Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00224042
First received: September 13, 2005
Last updated: February 29, 2012
Last verified: February 2012
Results First Received: December 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Anemia, Iron-Deficiency
Kidney Failure, Chronic
Interventions: Drug: Sodium Ferric Gluconate complex in sucrose
Drug: Ferrous sulfate tablets

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ferrlecit Sodium ferric gluconate complex in sucrose injection
Oral Iron No text entered.

Participant Flow:   Overall Study
    Ferrlecit     Oral Iron  
STARTED     26     26  
COMPLETED     20     20  
NOT COMPLETED     6     6  
Adverse Event                 2                 1  
Protocol Violation                 0                 1  
Physician Decision                 0                 1  
Did not meet lab incusion criteria                 2                 3  
Not specified                 2                 0  



  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.
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Reporting Groups
  Description
Ferrlecit Sodium ferric gluconate complex in sucrose injection
Oral Iron No text entered.
Total Total of all reporting groups

Baseline Measures
    Ferrlecit     Oral Iron     Total  
Number of Participants  
[units: participants]
  26     26     52  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     8     20  
>=65 years     14     18     32  
Age  
[units: years]
Mean ± Standard Deviation
  67.4  ± 17.75     66.1  ± 14.65     66.8  ± 16.13  
Gender  
[units: participants]
     
Female     12     16     28  
Male     14     10     24  
Region of Enrollment  
[units: participants]
     
United States     26     26     52  



  Outcome Measures
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1.  Primary:   Baseline Hemoglobin Concentration   [ Time Frame: Baseline ]

2.  Primary:   Change in Hemoglobin (Hgb)   [ Time Frame: Baseline to 10 weeks ]

3.  Secondary:   Baseline Serum Ferritin Concentration   [ Time Frame: Baseline ]

4.  Secondary:   Change in Serum Ferritin   [ Time Frame: Baseline to 10 weeks ]


  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
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  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: Gary Hoel, RPh, PhD, Executive Director of Clinical Research
Organization: Watson Laboratories, Inc.
phone: 801-588-6641
e-mail: gary.hoel@watson.com


No publications provided


Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00224042     History of Changes
Other Study ID Numbers: FER0201
Study First Received: September 13, 2005
Results First Received: December 23, 2009
Last Updated: February 29, 2012
Health Authority: United States: Food and Drug Administration