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Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT) (PACE)

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ClinicalTrials.gov Identifier: NCT00823303
Recruitment Status : Completed
First Posted : January 15, 2009
Results First Posted : August 5, 2014
Last Update Posted : August 7, 2014
Sponsor:
Collaborators:
Henry Ford Hospital
Feinberg School of Medicine, Northwestern University
NorthShore University HealthSystem
Abbott
Information provided by (Responsible Party):
Daniel W. Coyne, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Secondary Hyperparathyroidism
Chronic Kidney Disease
Interventions Drug: Paricalcitol
Drug: Calcitriol
Enrollment 110
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paricalcitol Calcitriol
Hide Arm/Group Description

titrated to achieve 40-60% PTH suppression

Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression

titrated to achieve 40-60% PTH suppression

Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression

Period Title: Overall Study
Started 54 56
Completed 45 45
Not Completed 9 11
Arm/Group Title Paricalcitol Calcitriol Total
Hide Arm/Group Description

titrated to achieve 40-60% PTH suppression

Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression

titrated to achieve 40-60% PTH suppression

Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression

Total of all reporting groups
Overall Number of Baseline Participants 54 56 110
Hide Baseline Analysis Population Description
Stage 3 and 4 CKD with SHPT, age >18, a stable dose of phosphate binder (if receiving a binder), estimated glomerular filtration rate (eGFR) of 15-59 mL/min using the abbreviated MDRD equation, PTH >120 pg/mL, albumin-corrected calcium >8.5 mg/dL and <10.0 mg/dL, phosphorus <4.6 mg/dL.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 56 participants 110 participants
66.6  (13.2) 64.7  (12.6) 65.6  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 56 participants 110 participants
Female
24
  44.4%
30
  53.6%
54
  49.1%
Male
30
  55.6%
26
  46.4%
56
  50.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 56 participants 110 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
33
  61.1%
41
  73.2%
74
  67.3%
White
18
  33.3%
14
  25.0%
32
  29.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   5.6%
1
   1.8%
4
   3.6%
1.Primary Outcome
Title Confirmed Hypercalcemia
Hide Description Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.
Time Frame 24 week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paricalcitol Calcitriol
Hide Arm/Group Description:

titrated to achieve 40-60% PTH suppression

Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression

titrated to achieve 40-60% PTH suppression

Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression

Overall Number of Participants Analyzed 53 54
Measure Type: Number
Unit of Measure: participants
3 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paricalcitol, Calcitriol
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments On the basis of prior published reports, we estimated a 5% rate of hypercalcemia with paricalcitol and a 30% rate with calcitriol. To have a 90% power to detect a difference at the P=0.05 confidence level, 42 patients per group were needed. Assuming a 30% dropout rate over the course of the study, we planned to randomize 110 patients.
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paricalcitol Calcitriol
Hide Arm/Group Description

titrated to achieve 40-60% PTH suppression

Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression

titrated to achieve 40-60% PTH suppression

Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression

All-Cause Mortality
Paricalcitol Calcitriol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Paricalcitol Calcitriol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/53 (0.00%)      1/54 (1.85%)    
Endocrine disorders     
Hypercalcemia  [1]  0/53 (0.00%)  0 1/54 (1.85%)  1
Indicates events were collected by systematic assessment
[1]
Hypercalcemia requiring or prolonging hospitalization
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Paricalcitol Calcitriol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/53 (28.30%)      12/54 (22.22%)    
Musculoskeletal and connective tissue disorders     
Musculoskeletal *  15/53 (28.30%)  15 12/54 (22.22%)  12
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel W. Coyne
Organization: Washington University School of Medicine
Phone: 3143627211
EMail: dcoyne@dom.wustl.edu
Layout table for additonal information
Responsible Party: Daniel W. Coyne, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00823303     History of Changes
Other Study ID Numbers: 22095
First Submitted: December 12, 2008
First Posted: January 15, 2009
Results First Submitted: June 5, 2014
Results First Posted: August 5, 2014
Last Update Posted: August 7, 2014