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Trial to Optimize Mineral Outcomes in Dialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01100723
First received: April 7, 2010
Last updated: November 4, 2016
Last verified: November 2016
Results First Received: January 23, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Secondary Hyperparathyroidism
Chronic Kidney Disease
Intervention: Other: Cinacalcet, active vitamin D analogue

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No washout. Once enrolled, mineral and bone disorder managed by computer algorithm.

Reporting Groups
  Description
Post Treatment 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.

Participant Flow:   Overall Study
    Post Treatment
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Post Treatment Results analyzed at study evaluation time points.

Baseline Measures
   Post Treatment 
Overall Participants Analyzed 
[Units: Participants]
 92 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      60  65.2% 
>=65 years      32  34.8% 
Gender 
[Units: Participants]
Count of Participants
 
Female      40  43.5% 
Male      52  56.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent of Patients Achieving Parathyroid Hormone Target ≤ 300   [ Time Frame: 1 year ]

2.  Primary:   Percent of Patients Achieving Phosphorous Target ≤ 5.5   [ Time Frame: 1 year ]

3.  Secondary:   Percent of Patients Achieving Parathyroid Hormone Target ≤ 450   [ Time Frame: 1 year ]

4.  Secondary:   Percent of Patients Achieving Phosphorous Target ≤ 4.5   [ Time Frame: 1 year ]

5.  Secondary:   Percent of Patients Achieving Calcium Target ≤ 10.1   [ Time Frame: 1 year ]

6.  Secondary:   Percent of Patients on Cinacalcet and Vitamin D Analogues   [ Time Frame: 6 months and 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No adverse events reported. Dose titration limited by hypocalcemia and subject non-adherent to oral medications.


  More Information
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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:  
Name/Title: Dr. David M. Spiegel
Organization: University of Colorado
phone: 303-724-7797
e-mail: david.spiegel@ucdenver.edu


Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01100723     History of Changes
Other Study ID Numbers: 09-0623
Study First Received: April 7, 2010
Results First Received: January 23, 2013
Last Updated: November 4, 2016