site Reference ID/Investigator# 32059|
|Kavala, Greece, 65201|
|Site Reference ID/Investigator# 32053|
|Komotini, Greece, 69100|
|Site Reference ID/Investigator# 32060|
|Lamia, Greece, 35100|
|Site Reference ID/Investigator# 32061|
|Lefkada, Greece, 31100|
|Site Reference ID/Investigator# 32062|
|Livadia, Greece, 32100|
|Site Reference ID/Investigator# 32048|
|Site Reference ID/Investigator# 32054|
|Preveza, Greece, 48100|
|Site Reference ID/Investigator# 32063|
|Ptolemaida, Greece, 50200|
|Site Reference ID/Investigator# 32075|
|Volos, Greece, 38222|
|Study Chair:||Konstantinos Xynos, MD||Abbott Laboratories Hellas S.A.|