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Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands

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ClinicalTrials.gov Identifier: NCT01273597
Recruitment Status : Completed
First Posted : January 10, 2011
Results First Posted : December 21, 2012
Last Update Posted : January 18, 2013
Sponsor:
Collaborator:
Planimeter Ltd
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Kidney Failure, Chronic
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title End-stage Kidney Disease With Secondary Hyperparathyroidism
Hide Arm/Group Description Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Period Title: Overall Study
Started 60
Completed 52
Not Completed 8
Reason Not Completed
Adverse Event             5
Underwent Kidney Transplantation             2
Reason Not Reported             1
Arm/Group Title End-stage Kidney Disease With Secondary Hyperparathyroidism
Hide Arm/Group Description Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants
57.7
(31 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
31
  51.7%
Male
29
  48.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Hungary Number Analyzed 60 participants
60
1.Primary Outcome
Title Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)
Hide Description Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved maintenance dose of Zemplar (paricalcitol injection)
Arm/Group Title End-stage Kidney Disease With Secondary Hyperparathyroidism
Hide Arm/Group Description:
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: weeks
12.2  (7.6)
2.Secondary Outcome
Title Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6
Hide Description Target intact parathyroid hormone (iPTH) values were within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title End-stage Kidney Disease With Secondary Hyperparathyroidism
Hide Arm/Group Description:
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
14
3.Secondary Outcome
Title Country–Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance
Hide Description If available, data on vitamin D treatment (those who received vitamin D supplement products from Anatomical Therapeutic Chemical [ATC] group A11CC [vitamin D and analogues]) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
Time Frame 6 months prior to start of study through 6 months of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed due to lack of data.
Arm/Group Title End-stage Kidney Disease With Secondary Hyperparathyroidism
Hide Arm/Group Description:
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Country–Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance
Hide Description If available, data on the use of phosphate binders (those who received calcium-based phosphate binders or sevelamer/lanthanum) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
Time Frame 6 months prior to start of study through 6 months of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed due to lack of data.
Arm/Group Title End-stage Kidney Disease With Secondary Hyperparathyroidism
Hide Arm/Group Description:
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Country–Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism
Hide Description If available, data on the use of medication affecting secondary hyperparathyroidism (those who received calcimimetics and calcium supplementation) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
Time Frame 6 months prior to start of study through 6 months of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed due to lack of data.
Arm/Group Title End-stage Kidney Disease With Secondary Hyperparathyroidism
Hide Arm/Group Description:
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy
Hide Description Hypercalcaemia (serum calcium > 2.6 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).
Time Frame 6 months prior to start of study through baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available retrospective data
Arm/Group Title End-stage Kidney Disease With Secondary Hyperparathyroidism
Hide Arm/Group Description:
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: participants
5
7.Secondary Outcome
Title Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
Hide Description Hypercalcaemia (serum calcium > 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available retrospective data (cohort analyzed for Outcome Measure 6) were analyzed prospectively at Month 6 of treatment.
Arm/Group Title End-stage Kidney Disease With Secondary Hyperparathyroidism
Hide Arm/Group Description:
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: participants
20
8.Secondary Outcome
Title Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy
Hide Description Hyperphosphataemia (serum phosphorus >1.78 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).
Time Frame 6 months prior to start of study through baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available retrospective data
Arm/Group Title End-stage Kidney Disease With Secondary Hyperparathyroidism
Hide Arm/Group Description:
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: participants
39
9.Secondary Outcome
Title Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
Hide Description Hyperphosphataemia (serum phosphorus > 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available retrospective data (cohort analyzed for Outcome Measure 8) were analyzed prospectively at Month 6 of treatment.
Arm/Group Title End-stage Kidney Disease With Secondary Hyperparathyroidism
Hide Arm/Group Description:
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: participants
50
Time Frame Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title End-stage Kidney Disease With Secondary Hyperparathyroidism
Hide Arm/Group Description Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
All-Cause Mortality
End-stage Kidney Disease With Secondary Hyperparathyroidism
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
End-stage Kidney Disease With Secondary Hyperparathyroidism
Affected / at Risk (%)
Total   9/60 (15.00%) 
Blood and lymphatic system disorders   
Anaemia  1  1/60 (1.67%) 
Cardiac disorders   
Atrial fibrillation  1  1/60 (1.67%) 
Gastrointestinal disorders   
Duodenal ulcer haemorrhage  1  1/60 (1.67%) 
Gastric ulcer haemorrhage  1  1/60 (1.67%) 
General disorders   
Inflammation  1  1/60 (1.67%) 
Pyrexia  1  1/60 (1.67%) 
Spinal pain  1  1/60 (1.67%) 
Bronchitis  1  1/60 (1.67%) 
Infections and infestations   
Abscess limb  1  1/60 (1.67%) 
Arthritis bacterial  1  1/60 (1.67%) 
Erysipelas  1  1/60 (1.67%) 
Gangrene  1  1/60 (1.67%) 
Pneumonia  1  2/60 (3.33%) 
Sepsis  1  2/60 (3.33%) 
Staphylococcal bacteraemia  1  1/60 (1.67%) 
Staphylococcal sepsis  1  1/60 (1.67%) 
Injury, poisoning and procedural complications   
Arteriovenous fistula site complication  1  1/60 (1.67%) 
Musculoskeletal and connective tissue disorders   
Sacroiliitis  1  1/60 (1.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma  1  2/60 (3.33%) 
Nervous system disorders   
Cerebrovascular accident  1  1/60 (1.67%) 
Ischaemic stroke  1  1/60 (1.67%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia  1  1/60 (1.67%) 
Pulmonary embolism  1  1/60 (1.67%) 
Respiratory failure  1  1/60 (1.67%) 
Skin and subcutaneous tissue disorders   
Skin lesion  1  1/60 (1.67%) 
Vascular disorders   
Arterial occlusive disease  1  1/60 (1.67%) 
Circulatory collapse  1  1/60 (1.67%) 
Hypertension  1  1/60 (1.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
End-stage Kidney Disease With Secondary Hyperparathyroidism
Affected / at Risk (%)
Total   16/60 (26.67%) 
Investigations   
Calcium phosphate product increased * 1  5/60 (8.33%) 
Metabolism and nutrition disorders   
Hypercalcaemia * 1  7/60 (11.67%) 
Hyperphoshataemia * 1  4/60 (6.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01273597     History of Changes
Other Study ID Numbers: P12-644
First Submitted: November 22, 2010
First Posted: January 10, 2011
Results First Submitted: November 21, 2012
Results First Posted: December 21, 2012
Last Update Posted: January 18, 2013