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Trial record 35 of 47 for:    FERRIC SULFATE

2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.

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ClinicalTrials.gov Identifier: NCT00223977
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : September 28, 2009
Last Update Posted : July 8, 2013
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
Condition Iron Deficiency Anemia
Interventions Drug: Sodium Ferric Gluconate Complex
Drug: Oral Iron
Enrollment 146
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sodium Ferric Gluconate Complex 125 mg Sodium Ferric Gluconate Complex 250 mg Oral Iron
Hide Arm/Group Description 125 mg sodium ferric gluconate weekly x 8 weeks 250 mg sodium ferric gluconate complex weekly x 4 weeks 325 mg ferrous sulfate three times daily x 8 weeks
Period Title: Overall Study
Started 46 58 42
Completed 37 47 39
Not Completed 9 11 3
Reason Not Completed
Adverse Event             7             10             0
Protocol Violation             0             0             1
Withdrawal by Subject             1             1             2
not specified             1             0             0
Arm/Group Title Sodium Ferric Gluconate Complex 125 mg Sodium Ferric Gluconate Complex 250 mg Oral Iron Total
Hide Arm/Group Description 125 mg sodium ferric gluconate weekly x 8 weeks 250 mg sodium ferric gluconate complex weekly x 4 weeks 325 mg ferrous sulfate three times daily x 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 46 58 42 146
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 58 participants 42 participants 146 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
  73.9%
53
  91.4%
35
  83.3%
122
  83.6%
>=65 years
12
  26.1%
5
   8.6%
7
  16.7%
24
  16.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 58 participants 42 participants 146 participants
52.5  (14.11) 48.1  (12.49) 51.5  (12.88) 50.5  (13.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 58 participants 42 participants 146 participants
Female
23
  50.0%
30
  51.7%
27
  64.3%
80
  54.8%
Male
23
  50.0%
28
  48.3%
15
  35.7%
66
  45.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 58 participants 42 participants 146 participants
United States 3 4 3 10
Mexico 6 8 9 23
Poland 8 9 7 24
Croatia 4 8 4 16
Bulgaria 1 3 1 5
Russian Federation 19 19 14 52
India 5 7 4 16
1.Primary Outcome
Title Hemoglobin
Hide Description Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Time Frame Baseline to 5 weeks and 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent to treat (mITT) with last observation carried forward (LOCF) imputation
Arm/Group Title Sodium Ferric Gluconate Complex 125 mg Sodium Ferric Gluconate Complex 250 mg Oral Iron
Hide Arm/Group Description:
125 mg sodium ferric gluconate weekly x 8 weeks
250 mg sodium ferric gluconate complex weekly x 4 weeks
325 mg ferrous sulfate three times daily x 8 weeks
Overall Number of Participants Analyzed 46 55 42
Mean (Standard Deviation)
Unit of Measure: ng/mL
1.49  (1.09) 0.89  (1.35) 1.02  (1.55)
2.Secondary Outcome
Title Change From Baseline in Hematocrit (Hct)
Hide Description Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Time Frame Baseline to 5 weeks and 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Ferric Gluconate Complex 125 mg Sodium Ferric Gluconate Complex 250 mg Oral Iron
Hide Arm/Group Description:
125 mg sodium ferric gluconate weekly x 8 weeks
250 mg sodium ferric gluconate complex weekly x 4 weeks
325 mg ferrous sulfate three times daily x 8 weeks
Overall Number of Participants Analyzed 46 55 42
Mean (Standard Deviation)
Unit of Measure: percent
4.62  (3.37) 2.93  (4.61) 3.07  (4.59)
3.Secondary Outcome
Title Change From Baseline in Transferrin Saturation (TSAT).
Hide Description Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Time Frame Baseline to 5 weeks and 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Ferric Gluconate Complex 125 mg Sodium Ferric Gluconate Complex 250 mg Oral Iron
Hide Arm/Group Description:
125 mg sodium ferric gluconate weekly x 8 weeks
250 mg sodium ferric gluconate complex weekly x 4 weeks
325 mg ferrous sulfate three times daily x 8 weeks
Overall Number of Participants Analyzed 46 55 42
Mean (Standard Deviation)
Unit of Measure: percent
8.13  (8.77) 8.2  (9.31) 1.84  (6.5)
4.Secondary Outcome
Title Change From Baseline in Serum Ferritin.
Hide Description Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Time Frame Baseline to 5 weeks and 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Ferric Gluconate Complex 125 mg Sodium Ferric Gluconate Complex 250 mg Oral Iron
Hide Arm/Group Description:
125 mg sodium ferric gluconate weekly x 8 weeks
250 mg sodium ferric gluconate complex weekly x 4 weeks
325 mg ferrous sulfate three times daily x 8 weeks
Overall Number of Participants Analyzed 46 55 42
Mean (Standard Deviation)
Unit of Measure: ng/mL
259.88  (212.73) 368.67  (270.05) 26.98  (86.57)
5.Secondary Outcome
Title Responders by Treatment Group
Hide Description Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron.
Time Frame Baseline to 5 weeks and 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Ferric Gluconate Complex 125 mg Sodium Ferric Gluconate Complex 250 mg Oral Iron
Hide Arm/Group Description:
125 mg sodium ferric gluconate weekly x 8 weeks
250 mg sodium ferric gluconate complex weekly x 4 weeks
325 mg ferrous sulfate three times daily x 8 weeks
Overall Number of Participants Analyzed 46 55 42
Measure Type: Number
Unit of Measure: participants
30 22 20
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sodium Ferric Gluconate Complex 125 mg Sodium Ferric Gluconate Complex 250 mg Oral Iron
Hide Arm/Group Description 125 mg sodium ferric gluconate weekly x 8 weeks 250 mg sodium ferric gluconate complex weekly x 4 weeks 325 mg ferrous sulfate three times daily x 8 weeks
All-Cause Mortality
Sodium Ferric Gluconate Complex 125 mg Sodium Ferric Gluconate Complex 250 mg Oral Iron
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sodium Ferric Gluconate Complex 125 mg Sodium Ferric Gluconate Complex 250 mg Oral Iron
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/46 (6.52%)      13/58 (22.41%)      7/42 (16.67%)    
Blood and lymphatic system disorders       
ANEMIA  0/46 (0.00%)  0 0/58 (0.00%)  0 2/42 (4.76%)  2
PANCYTOPENIA  0/46 (0.00%)  0 0/58 (0.00%)  0 1/42 (2.38%)  1
Cardiac disorders       
FIBRILLAT ATR  0/46 (0.00%)  0 0/58 (0.00%)  0 1/42 (2.38%)  1
HYPERTENS  0/46 (0.00%)  0 0/58 (0.00%)  0 1/42 (2.38%)  2
HYPOTENS  0/46 (0.00%)  0 5/58 (8.62%)  5 0/42 (0.00%)  0
INFARCT MYOCARD  0/46 (0.00%)  0 1/58 (1.72%)  1 2/42 (4.76%)  2
PERICARDITIS  0/46 (0.00%)  0 1/58 (1.72%)  1 0/42 (0.00%)  0
SYNCOPE  0/46 (0.00%)  0 1/58 (1.72%)  1 0/42 (0.00%)  0
Gastrointestinal disorders       
DIARRHEA  0/46 (0.00%)  0 1/58 (1.72%)  1 0/42 (0.00%)  0
HEM RECTAL  1/46 (2.17%)  1 0/58 (0.00%)  0 0/42 (0.00%)  0
ULCER STOMACH  0/46 (0.00%)  0 1/58 (1.72%)  1 0/42 (0.00%)  0
VOMIT  0/46 (0.00%)  0 1/58 (1.72%)  1 0/42 (0.00%)  0
General disorders       
FEVER  0/46 (0.00%)  0 0/58 (0.00%)  0 1/42 (2.38%)  1
PERITONITIS  2/46 (4.35%)  2 5/58 (8.62%)  5 0/42 (0.00%)  0
Metabolism and nutrition disorders       
HYPERGLYCEM  0/46 (0.00%)  0 0/58 (0.00%)  0 1/42 (2.38%)  1
HYPERVOLEM  0/46 (0.00%)  0 0/58 (0.00%)  0 1/42 (2.38%)  1
KETOSIS  0/46 (0.00%)  0 0/58 (0.00%)  0 1/42 (2.38%)  1
Reproductive system and breast disorders       
METRORRHAGIA  0/46 (0.00%)  0 1/58 (1.72%)  1 0/42 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
EDEMA LUNG  0/46 (0.00%)  0 0/58 (0.00%)  0 1/42 (2.38%)  1
PNEUMONIA  0/46 (0.00%)  0 1/58 (1.72%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders       
CELLULITIS  0/46 (0.00%)  0 0/58 (0.00%)  0 1/42 (2.38%)  1
Surgical and medical procedures       
INJECT SITE REACT  0/46 (0.00%)  0 0/58 (0.00%)  0 1/42 (2.38%)  1
Vascular disorders       
CEREBROVASC ACCID  0/46 (0.00%)  0 1/58 (1.72%)  1 0/42 (0.00%)  0
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%
Sodium Ferric Gluconate Complex 125 mg Sodium Ferric Gluconate Complex 250 mg Oral Iron
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/46 (34.78%)      20/58 (34.48%)      12/42 (28.57%)    
Blood and lymphatic system disorders       
LAB TEST ABNORM  9/46 (19.57%)  11 8/58 (13.79%)  8 2/42 (4.76%)  2
Cardiac disorders       
HYPERTENS  4/46 (8.70%)  4 6/58 (10.34%)  6 4/42 (9.52%)  4
HYPOTENS  1/46 (2.17%)  2 4/58 (6.90%)  6 0/42 (0.00%)  0
Gastrointestinal disorders       
DIARRHEA  3/46 (6.52%)  3 3/58 (5.17%)  3 3/42 (7.14%)  4
PAIN ABDO  1/46 (2.17%)  1 1/58 (1.72%)  1 4/42 (9.52%)  4
NAUSEA  0/46 (0.00%)  0 3/58 (5.17%)  3 0/42 (0.00%)  0
General disorders       
INFECT  2/46 (4.35%)  2 1/58 (1.72%)  1 3/42 (7.14%)  3
PAIN  0/46 (0.00%)  0 3/58 (5.17%)  4 1/42 (2.38%)  1
1
Term from vocabulary, COSTART
Primary endpoint for the 250 mg dose was 4 weeks earlier than the endpoint for the 125 mg dose, which may have contributed to lower Hbg increase with the 250 mg dose at endpoint.
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
Layout table for Results Point of Contact information
Name/Title: Gary Hoel, RPh, PhD
Organization: Watson Laboratories, Inc
Phone: 801-588-6641
EMail: gary.hoel@watson.com
Layout table for additonal information
Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00223977     History of Changes
Other Study ID Numbers: FR03001
First Submitted: September 13, 2005
First Posted: September 22, 2005
Results First Submitted: August 19, 2009
Results First Posted: September 28, 2009
Last Update Posted: July 8, 2013