Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01081665

Enrollment

237

Registered

2010-03-05

Start date

2006-12-31

Completion date

2011-02-28

Last updated

2012-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Failure, Secondary Hyperparathyroidism

Keywords

Chronic Kidney Failure, Secondary Hyperparathyroidism, Paricalcitol IV treatment, Safety and efficacy assessment

Brief summary

The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Greece.

Detailed description

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject is \>= 18 years of age and diagnosed with secondary hyperparathyroidism and a pretreatment iParathormone \> 300 pg/mL. * Subject is receiving chronic hemodialysis. * Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator. * Subject has provided their informed consent to participate.

Exclusion criteria

* Subject has a corrected serum calcium \> 10.5 mg/dL, serum phosphorus \>= 6.5 mg/dL or subjects with corrected Ca x P \>= 65 mg\^2/dl\^2. * Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients. * Subject has participated in clinical study within the last month. * Zemplar is contraindicated according to the Summary of Product Characteristics.

Design outcomes

Primary

Measure	Time frame	Description
Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations	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	Baseline to Month 24 Visit	The mean (average) number of days hospitalized per participant for those hospitalized during the study.

Secondary

Measure	Time frame	Description
The Incidence of Clinically Significant Hyperphosphatemia	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 Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)	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.
To Estimate the Incidence of (S)AEs/(S)ADRs	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.
The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product	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.
The Incidence of Clinically Significant Hypercalcemia	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.

Countries

Greece

Participant flow

Participants by arm

Arm	Count
Chronic Kidney Disease All eligible patients treated with IV Paricalcitol (Zemplar)	237
Total	237

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Change in renal replacement therapy	2
Overall Study	Change of dialysis unit	10
Overall Study	Death	41
Overall Study	Lack of Efficacy	1
Overall Study	Lost to Follow-up	18
Overall Study	Regulation of iPTH	5
Overall Study	Withdrawal by Subject	17

Baseline characteristics

Characteristic	Chronic Kidney Disease
Age at chronic kidney disease diagnosis	53.6 years STANDARD_DEVIATION 14.7
Age Continuous	62.6 years STANDARD_DEVIATION 13.7
Region of Enrollment Greece	237 participants
Sex: Female, Male Female	110 Participants
Sex: Female, Male Male	127 Participants
Time since chronic kidney disease diagnosis	8.8 years STANDARD_DEVIATION 6.8
Time since diagnosis of secondary hyperparathyroidism	2.0 years STANDARD_DEVIATION 3.1
Time since starting haemodialysis	3.6 years STANDARD_DEVIATION 4.4

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	170 / 237
serious Total, serious adverse events	94 / 237

Outcome results

Primary

Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized

The mean (average) number of days hospitalized per participant for those hospitalized during the study.