Trial Outcomes & Findings for Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT) (NCT NCT01224782)
NCT ID: NCT01224782
Last Updated: 2014-09-15
Results Overview
Mean time to achieve a \> 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).
Recruitment status
COMPLETED
Target enrollment
994 participants
Primary outcome timeframe
From Baseline up to 12 Months
Results posted on
2014-09-15
Participant Flow
Participant milestones
| Measure |
Chronic Kidney Disease, Secondary Hyperparathyroidism
All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
|
|---|---|
|
Overall Study
STARTED
|
994
|
|
Overall Study
COMPLETED
|
730
|
|
Overall Study
NOT COMPLETED
|
264
|
Reasons for withdrawal
| Measure |
Chronic Kidney Disease, Secondary Hyperparathyroidism
All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
|
|---|---|
|
Overall Study
Lost to Follow-up
|
177
|
|
Overall Study
Withdrawal by Subject
|
16
|
|
Overall Study
Death
|
14
|
|
Overall Study
Improvement
|
13
|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Adverse Reaction
|
11
|
|
Overall Study
Noncompliance
|
10
|
|
Overall Study
Other
|
4
|
|
Overall Study
Start of Dialysis
|
3
|
|
Overall Study
Change of Treatment
|
1
|
|
Overall Study
Financial Reasons
|
1
|
|
Overall Study
Deterioration
|
1
|
|
Overall Study
Transplantation
|
1
|
Baseline Characteristics
Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)
Baseline characteristics by cohort
| Measure |
Chronic Kidney Disease, Secondary Hyperparathyroidism
n=994 Participants
All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
|
|---|---|
|
Age, Continuous
|
64.29 years
STANDARD_DEVIATION 13.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
477 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
517 Participants
n=5 Participants
|
|
Baseline Chronic Kidney Disease Stage
Chronic Kidney Disease Stage 3
|
40.8 percentage of participants
n=5 Participants
|
|
Baseline Chronic Kidney Disease Stage
Chronic Kidney Disease Stage 4
|
59.2 percentage of participants
n=5 Participants
|
|
Baseline Intact Parathyroid Hormone (iPTH)
|
36.33 pmol/L
STANDARD_DEVIATION 53.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to 12 MonthsPopulation: The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study, with a \> 30% decrease in iPTH compared with the initial values at baseline.
Mean time to achieve a \> 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperparathyroidism
n=694 Participants
All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
|
|---|---|
|
Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values
|
3.82 months
Standard Deviation 3.37
|
PRIMARY outcome
Timeframe: From Baseline up to 12 MonthsPopulation: The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study.
The percentage of participants with Calcium x Phosphorus Product (CxP) values \> 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2 at any timepoint during followup, up to 12 months.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperparathyroidism
n=919 Participants
All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
|
|---|---|
|
Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2
|
7.4 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline up to 12 MonthsPopulation: Secondary analyses were conducted in the intent-to-treat (ITT) population, which included all participants who received at least 1 dose of study drug and with available data.
The percentage of participants with a decrease in iPTH levels \> 30% at any timepoint during followup, up to 12 months.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperparathyroidism
n=935 Participants
All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
|
|---|---|
|
Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)
|
75.3 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline up to 12 monthsPopulation: The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
The percentage of participants with hypercalcemia (Calcium \> 2.6 mmol/L \[10.5 mg/dL\]) at any timepoint during followup, up to 12 months.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperparathyroidism
n=994 Participants
All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
|
|---|---|
|
Percentage of Participants With Hypercalcemia
|
0.9 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline up to 12 monthsPopulation: Secondary analyses were conducted in the intent-to-treat (ITT) population, which included all participants who received at least 1 dose of study drug and with available data.
Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperparathyroidism
n=994 Participants
All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
|
|---|---|
|
Mean Weekly Dose of Zemplar (Paricalcitol)
Screening to Month 1 (N=994)
|
6.29 micrograms
Standard Deviation 2.49
|
|
Mean Weekly Dose of Zemplar (Paricalcitol)
Month 9 to Month 12 (N=737)
|
5.77 micrograms
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: Adverse events were collected from the screening visit to month 12 (total 13 months); Serious Adverse Events were collected from the time that informed consent was obtained to 30 days after last dose of study drug (up to 13 months)Population: The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug .
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to Zemplar (paricalcitol) were assessed as being either probably or possibly related by the investigator.
Outcome measures
| Measure |
Chronic Kidney Disease, Secondary Hyperparathyroidism
n=994 Participants
All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
Any AE
|
141 participants
|
|
Number of Participants With Adverse Events (AEs)
Any Serious AE
|
27 participants
|
|
Number of Participants With Adverse Events (AEs)
Deaths
|
14 participants
|
|
Number of Participants With Adverse Events (AEs)
Adverse Events Probably Related
|
14 participants
|
|
Number of Participants With Adverse Events (AEs)
AEs Possibly Related to Study Drug
|
14 participants
|
|
Number of Participants With Adverse Events (AEs)
AEs Probably Not Related to Study Drug
|
13 participants
|
|
Number of Participants With Adverse Events (AEs)
AEs Not Related to Study Drug
|
100 participants
|
Adverse Events
Chronic Kidney Disease, Secondary Hyperparathyroidism
Serious events: 27 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chronic Kidney Disease, Secondary Hyperparathyroidism
n=994 participants at risk
All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.30%
3/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.40%
4/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Cardiac disorders
Cardiac failure acute
|
0.20%
2/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Cardiac disorders
Chest pain
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.20%
2/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.30%
3/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
General disorders
Asthenia
|
0.20%
2/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
General disorders
Chest pain
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
General disorders
Malaise
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
General disorders
Pallor
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Hepatobiliary disorders
Liver disorder
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Immune system disorders
Cardiac amyloidosis
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Immune system disorders
Renal amyloidosis
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Metabolism and nutrition disorders
Oedema
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
2/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Psychiatric disorders
Psychiatric symptom
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Renal and urinary disorders
Congenital cystic kidney disease
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.40%
4/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.20%
2/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.40%
4/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.20%
2/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Surgical and medical procedures
Haemodialysis
|
0.40%
4/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Surgical and medical procedures
Leg amputation
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Surgical and medical procedures
Renal transplant
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Vascular disorders
Acute myocardial infarction
|
0.30%
3/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Vascular disorders
Atherosclerosis obliterans
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Vascular disorders
Diabetic foot
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Vascular disorders
Hypertensive nephropathy
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Vascular disorders
Ischaemia
|
0.10%
1/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Vascular disorders
Myocardial infarction
|
0.20%
2/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Vascular disorders
Pulmonary embolism
|
0.20%
2/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
Other adverse events
| Measure |
Chronic Kidney Disease, Secondary Hyperparathyroidism
n=994 participants at risk
All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
0.80%
8/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
General disorders
Asthenia
|
0.50%
5/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
General disorders
Pyrexia
|
0.80%
8/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.91%
9/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.60%
6/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Renal and urinary disorders
Azotaemia
|
0.50%
5/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.50%
5/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Renal and urinary disorders
Renal failure chronic
|
1.9%
19/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.50%
5/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Surgical and medical procedures
Haemodialysis
|
1.2%
12/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
|
Vascular disorders
Hypertension
|
1.3%
13/994 • All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER