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A Double Blind Randomized Placebo Trial of Maintenance of Normal Serum Phosphorus in CKD

This study has been completed.
Sponsor:
Collaborators:
Shire
Fresenius Medical Care North America
Genzyme, a Sanofi Company
Novartis Pharmaceuticals
DaVita Dialysis
Information provided by (Responsible Party):
Denver Nephrologists, P.C.
ClinicalTrials.gov Identifier:
NCT00785629
First received: November 4, 2008
Last updated: September 28, 2012
Last verified: September 2012
Results First Received: August 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Chronic Kidney Disease
Interventions: Drug: Calcium acetate
Drug: Lanthanum Carbonate
Drug: Sevelamer Carbonate
Drug: Placebo

  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
Single center private practice single specialty clinic, Enrollment Feb 2009 thru September 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Consecutive CKD patients with eGFR 20- 45 ml/min with serum Phosphorus >3.5 < 6.0. Stratified by diabetic status. 3 subjects were enrolled but did not receive study medication due to withdrawal prior to starting medication.

Reporting Groups
  Description
Calcium Acetate phosphate binder : starting dose 667mg;titrations to 2668mg QAC
Sevelamer Carbonate phosphate binder : starting dose 800mg; titrations to 3200mg QAC
Lanthanum Carbonate phosphate binder : starting dose 500mg; titrations to 1500mg QAC
Placebo No text entered.

Participant Flow:   Overall Study
    Calcium Acetate     Sevelamer Carbonate     Lanthanum Carbonate     Placebo  
STARTED     30     30     28     57  
COMPLETED     22 [1]   25 [2]   18 [3]   41 [4]
NOT COMPLETED     8     5     10     16  
Adverse Event                 2                 1                 1                 5  
Protocol Violation                 1                 2                 4                 5  
administrative decision                 5                 1                 3                 4  
Withdrawal by Subject                 0                 1                 2                 2  
[1] 8 not completed
[2] 5 not completed
[3] 10 not completed
[4] 16 not completed



  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
Calcium Acetate phosphate binder : starting dose 667mg;titrations to 2668mg QAC
Sevelamer Carbonate phosphate binder : starting dose 800mg; titrations to 3200mg QAC
Lanthanum Carbonate phosphate binder : starting dose 500mg; titrations to 1500mg QAC
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Calcium Acetate     Sevelamer Carbonate     Lanthanum Carbonate     Placebo     Total  
Number of Participants  
[units: participants]
  30     30     28     57     145  
Age  
[units: years]
Mean ± Standard Deviation
  68  ± 12     66  ± 12     70  ± 10     65  ± 12     67  ± 12  
Gender  
[units: participants]
         
Female     14     15     13     29     71  
Male     16     15     15     28     74  
Region of Enrollment  
[units: participants]
         
United States     30     30     28     57     145  



  Outcome Measures

1.  Primary:   Serum Phosphorus   [ Time Frame: months 3-9 ]


  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
Single center study; Modest size of study; pilot study not powered to detect differences among subgroups of actively treated patients


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Geoffrey A. Block, MD
Organization: Denver Nephrologists, P.C.
phone: 303-364-4775
e-mail: gablock@denverneph.net


No publications provided


Responsible Party: Denver Nephrologists, P.C.
ClinicalTrials.gov Identifier: NCT00785629     History of Changes
Other Study ID Numbers: PNT001
Study First Received: November 4, 2008
Results First Received: August 27, 2012
Last Updated: September 28, 2012
Health Authority: United States: Food and Drug Administration