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Trial record 72 of 380 for:    FERRIC CATION

Delivery of Soluble Ferric Pyrophosphate (SFP) Via the Dialysate to Maintain Iron Balance in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT00604565
Recruitment Status : Terminated (major planned changes to study design)
First Posted : January 30, 2008
Results First Posted : August 31, 2015
Last Update Posted : August 31, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Rockwell Medical Technologies, Inc.
Information provided by (Responsible Party):
Ajay Gupta, Charles Drew University of Medicine and Science

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition End Stage Renal Disease (ESRD)
Interventions Drug: soluble ferric pyrophosphate (SFP)
Other: placebo
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SFP Dialysate Standard Dialysate
Hide Arm/Group Description

dialysate with added soluble ferric pyrophosphate (SFP)

soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL).

standard dialysate without soluble ferric pyrophosphate (SFP)

placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)

Period Title: Overall Study
Started 4 7
Completed 4 4
Not Completed 0 3
Reason Not Completed
Study terminated             0             3
Arm/Group Title SFP Dialysate Standard Dialysate Total
Hide Arm/Group Description

dialysate with added soluble ferric pyrophosphate (SFP)

soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL).

standard dialysate without soluble ferric pyrophosphate (SFP)

placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)

Total of all reporting groups
Overall Number of Baseline Participants 4 7 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 7 participants 11 participants
51.5
(39 to 67)
55.4
(41 to 65)
54.0
(39 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 7 participants 11 participants
Female
3
  75.0%
5
  71.4%
8
  72.7%
Male
1
  25.0%
2
  28.6%
3
  27.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 7 participants 11 participants
Hispanic or Latino
3
  75.0%
2
  28.6%
5
  45.5%
Not Hispanic or Latino
1
  25.0%
5
  71.4%
6
  54.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 7 participants 11 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  25.0%
5
  71.4%
6
  54.5%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
  75.0%
2
  28.6%
5
  45.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 7 participants 11 participants
4 7 11
1.Primary Outcome
Title TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS
Hide Description Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of subjects affected are listed only. The details of the types of events that took place are reported in the Adverse Events section.
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were included in the Safety Analysis population.
Arm/Group Title SFP Dialysate Standard Dialysate
Hide Arm/Group Description:

dialysate with added soluble ferric pyrophosphate (SFP)

soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL).

standard dialysate without soluble ferric pyrophosphate (SFP)

placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)

Overall Number of Participants Analyzed 4 7
Measure Type: Number
Unit of Measure: participants
Number of Subjects Who Experienced Serious AE 0 1
Number of Subjects Who Experienced Non-serious AE 4 7
2.Primary Outcome
Title TOTAL NUMBER OF ADVERSE EVENTS
Hide Description Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of events are listed only. The details of the types of events that took place are reported in the Adverse Events section.
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were included in the Safety Analysis population.
Arm/Group Title SFP Dialysate Standard Dialysate
Hide Arm/Group Description:

dialysate with added soluble ferric pyrophosphate (SFP)

soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL).

standard dialysate without soluble ferric pyrophosphate (SFP)

placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)

Overall Number of Participants Analyzed 4 7
Measure Type: Number
Unit of Measure: events
Total Number of Serious Adverse Events (SAEs) 0 1
Total Number of Non-Serious Adverse Events 66 115
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SFP Dialysate Standard Dialysate
Hide Arm/Group Description

dialysate with added soluble ferric pyrophosphate (SFP)

soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL).

standard dialysate without soluble ferric pyrophosphate (SFP)

placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)

All-Cause Mortality
SFP Dialysate Standard Dialysate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SFP Dialysate Standard Dialysate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      1/7 (14.29%)    
Cardiac disorders     
Chest Pain   0/4 (0.00%)  0 1/7 (14.29%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SFP Dialysate Standard Dialysate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      7/7 (100.00%)    
Cardiac disorders     
Bradycardia   0/4 (0.00%)  0 1/7 (14.29%)  1
Tachycardia   1/4 (25.00%)  1 3/7 (42.86%)  7
Eye disorders     
Blindness   1/4 (25.00%)  1 0/7 (0.00%)  0
Eye Haemorrhage   0/4 (0.00%)  0 2/7 (28.57%)  2
Eyelid Oedema   0/4 (0.00%)  0 1/7 (14.29%)  1
Visual Acuity Reduced   0/4 (0.00%)  0 1/7 (14.29%)  1
Gastrointestinal disorders     
Abdominal Pain   0/4 (0.00%)  0 1/7 (14.29%)  1
Diarrhoea   1/4 (25.00%)  1 1/7 (14.29%)  2
Nausea   2/4 (50.00%)  2 3/7 (42.86%)  3
Vomiting   1/4 (25.00%)  1 3/7 (42.86%)  3
General disorders     
Asthenia   0/4 (0.00%)  0 1/7 (14.29%)  1
Chest Pain   1/4 (25.00%)  1 1/7 (14.29%)  2
Device Leakage   1/4 (25.00%)  1 0/7 (0.00%)  0
Face Oedema   0/4 (0.00%)  0 1/7 (14.29%)  1
Fatigue   0/4 (0.00%)  0 1/7 (14.29%)  1
Pyrexia   1/4 (25.00%)  1 1/7 (14.29%)  1
Thrombosis in Device   1/4 (25.00%)  1 0/7 (0.00%)  0
Infections and infestations     
Cellulitis   1/4 (25.00%)  1 0/7 (0.00%)  0
Gingival Infection   0/4 (0.00%)  0 1/7 (14.29%)  1
Nasopharyngitis   0/4 (0.00%)  0 3/7 (42.86%)  3
Injury, poisoning and procedural complications     
Arteriovenous Fistula Site Complication   0/4 (0.00%)  0 1/7 (14.29%)  1
Arteriovenous Fistula Thrombosis   0/4 (0.00%)  0 1/7 (14.29%)  1
Contusion   0/4 (0.00%)  0 1/7 (14.29%)  1
Haemodialysis Complication   0/4 (0.00%)  0 1/7 (14.29%)  1
Haemodialysis-induced Symptom   2/4 (50.00%)  4 1/7 (14.29%)  2
Post-traumatic Pain   0/4 (0.00%)  0 1/7 (14.29%)  1
Procedural Hypertension   2/4 (50.00%)  2 3/7 (42.86%)  7
Procedural Hypotension   3/4 (75.00%)  6 4/7 (57.14%)  8
Traumatic Arthropathy   0/4 (0.00%)  0 1/7 (14.29%)  1
Vascular Access Complication   0/4 (0.00%)  0 2/7 (28.57%)  2
Vascular Graft Thrombosis   0/4 (0.00%)  0 1/7 (14.29%)  2
Investigations     
Blood Pressure Diastolic Increased   0/4 (0.00%)  0 1/7 (14.29%)  1
Breath Sounds Abnormal   2/4 (50.00%)  2 2/7 (28.57%)  4
Cardiac Murmur   0/4 (0.00%)  0 1/7 (14.29%)  1
Carotid Bruit   0/4 (0.00%)  0 1/7 (14.29%)  1
Metabolism and nutrition disorders     
Decreased Appetite   0/4 (0.00%)  0 1/7 (14.29%)  1
Fluid Retention   0/4 (0.00%)  0 2/7 (28.57%)  2
Hyperlipidaemia   0/4 (0.00%)  0 1/7 (14.29%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia   1/4 (25.00%)  1 2/7 (28.57%)  2
Muscle Spasms   3/4 (75.00%)  9 1/7 (14.29%)  1
Musculoskeletal Pain   0/4 (0.00%)  0 2/7 (28.57%)  2
Pain in Extremity   0/4 (0.00%)  0 3/7 (42.86%)  7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm Skin   0/4 (0.00%)  0 1/7 (14.29%)  1
Nervous system disorders     
Dizziness   3/4 (75.00%)  13 3/7 (42.86%)  6
Headache   1/4 (25.00%)  1 3/7 (42.86%)  4
Hypoaesthesia   0/4 (0.00%)  0 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders     
Cough   0/4 (0.00%)  0 1/7 (14.29%)  1
Dyspnoea   1/4 (25.00%)  1 1/7 (14.29%)  1
Nasal Congestion   1/4 (25.00%)  1 0/7 (0.00%)  0
Oropharyngeal Pain   0/4 (0.00%)  0 1/7 (14.29%)  1
Rales   1/4 (25.00%)  8 3/7 (42.86%)  6
Rhinorrhoea   1/4 (25.00%)  1 1/7 (14.29%)  1
Rhonchi   0/4 (0.00%)  0 1/7 (14.29%)  1
Wheezing   0/4 (0.00%)  0 1/7 (14.29%)  1
Skin and subcutaneous tissue disorders     
Erythema   1/4 (25.00%)  1 0/7 (0.00%)  0
Pruritus   0/4 (0.00%)  0 1/7 (14.29%)  1
Swelling   1/4 (25.00%)  1 0/7 (0.00%)  0
Urticaria   1/4 (25.00%)  1 0/7 (0.00%)  0
Vascular disorders     
Air Embolism   0/4 (0.00%)  0 1/7 (14.29%)  1
Flushing   1/4 (25.00%)  1 0/7 (0.00%)  0
Hypertension   1/4 (25.00%)  2 2/7 (28.57%)  6
Hypotension   0/4 (0.00%)  0 1/7 (14.29%)  1
Peripheral Coldness   0/4 (0.00%)  0 1/7 (14.29%)  1
Indicates events were collected by systematic assessment
Study suspended after 1st 11 subjects enrolled. Study design changed significantly upon re-initiation, so 1st 11 subjects analyzed for safety only; no efficacy. Efficacy analysis from study after re-initiation is found under protocol NIH-FP-01 PRIME.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ajay Gupta, MD
Organization: Rockwell Medical
Phone: 248-960-9009
EMail: rd@rockwellmed.com
Layout table for additonal information
Responsible Party: Ajay Gupta, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00604565     History of Changes
Other Study ID Numbers: SFP-NIH-01
NIH-FP-01
First Submitted: January 17, 2008
First Posted: January 30, 2008
Results First Submitted: March 11, 2015
Results First Posted: August 31, 2015
Last Update Posted: August 31, 2015