Trial Outcomes & Findings for Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism (NCT NCT01081665)
NCT ID: NCT01081665
Last Updated: 2012-03-27
Results Overview
The mean (average) number of days hospitalized per participant for those hospitalized during the study.
Recruitment status
COMPLETED
Target enrollment
237 participants
Primary outcome timeframe
Baseline to Month 24 Visit
Results posted on
2012-03-27
Participant Flow
Participant milestones
| Measure |
Chronic Kidney Disease
All eligible patients treated with IV Paricalcitol (Zemplar)
|
|---|---|
|
Overall Study
STARTED
|
237
|
|
Overall Study
Full Analysis Set
|
237
|
|
Overall Study
Evaluable Population
|
212
|
|
Overall Study
COMPLETED
|
142
|
|
Overall Study
NOT COMPLETED
|
95
|
Reasons for withdrawal
| Measure |
Chronic Kidney Disease
All eligible patients treated with IV Paricalcitol (Zemplar)
|
|---|---|
|
Overall Study
Death
|
41
|
|
Overall Study
Lost to Follow-up
|
18
|
|
Overall Study
Withdrawal by Subject
|
17
|
|
Overall Study
Change of dialysis unit
|
10
|
|
Overall Study
Regulation of iPTH
|
5
|
|
Overall Study
Change in renal replacement therapy
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
Baseline characteristics by cohort
| Measure |
Chronic Kidney Disease
n=237 Participants
All eligible patients treated with IV Paricalcitol (Zemplar)
|
|---|---|
|
Age Continuous
|
62.6 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
237 participants
n=5 Participants
|
|
Age at chronic kidney disease diagnosis
|
53.6 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Time since chronic kidney disease diagnosis
|
8.8 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Time since starting haemodialysis
|
3.6 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Time since diagnosis of secondary hyperparathyroidism
|
2.0 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 24 VisitPopulation: Analysis included all enrolled participants.
The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.
Outcome measures
| Measure |
Chronic Kidney Disease
n=237 Participants
All eligible patients treated with IV Paricalcitol (Zemplar)
|
|---|---|
|
Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
Participants with no hospitalizations
|
152 participants
|
|
Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
Participants with at least 1 hospitalization
|
85 participants
|
|
Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
>Participants with 1 hospitalization
|
59 participants
|
|
Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
>Participants with 2 hospitalizations
|
16 participants
|
|
Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
>Participants with 3 or more hospitalizations
|
10 participants
|
PRIMARY outcome
Timeframe: Baseline to Month 24 VisitPopulation: Based on participant hospitalizations during the study where the length of hospitalization was known (82 participants total).
The mean (average) number of days hospitalized per participant for those hospitalized during the study.
Outcome measures
| Measure |
Chronic Kidney Disease
n=82 Participants
All eligible patients treated with IV Paricalcitol (Zemplar)
|
|---|---|
|
Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized
|
16.1 days
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: Baseline to Month 24 VisitPopulation: Analysis based on the evaluable population, defined as participants with baseline and at least 2 post-baseline parathormone measurements at the 24-month post-treatment follow-up 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.
Outcome measures
| Measure |
Chronic Kidney Disease
n=212 Participants
All eligible patients treated with IV Paricalcitol (Zemplar)
|
|---|---|
|
The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)
|
78.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Month 24 VisitPopulation: Analysis included all enrolled participants.
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.
Outcome measures
| Measure |
Chronic Kidney Disease
n=237 Participants
All eligible patients treated with IV Paricalcitol (Zemplar)
|
|---|---|
|
The Incidence of Clinically Significant Hypercalcemia
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 24 VisitPopulation: Analysis included all enrolled participants.
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.
Outcome measures
| Measure |
Chronic Kidney Disease
n=237 Participants
All eligible patients treated with IV Paricalcitol (Zemplar)
|
|---|---|
|
The Incidence of Clinically Significant Hyperphosphatemia
|
107 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 24 VisitPopulation: Analysis included all enrolled participants.
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.
Outcome measures
| Measure |
Chronic Kidney Disease
n=237 Participants
All eligible patients treated with IV Paricalcitol (Zemplar)
|
|---|---|
|
The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product
|
81 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 24 VisitPopulation: Analysis included all enrolled participants.
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.
Outcome measures
| Measure |
Chronic Kidney Disease
n=237 Participants
All eligible patients treated with IV Paricalcitol (Zemplar)
|
|---|---|
|
To Estimate the Incidence of (S)AEs/(S)ADRs
Experienced an adverse event (serious/non-serious)
|
196 participants
|
|
To Estimate the Incidence of (S)AEs/(S)ADRs
>Experienced non-serious adverse event
|
170 participants
|
|
To Estimate the Incidence of (S)AEs/(S)ADRs
>Experienced serious adverse event
|
94 participants
|
|
To Estimate the Incidence of (S)AEs/(S)ADRs
Experienced non-serious adverse drug reaction
|
127 participants
|
|
To Estimate the Incidence of (S)AEs/(S)ADRs
Experienced serious adverse drug reaction
|
10 participants
|
|
To Estimate the Incidence of (S)AEs/(S)ADRs
Total number of deaths reported
|
43 participants
|
|
To Estimate the Incidence of (S)AEs/(S)ADRs
>Number of deaths during the study
|
41 participants
|
|
To Estimate the Incidence of (S)AEs/(S)ADRs
>Number of deaths after study completion
|
2 participants
|
|
To Estimate the Incidence of (S)AEs/(S)ADRs
Death considered related to study drug
|
2 participants
|
Adverse Events
Chronic Kidney Disease
Serious events: 94 serious events
Other events: 170 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chronic Kidney Disease
n=237 participants at risk
All eligible patients treated with IV Paricalcitol (Zemplar)
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Cardiac arrest
|
5.1%
12/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
3.4%
8/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
3.0%
7/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Angina pectoris
|
2.1%
5/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Chest pain
|
2.1%
5/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
3/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Coronary artery disease
|
1.3%
3/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Arrhythmia
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Atrioventricular block
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Cardiogenic shock
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Cyanosis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Pericarditis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Sinus arrest
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Melaena
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Haematemesis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Ileus
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Palatal oedema
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
General disorders
Pyrexia
|
6.3%
15/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
General disorders
Chills
|
1.3%
3/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
General disorders
Death
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
General disorders
Medical device complication
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
General disorders
Asthenia
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
General disorders
Fatigue
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
General disorders
Malaise
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
General disorders
Pain
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
General disorders
Treatment failure
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Hepatobiliary disorders
Jaundice
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Hepatobiliary disorders
Cholangitis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Hepatobiliary disorders
Gallbladder oedema
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Respiratory tract infection
|
4.2%
10/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Septic shock
|
2.1%
5/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Pneumonia
|
1.3%
3/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Sepsis
|
1.3%
3/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Bacteraemia
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Gangrene
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Infection
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Abscess
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Bronchitis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Device related infection
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Infected skin ulcer
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Muscle abscess
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Postoperative wound infection
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Salmonellosis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Wound infection
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Injury, poisoning and procedural complications
Fistula
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Injury, poisoning and procedural complications
Vascular access infection
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Investigations
Blood calcium increased
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Investigations
Blood pressure decreased
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Investigations
Blood pressure increased
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Investigations
Haematocrit decreased
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Investigations
Hematocrit increased
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Investigations
Weight decreased
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
1.3%
3/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Musculoskeletal and connective tissue disorders
Femur fracture
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral discitis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Musculoskeletal and connective tissue disorders
Necrotising fasciitis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrinoma
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Nervous system disorders
Coma
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Nervous system disorders
Dizziness
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Nervous system disorders
Encephalitis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Nervous system disorders
Epilepsy
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Nervous system disorders
Headache
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Nervous system disorders
Intracranial haematoma
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Nervous system disorders
Syncope
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Psychiatric disorders
Agitation
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Psychiatric disorders
Communication disorder
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Psychiatric disorders
Confusional state
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Renal and urinary disorders
Renal cyst ruptured
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
9/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.7%
4/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.3%
3/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
1.3%
3/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Vascular disorders
Haemorrhage
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Vascular disorders
Hypotension
|
0.84%
2/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Vascular disorders
Femoral artery occlusion
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Vascular disorders
Hypertension
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Vascular disorders
Hypertensive crisis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Vascular disorders
Ischemia
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Vascular disorders
Poor venous access
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.42%
1/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
Other adverse events
| Measure |
Chronic Kidney Disease
n=237 participants at risk
All eligible patients treated with IV Paricalcitol (Zemplar)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
9/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Respiratory tract infection
|
2.5%
6/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Infections and infestations
Catheter site infection
|
1.3%
3/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Investigations
Calcium phosphate product increased
|
35.4%
84/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Investigations
Blood phosphorous increased
|
11.4%
27/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Investigations
Haematocrit decreased
|
5.9%
14/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Investigations
Blood parathyroid hormone decreased
|
3.8%
9/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Investigations
Blood calcium increased
|
3.4%
8/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Investigations
Haematocrit increased
|
2.5%
6/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Investigations
Serum ferritin decreased
|
2.1%
5/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Investigations
Blood pressure increased
|
1.3%
3/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
45.1%
107/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
8.0%
19/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.7%
4/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Psychiatric disorders
Anxiety disorder
|
2.1%
5/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
6/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
|
Vascular disorders
Hypertension
|
1.7%
4/237 • Adverse events were collected and reported from the time the participant signed the informed consent form until the end of the study. Participants were treated with Zemplar for an average of 19 months during the study.
|
Additional Information
Global Medical Services
Abbott
Phone: 1-800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER