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Trial to Optimize Mineral Outcomes in Dialysis Patients

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ClinicalTrials.gov Identifier: NCT01100723
Recruitment Status : Completed
First Posted : April 9, 2010
Results First Posted : January 2, 2017
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Secondary Hyperparathyroidism
Chronic Kidney Disease
Intervention Other: Cinacalcet, active vitamin D analogue
Enrollment 92
Recruitment Details 181 pts in dialysis center. 65 did not meet enrollment criteria. 23 declined participation and 1 had prior intolerance to cinacalcet. Therefore 92 subjects enrolled in study.
Pre-assignment Details No washout. Once enrolled, mineral and bone disorder managed by computer algorithm.
Arm/Group Title Post Treatment
Hide Arm/Group Description Patients had their mineral and bone disorders managed by the computer directed algorithm. Cinacalcet dose was increased starting at 30 mg/day as indicated by protocol along with active vitamin D based on values of serum calcium, phosphorus and parathyroid hormone.
Period Title: Overall Study
Started 92
6 Month Analysis 85 [1]
Completed 78 [2]
Not Completed 14
[1]
85 subjects had laboratory data at the 6 month analysis and were compared to their baseline data.
[2]
78 subjects had laboratory data at the 12 month analysis and were compared to their baseline data.
Arm/Group Title Post Treatment
Hide Arm/Group Description Results analyzed at study evaluation time points.
Overall Number of Baseline Participants 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
<=18 years
0
   0.0%
Between 18 and 65 years
60
  65.2%
>=65 years
32
  34.8%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Female
40
  43.5%
Male
52
  56.5%
1.Primary Outcome
Title Percent of Patients Achieving Parathyroid Hormone Target ≤ 300
Hide Description Compare the percent of patients achieving an intact Parathyroid hormone (PTH) target of ≤ 300 pg/ml before and after the application of a computerized dosing protocol for management of chronic kidney disease-mineral and bone disorder (CKD-MBD). If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had at least one laboratory measurement during the assessment phase.
Arm/Group Title Post Treatment
Hide Arm/Group Description:
Results analyzed at study evaluation time points.
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: percentage of subjects meeting target
21
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Post Treatment
Comments Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
2.Primary Outcome
Title Percent of Patients Achieving Phosphorous Target ≤ 5.5
Hide Description Compare the percent of patients achieving a phosphorus of ≤ 5.5 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Results Analyzed at Study Evaluation Time Points.
Hide Arm/Group Description:
Results analyzed at study evaluation time points of 1 year and 6 months.
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: percent of participants in target
53
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Results Analyzed at Study Evaluation Time Points.
Comments Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
3.Secondary Outcome
Title Percent of Patients Achieving Parathyroid Hormone Target ≤ 450
Hide Description Compare the percent of patients achieving an intact PTH target of ≤ 450 pg/ml before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Post Treatment
Hide Arm/Group Description:
Results analyzed at study evaluation time points.
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: percent of participants in target
33
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Post Treatment
Comments Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
4.Secondary Outcome
Title Percent of Patients Achieving Phosphorous Target ≤ 4.5
Hide Description Compare the percent of patients achieving a phosphorus of ≤ 4.5 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Post Treatment
Hide Arm/Group Description:
Results analyzed at study evaluation time points.
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: percent of participants in target
29
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Post Treatment
Comments Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
5.Secondary Outcome
Title Percent of Patients Achieving Calcium Target ≤ 10.1
Hide Description Compare the percent of patients achieving a calcium ≤ 10.1 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with at least one laboratory value during evaluation period.
Arm/Group Title Post Treatment
Hide Arm/Group Description:
Results analyzed at study evaluation time points.
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: percentage of subjects in target
78
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Post Treatment
Comments Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with Ca values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
6.Secondary Outcome
Title Percent of Patients on Cinacalcet and Vitamin D Analogues
Hide Description Compare the percent of patients on cinacalcet and vitamin D analogues at baseline and at 6 and 12 months after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.
Time Frame 6 months and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with at least 1 laboratory analysis during the evaluation period.
Arm/Group Title Post Treatment
Hide Arm/Group Description:
Results analyzed at study evaluation time points.
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: percentage of subjects receiving med
84
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Post Treatment
Comments Proportion of subjects on specified medications were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects on the specified medications was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Post Treatment
Hide Arm/Group Description Results analyzed at study evaluation time points.
All-Cause Mortality
Post Treatment
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Post Treatment
Affected / at Risk (%)
Total   0/92 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Post Treatment
Affected / at Risk (%)
Total   0/92 (0.00%) 
No adverse events reported. Dose titration limited by hypocalcemia and subject non-adherent to oral medications.
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. David M. Spiegel
Organization: University of Colorado
Phone: 303-724-7797
EMail: david.spiegel@ucdenver.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01100723    
Other Study ID Numbers: 09-0623
First Submitted: April 7, 2010
First Posted: April 9, 2010
Results First Submitted: January 23, 2013
Results First Posted: January 2, 2017
Last Update Posted: January 2, 2017