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Trial record 23 of 46 for:    FERRIC SULFATE

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

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ClinicalTrials.gov Identifier: NCT00224042
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : March 29, 2012
Last Update Posted : March 29, 2012
Sponsor:
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
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ferrlecit Oral Iron
Hide Arm/Group Description Sodium ferric gluconate complex in sucrose injection [Not Specified]
Period Title: Overall Study
Started 26 26
Completed 20 20
Not Completed 6 6
Reason Not Completed
Adverse Event             2             1
Protocol Violation             0             1
Physician Decision             0             1
Did not meet lab incusion criteria             2             3
Not specified             2             0
Arm/Group Title Ferrlecit Oral Iron Total
Hide Arm/Group Description Sodium ferric gluconate complex in sucrose injection [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 26 26 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  46.2%
8
  30.8%
20
  38.5%
>=65 years
14
  53.8%
18
  69.2%
32
  61.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 26 participants 52 participants
67.4  (17.75) 66.1  (14.65) 66.8  (16.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Female
12
  46.2%
16
  61.5%
28
  53.8%
Male
14
  53.8%
10
  38.5%
24
  46.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 26 participants 52 participants
26 26 52
1.Primary Outcome
Title Baseline Hemoglobin Concentration
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferrlecit Oral Iron
Hide Arm/Group Description:
Sodium ferric gluconate complex in sucrose injection
[Not Specified]
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: g/dL
10.3  (0.90) 10.4  (0.92)
2.Primary Outcome
Title Change in Hemoglobin (Hgb)
Hide Description Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Time Frame Baseline to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT with LOCF imputation
Arm/Group Title Ferrlecit Oral Iron
Hide Arm/Group Description:
Sodium ferric gluconate complex in sucrose injection
[Not Specified]
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: g/dL
1.2  (1.23) 1.0  (1.34)
3.Secondary Outcome
Title Baseline Serum Ferritin Concentration
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferrlecit Oral Iron
Hide Arm/Group Description:
Sodium ferric gluconate complex in sucrose injection
[Not Specified]
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
74.3  (80.95) 68.7  (67.36)
4.Secondary Outcome
Title Change in Serum Ferritin
Hide Description Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Time Frame Baseline to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT with LOCF imputation
Arm/Group Title Ferrlecit Oral Iron
Hide Arm/Group Description:
Sodium ferric gluconate complex in sucrose injection
[Not Specified]
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
150.0  (113.11) 18.1  (33.66)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ferrlecit Oral Iron
Hide Arm/Group Description Sodium ferric gluconate complex in sucrose injection [Not Specified]
All-Cause Mortality
Ferrlecit Oral Iron
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ferrlecit Oral Iron
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/26 (15.38%)      2/26 (7.69%)    
Cardiac disorders     
Acerbation of Chronic Heart Failure * 1  1/26 (3.85%)  1 1/26 (3.85%)  1
Acute Coronary Syndrome * 1  0/26 (0.00%)  0 1/26 (3.85%)  1
Myocardiac Infarction * 1  0/26 (0.00%)  0 1/26 (3.85%)  1
General disorders     
Pain Chest * 1  1/26 (3.85%)  1 0/26 (0.00%)  0
Metabolism and nutrition disorders     
Gout Attack * 1  1/26 (3.85%)  1 0/26 (0.00%)  0
Renal and urinary disorders     
Pyelonephritis * 1  1/26 (3.85%)  1 0/26 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary Edema * 1  0/26 (0.00%)  0 1/26 (3.85%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, COSTART
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ferrlecit Oral Iron
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/26 (69.23%)      16/26 (61.54%)    
Blood and lymphatic system disorders     
Anemia * 1  0/26 (0.00%)  0 2/26 (7.69%)  2
Gastrointestinal disorders     
Diarrhea * 1  5/26 (19.23%)  7 3/26 (11.54%)  3
Gastritis * 1  2/26 (7.69%)  2 1/26 (3.85%)  1
Nausea * 1  4/26 (15.38%)  6 1/26 (3.85%)  1
Vomiting * 1  2/26 (7.69%)  5 0/26 (0.00%)  0
Constipation * 1  1/26 (3.85%)  1 2/26 (7.69%)  2
Melena * 1  0/26 (0.00%)  0 2/26 (7.69%)  2
General disorders     
Fever * 1  2/26 (7.69%)  2 1/26 (3.85%)  1
Abdominal Pain * 1  2/26 (7.69%)  3 0/26 (0.00%)  0
Infections and infestations     
Infection * 1  4/26 (15.38%)  4 0/26 (0.00%)  0
Injury, poisoning and procedural complications     
Accidental Injury * 1  2/26 (7.69%)  3 0/26 (0.00%)  0
Metabolism and nutrition disorders     
Edema * 1  0/26 (0.00%)  0 2/26 (7.69%)  2
Peripheral Edema * 1  0/26 (0.00%)  0 2/26 (7.69%)  2
Nervous system disorders     
Dizziness * 1  3/26 (11.54%)  3 1/26 (3.85%)  1
Respiratory, thoracic and mediastinal disorders     
Rhinitis * 1  2/26 (7.69%)  2 1/26 (3.85%)  2
Increase Cough * 1  1/26 (3.85%)  1 2/26 (7.69%)  2
Dyspnea * 1  0/26 (0.00%)  0 2/26 (7.69%)  2
Vascular disorders     
Hypertension * 1  3/26 (11.54%)  3 0/26 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, COSTART
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.
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
ClinicalTrials.gov 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