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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00224042
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : March 29, 2012
Last Update Posted : March 29, 2012
Information provided by (Responsible Party):
Watson Pharmaceuticals

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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

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
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Reporting Groups
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 
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 26   26   52 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   12   8   20 
>=65 years   14   18   32 
[Units: Years]
Mean (Standard Deviation)
 67.4  (17.75)   66.1  (14.65)   66.8  (16.13) 
[Units: Participants]
Female   12   16   28 
Male   14   10   24 
Region of Enrollment 
[Units: Participants]
United States   26   26   52 

  Outcome Measures

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

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

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

Responsible Party: Watson Pharmaceuticals Identifier: NCT00224042     History of Changes
Other Study ID Numbers: FER0201
First Submitted: September 13, 2005
First Posted: September 22, 2005
Results First Submitted: December 23, 2009
Results First Posted: March 29, 2012
Last Update Posted: March 29, 2012