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A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients

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ClinicalTrials.gov Identifier: NCT01506947
Recruitment Status : Completed
First Posted : January 10, 2012
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Moderate to Severe Secondary Hyperparathyroidism
Stage 5 Chronic Kidney Diseases
Interventions Drug: Paricalcitol
Drug: Darbepoetin alfa
Enrollment 65
Recruitment Details This study was conducted at 7 centers in Turkey.
Pre-assignment Details  
Arm/Group Title Paricalcitol
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Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.

Period Title: Overall Study
Started 65
Completed 49
Not Completed 16
Reason Not Completed
Lost to Follow-up             7
Adverse Event             5
Death             1
Did Not Meet Eligibility Criteria             3
Arm/Group Title Paricalcitol
Hide Arm/Group Description

Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.

Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
The per-protocol analysis set which included participants who completed the study according to the protocol. One patient was enrolled into the study under protocol version 1.0 and was not included in the per-protocol analysis set due to subsequent major changes to the protocol.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants
49.6  (16.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
26
  54.2%
Male
22
  45.8%
1.Primary Outcome
Title Mean Erythropoietin Dose Per Visit
Hide Description The requirement of erythropoietin (EPO) treatment to maintain serum hemoglobin levels between 10 to 11.5 g/dL during the study was assessed by analysis of the dose of darbepoetin alfa used at baseline and during each month of the study. The mean EPO dosage per injection for each study month is reported.
Time Frame Baseline and Months 1, 2, 3, 4, 5 and 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set with EPO dosage available at all visits.
Arm/Group Title Paricalcitol
Hide Arm/Group Description:

Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.

Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: µg
Baseline 35.8  (15.0)
Month 1 22.2  (20.0)
Month 2 22.7  (21.3)
Month 3 4.7  (4.5)
Month 4 7.2  (6.2)
Month 5 17.3  (19.5)
Month 6 21.8  (19.7)
2.Secondary Outcome
Title Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire
Hide Description The Medical Outcome Study Short Form 36-Item Health Survey (SF-36) is a self-administered questionnaire that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains. The domains include physical (physical functioning, role limitations due to physical health (role-physical), general health perceptions and pain) and mental domains (energy/fatigue (vitality), social functioning, emotional well-being (mental health), and role limitations due to emotional problems (role emotional)). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set
Arm/Group Title Paricalcitol
Hide Arm/Group Description:

Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.

Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Function - Baseline 51.7  (26.3)
Physical Function - Month 6 51.5  (30.1)
Role Physical - Baseline 38.5  (45.2)
Role Physical - Month 6 44.3  (46.5)
Role Emotional - Baseline 52.8  (46.0)
Role Emotional - Month 6 54.2  (47.0)
Vitality - Baseline 47.4  (16.5)
Vitality - Month 6 45.2  (17.0)
Mental Health - Baseline 54.5  (12.6)
Mental Health - Month 6 52.7  (15.2)
Social Functioning - Baseline 59.6  (20.7)
Social Functioning - Month 6 55.5  (26.3)
Pain - Baseline 61.3  (26.6)
Pain - Month 6 60.5  (25.0)
General Health - Baseline 47.0  (16.9)
General Health - Month 6 44.4  (22.3)
3.Secondary Outcome
Title Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6
Hide Description [Not Specified]
Time Frame Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set with available data at each time point.
Arm/Group Title Paricalcitol
Hide Arm/Group Description:

Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.

Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline Number Analyzed 48 participants
918.0  (585.9)
Month 6 Number Analyzed 46 participants
692.5  (413.4)
4.Secondary Outcome
Title Mean Calcium Level at Baseline and Month 6
Hide Description [Not Specified]
Time Frame Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set with available data at each time point.
Arm/Group Title Paricalcitol
Hide Arm/Group Description:

Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.

Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: mg/mL
Baseline Number Analyzed 48 participants
8.81  (0.95)
Month 6 Number Analyzed 46 participants
9.29  (0.86)
5.Secondary Outcome
Title Mean Phosphorus Level at Baseline and Month 6
Hide Description [Not Specified]
Time Frame Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study with available data at each time point.
Arm/Group Title Paricalcitol
Hide Arm/Group Description:

Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.

Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: mg/mL
Baseline Number Analyzed 48 participants
4.87  (1.11)
Month 6 Number Analyzed 46 participants
5.47  (1.22)
6.Secondary Outcome
Title Mean Alkaline Phosphatase Level at Baseline and Month 6
Hide Description [Not Specified]
Time Frame Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set with available data at each time point.
Arm/Group Title Paricalcitol
Hide Arm/Group Description:

Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.

Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline Number Analyzed 48 participants
225.7  (170.1)
Month 6 Number Analyzed 46 participants
172.9  (147.6)
7.Secondary Outcome
Title Vitamin B12 Levels
Hide Description

Vitamin B12 levels were categorized according to the following laboratory reference ranges:

Low: < 200 pg/mL Normal: 200 – 950 pg/mL High: > 950 pg/mL

Time Frame Baseline and month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set with available data at each time point.
Arm/Group Title Baseline Month 6
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 48 46
Measure Type: Count of Participants
Unit of Measure: Participants
Low
2
   4.2%
0
   0.0%
Normal
13
  27.1%
22
  47.8%
High
33
  68.8%
24
  52.2%
8.Secondary Outcome
Title Folic Acid Levels
Hide Description

Folic acid levels were categorized according to the following laboratory reference ranges:

Low: < 4.6 ng/mL Normal: 4.6 – 18.7 ng/mL High: > 18.7 ng/mL

Time Frame Baseline and month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set with available data at each time point.
Arm/Group Title Baseline Month 6
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 48 46
Measure Type: Count of Participants
Unit of Measure: Participants
Low
1
   2.1%
4
   8.7%
Normal
25
  52.1%
25
  54.3%
High
22
  45.8%
17
  37.0%
9.Secondary Outcome
Title Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6
Hide Description [Not Specified]
Time Frame Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set with available data at each time point.
Arm/Group Title Paricalcitol
Hide Arm/Group Description:

Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.

Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: mg/mL
Baseline Number Analyzed 48 participants
11.8  (14.1)
Month 6 Number Analyzed 46 participants
14.4  (20.7)
10.Secondary Outcome
Title Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6
Hide Description [Not Specified]
Time Frame Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set with available data at each time point.
Arm/Group Title Paricalcitol
Hide Arm/Group Description:

Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.

Overall Number of Participants Analyzed 46
Mean (Standard Deviation)
Unit of Measure: kRU/L
Baseline Number Analyzed 46 participants
6267  (5967)
Month 6 Number Analyzed 44 participants
11340  (13450)
11.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description

Serious adverse events were any adverse events meeting any of the following criteria:

  • An event that resulted in the death of a participant;
  • An event that, in the opinion of the investigator, would have resulted in immediate fatality if medical intervention had not been taken (life-threatening);
  • Resulted in an admission to the hospital for any length of time or prolonged hospital stay;
  • An anomaly detected at or after birth, or any anomaly that results in fetal loss;
  • An event that resulted in a condition that substantially interfered with the activities of daily living;
  • An important medical event that may not be immediately life-threatening or result in death or hospitalization, but based on medical judgment may have jeopardized the participant and may have required medical or surgical intervention to prevent any of the outcomes listed above.

Adverse events were assessed by the investigator for possible relationship to study drug.

Time Frame From the time of study drug administration until 4 weeks after the discontinuation of the study drug; up to 7 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who enrolled.
Arm/Group Title Paricalcitol
Hide Arm/Group Description:

Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.

Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: participants
Non-serious adverse events 9
Serious adverse events 11
Treatment-related adverse events 0
Fatal adverse events 3
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paricalcitol
Hide Arm/Group Description

Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.

All-Cause Mortality
Paricalcitol
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paricalcitol
Affected / at Risk (%)
Total   11/65 (16.92%) 
Blood and lymphatic system disorders   
Haemoconcentration  1  1/65 (1.54%) 
Cardiac disorders   
Cardio-respiratory arrest  1  1/65 (1.54%) 
Acute coronary syndrome  1  1/65 (1.54%) 
Palpitations  1  2/65 (3.08%) 
Cardiac valve disease  1  1/65 (1.54%) 
Arrhythmia  1  1/65 (1.54%) 
Mitral valve incompetence  1  1/65 (1.54%) 
Gastrointestinal disorders   
Ascites  1  1/65 (1.54%) 
Abdominal pain upper  1  1/65 (1.54%) 
Stools watery  1  1/65 (1.54%) 
Faeces discoloured  1  1/65 (1.54%) 
Gastric ulcer  1  1/65 (1.54%) 
Upper gastrointestinal haemorrhage  1  1/65 (1.54%) 
General disorders   
Asthenia  1  2/65 (3.08%) 
Fatigue  1  1/65 (1.54%) 
Pyrexia  1  2/65 (3.08%) 
Chest Pain  1  1/65 (1.54%) 
Infections and infestations   
Soft tissue infection  1  1/65 (1.54%) 
Lung infection  1  1/65 (1.54%) 
Respiratory Tract Infection  1  1/65 (1.54%) 
Injury, poisoning and procedural complications   
Arteriovenous fistula site complication  1  1/65 (1.54%) 
Arteriovenous fistula thrombosis  1  2/65 (3.08%) 
Investigations   
Haemoglobin decreased  1  1/65 (1.54%) 
Haemoglobin increased  1  1/65 (1.54%) 
Metabolism and nutrition disorders   
Hyperkalaemia  1  1/65 (1.54%) 
Nervous system disorders   
Loss of consciousness  1  1/65 (1.54%) 
Somnolence  1  1/65 (1.54%) 
Cerebrovascular Accident  1  1/65 (1.54%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  1/65 (1.54%) 
Productive cough  1  1/65 (1.54%) 
Cough  1  1/65 (1.54%) 
Dyspnoea  1  4/65 (6.15%) 
Acute Respiratory distress syndrome  1  1/65 (1.54%) 
Respiratory arrest  1  1/65 (1.54%) 
Skin and subcutaneous tissue disorders   
Erythema  1  1/65 (1.54%) 
Diabetic foot  1  1/65 (1.54%) 
Surgical and medical procedures   
Nephrectomy  1  1/65 (1.54%) 
Parathyroidectomy  1  1/65 (1.54%) 
Renal transplant  1  2/65 (3.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Paricalcitol
Affected / at Risk (%)
Total   1/65 (1.54%) 
Ear and labyrinth disorders   
Vertigo  1  1/65 (1.54%) 
Gastrointestinal disorders   
Abdominal pain upper  1  1/65 (1.54%) 
Nausea  1  1/65 (1.54%) 
Gastric haemorrhage  1  1/65 (1.54%) 
General disorders   
Chest pain  1  1/65 (1.54%) 
Pain  1  1/65 (1.54%) 
Infections and infestations   
Nasopharyngitis  1  1/65 (1.54%) 
Injury, poisoning and procedural complications   
Arteriovenous fistula site haemorrhage  1  1/65 (1.54%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  1/65 (1.54%) 
Nervous system disorders   
Headache  1  1/65 (1.54%) 
Dizziness  1  1/65 (1.54%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  1/65 (1.54%) 
Dyspnoea  1  1/65 (1.54%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  1/65 (1.54%) 
Vascular disorders   
Arteriovenous fistula  1  1/65 (1.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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.
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.
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: NCT01506947     History of Changes
Other Study ID Numbers: W12-645
First Submitted: December 28, 2011
First Posted: January 10, 2012
Results First Submitted: April 6, 2017
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017