Trial Outcomes & Findings for Delivery of Soluble Ferric Pyrophosphate (SFP) Via the Dialysate to Maintain Iron Balance in Hemodialysis Patients (NCT NCT00604565)
NCT ID: NCT00604565
Last Updated: 2015-08-31
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
36 weeks
Results posted on
2015-08-31
Participant Flow
Participant milestones
| Measure |
SFP Dialysate
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
standard dialysate without soluble ferric pyrophosphate (SFP)
placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
SFP Dialysate
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
standard dialysate without soluble ferric pyrophosphate (SFP)
placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)
|
|---|---|---|
|
Overall Study
Study terminated
|
0
|
3
|
Baseline Characteristics
Delivery of Soluble Ferric Pyrophosphate (SFP) Via the Dialysate to Maintain Iron Balance in Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
SFP Dialysate
n=4 Participants
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
n=7 Participants
standard dialysate without soluble ferric pyrophosphate (SFP)
placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.5 years
n=99 Participants
|
55.4 years
n=107 Participants
|
54.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
7 participants
n=107 Participants
|
11 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 36 weeksPopulation: All subjects were included in the Safety Analysis population.
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.
Outcome measures
| Measure |
SFP Dialysate
n=4 Participants
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
n=7 Participants
standard dialysate without soluble ferric pyrophosphate (SFP)
placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)
|
|---|---|---|
|
TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS
Number of Subjects Who Experienced Serious AE
|
0 participants
|
1 participants
|
|
TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS
Number of Subjects Who Experienced Non-serious AE
|
4 participants
|
7 participants
|
PRIMARY outcome
Timeframe: 36 weeksPopulation: All subjects were included in the Safety Analysis population.
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.
Outcome measures
| Measure |
SFP Dialysate
n=4 Participants
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
n=7 Participants
standard dialysate without soluble ferric pyrophosphate (SFP)
placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)
|
|---|---|---|
|
TOTAL NUMBER OF ADVERSE EVENTS
Total Number of Serious Adverse Events (SAEs)
|
0 events
|
1 events
|
|
TOTAL NUMBER OF ADVERSE EVENTS
Total Number of Non-Serious Adverse Events
|
66 events
|
115 events
|
Adverse Events
SFP Dialysate
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Standard Dialysate
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SFP Dialysate
n=4 participants at risk
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
n=7 participants at risk
standard dialysate without soluble ferric pyrophosphate (SFP)
placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)
|
|---|---|---|
|
Cardiac disorders
Chest Pain
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
Other adverse events
| Measure |
SFP Dialysate
n=4 participants at risk
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
n=7 participants at risk
standard dialysate without soluble ferric pyrophosphate (SFP)
placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Vascular disorders
Air Embolism
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Complication
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Thrombosis
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Asthenia
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Eye disorders
Blindness
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Blood Pressure Diastolic Increased
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Breath Sounds Abnormal
|
50.0%
2/4 • Number of events 2
|
28.6%
2/7 • Number of events 4
|
|
Investigations
Cardiac Murmur
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Carotid Bruit
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Chest Pain
|
25.0%
1/4 • Number of events 1
|
14.3%
1/7 • Number of events 2
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Device Leakage
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1
|
14.3%
1/7 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
75.0%
3/4 • Number of events 13
|
42.9%
3/7 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Eye disorders
Eye Haemorrhage
|
0.00%
0/4
|
28.6%
2/7 • Number of events 2
|
|
Eye disorders
Eyelid Oedema
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Face Oedema
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.00%
0/4
|
28.6%
2/7 • Number of events 2
|
|
Vascular disorders
Flushing
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Gingival Infection
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Injury, poisoning and procedural complications
Haemodialysis Complication
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Injury, poisoning and procedural complications
Haemodialysis-induced Symptom
|
50.0%
2/4 • Number of events 4
|
14.3%
1/7 • Number of events 2
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1
|
42.9%
3/7 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 2
|
28.6%
2/7 • Number of events 6
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
75.0%
3/4 • Number of events 9
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/4
|
28.6%
2/7 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4
|
42.9%
3/7 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2
|
42.9%
3/7 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Skin
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/4
|
42.9%
3/7 • Number of events 7
|
|
Vascular disorders
Peripheral Coldness
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post-traumatic Pain
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural Hypertension
|
50.0%
2/4 • Number of events 2
|
42.9%
3/7 • Number of events 7
|
|
Injury, poisoning and procedural complications
Procedural Hypotension
|
75.0%
3/4 • Number of events 6
|
57.1%
4/7 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
25.0%
1/4 • Number of events 8
|
42.9%
3/7 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
25.0%
1/4 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Swelling
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Cardiac disorders
Tachycardia
|
25.0%
1/4 • Number of events 1
|
42.9%
3/7 • Number of events 7
|
|
General disorders
Thrombosis in Device
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Traumatic Arthropathy
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
0.00%
0/4
|
28.6%
2/7 • Number of events 2
|
|
Injury, poisoning and procedural complications
Vascular Graft Thrombosis
|
0.00%
0/4
|
14.3%
1/7 • Number of events 2
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1
|
42.9%
3/7 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place