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

• Sponsor: Charles Drew University of Medicine and Science (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00604565
• Collaborator: National Institutes of Health (NIH) (NIH), Rockwell Medical Technologies, Inc. (Industry)
• Enrollment: 11
• Locations: 2
• Arms: 2
• Duration (Months): 35
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

In maintenance hemodialysis patients, regular administration of parenteral iron by addition of soluble ferric pyrophosphate (SFP) to the dialysate, when compared to conventional dialysate, is effective in preventing the development of iron deficiency, thereby maintaining hemoglobin level; is clinically safe and does not lead to oxidative stress or inflammation.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease (ESRD)	Drug: soluble ferric pyrophosphate (SFP); Other: placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: A Prospective, Randomized, Open-label, Multi-center, Controlled Clinical Trial of the Safety and Efficacy of Physiological Iron Maintenance in End Stage Renal Disease (ESRD) Subjects by Delivery of Soluble Ferric Pyrophosphate (SFP) Via Hemodialysate
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SFP dialysate dialysate with added soluble ferric pyrophosphate (SFP)	Drug: soluble ferric pyrophosphate (SFP); Subjects will be randomized to undergo dialysis with either 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). Control concentrate lacking SFP (C-HD) does not contain SFP (total iron = 0)
Placebo Comparator: standard dialysate standard dialysate without soluble ferric pyrophosphate (SFP)	Other: placebo; Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)

Outcome Measures

Primary Outcome Measures

1. TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS [36 weeks]

   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.

2. TOTAL NUMBER OF ADVERSE EVENTS [36 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:Subjects with end stage renal disease undergoing maintenance hemodialysis three times a week.

• Subjects who have required IV iron at any time in the 2 months preceding enrollment.

Exclusion Criteria:

• Subjects with absolute iron deficiency at the time of enrollment In hemodialysis subjects "absolute iron deficiency"

• Subjects with a current malignancy involving sites other than skin.

• Subjects with a history of drug or alcohol abuse within the last 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RAI	Los Angeles	California	United States	90059
2	University of Louisville Kidney Disease Program	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• Charles Drew University of Medicine and Science
• National Institutes of Health (NIH)
• Rockwell Medical Technologies, Inc.

Investigators

• Principal Investigator: Ajay Gupta, MD, Rockwell Medical Technologies, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ajay Gupta, Ajay Gupta, MD, Charles Drew University of Medicine and Science
• ClinicalTrials.gov Identifier: NCT00604565
• Other Study ID Numbers: SFP-NIH-01; NIH-FP-01
• First Posted: Jan 30, 2008
• Last Update Posted: Aug 31, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Ajay Gupta, Ajay Gupta, MD, Charles Drew University of Medicine and Science: Hemodialysis
• Additional relevant MeSH terms: Kidney Diseases; Kidney Failure, Chronic

Study Results

Participant Flow

Arm/Group Title	SFP Dialysate	Standard Dialysate
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

Baseline Characteristics

Arm/Group Title	SFP Dialysate	Standard Dialysate	Total
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 Participants	4	7	11
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	51.5	55.4	54.0
Sex: Female, Male (Count of Participants)
Female	3 75%	5 71.4%	8 72.7%
Male	1 25%	2 28.6%	3 27.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 75%	2 28.6%	5 45.5%
Not Hispanic or Latino	1 25%	5 71.4%	6 54.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 25%	5 71.4%	6 54.5%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 75%	2 28.6%	5 45.5%
Region of Enrollment (participants) [Number]
United States	4 100%	7 100%	11 100%

Outcome Measures

1. Primary Outcome

Title	TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS
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

Outcome Measure Data

Analysis Population Description

All subjects were included in the Safety Analysis population.

Arm/Group Title	SFP Dialysate	Standard Dialysate
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)
Measure Participants	4	7
Number of Subjects Who Experienced Serious AE	0 0%	1 14.3%
Number of Subjects Who Experienced Non-serious AE	4 100%	7 100%

2. Primary Outcome

Title	TOTAL NUMBER OF ADVERSE EVENTS
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

Outcome Measure Data

Analysis Population Description

All subjects were included in the Safety Analysis population.

Arm/Group Title	SFP Dialysate	Standard Dialysate
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)
Measure Participants	4	7
Total Number of Serious Adverse Events (SAEs)	0	1
Total Number of Non-Serious Adverse Events	66	115

Adverse Events

Arm/Group Title	SFP Dialysate		Standard Dialysate
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	SFP Dialysate		Standard Dialysate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		1/7 (14.3%)
Cardiac disorders
Chest Pain	0/4 (0%)	0	1/7 (14.3%)	1
Other (Not Including Serious) Adverse Events
	SFP Dialysate		Standard Dialysate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/4 (100%)		7/7 (100%)
Cardiac disorders
Bradycardia	0/4 (0%)	0	1/7 (14.3%)	1
Tachycardia	1/4 (25%)	1	3/7 (42.9%)	7
Eye disorders
Blindness	1/4 (25%)	1	0/7 (0%)	0
Eye Haemorrhage	0/4 (0%)	0	2/7 (28.6%)	2
Eyelid Oedema	0/4 (0%)	0	1/7 (14.3%)	1
Visual Acuity Reduced	0/4 (0%)	0	1/7 (14.3%)	1
Gastrointestinal disorders
Abdominal Pain	0/4 (0%)	0	1/7 (14.3%)	1
Diarrhoea	1/4 (25%)	1	1/7 (14.3%)	2
Nausea	2/4 (50%)	2	3/7 (42.9%)	3
Vomiting	1/4 (25%)	1	3/7 (42.9%)	3
General disorders
Asthenia	0/4 (0%)	0	1/7 (14.3%)	1
Chest Pain	1/4 (25%)	1	1/7 (14.3%)	2
Device Leakage	1/4 (25%)	1	0/7 (0%)	0
Face Oedema	0/4 (0%)	0	1/7 (14.3%)	1
Fatigue	0/4 (0%)	0	1/7 (14.3%)	1
Pyrexia	1/4 (25%)	1	1/7 (14.3%)	1
Thrombosis in Device	1/4 (25%)	1	0/7 (0%)	0
Infections and infestations
Cellulitis	1/4 (25%)	1	0/7 (0%)	0
Gingival Infection	0/4 (0%)	0	1/7 (14.3%)	1
Nasopharyngitis	0/4 (0%)	0	3/7 (42.9%)	3
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Complication	0/4 (0%)	0	1/7 (14.3%)	1
Arteriovenous Fistula Thrombosis	0/4 (0%)	0	1/7 (14.3%)	1
Contusion	0/4 (0%)	0	1/7 (14.3%)	1
Haemodialysis Complication	0/4 (0%)	0	1/7 (14.3%)	1
Haemodialysis-induced Symptom	2/4 (50%)	4	1/7 (14.3%)	2
Post-traumatic Pain	0/4 (0%)	0	1/7 (14.3%)	1
Procedural Hypertension	2/4 (50%)	2	3/7 (42.9%)	7
Procedural Hypotension	3/4 (75%)	6	4/7 (57.1%)	8
Traumatic Arthropathy	0/4 (0%)	0	1/7 (14.3%)	1
Vascular Access Complication	0/4 (0%)	0	2/7 (28.6%)	2
Vascular Graft Thrombosis	0/4 (0%)	0	1/7 (14.3%)	2
Investigations
Blood Pressure Diastolic Increased	0/4 (0%)	0	1/7 (14.3%)	1
Breath Sounds Abnormal	2/4 (50%)	2	2/7 (28.6%)	4
Cardiac Murmur	0/4 (0%)	0	1/7 (14.3%)	1
Carotid Bruit	0/4 (0%)	0	1/7 (14.3%)	1
Metabolism and nutrition disorders
Decreased Appetite	0/4 (0%)	0	1/7 (14.3%)	1
Fluid Retention	0/4 (0%)	0	2/7 (28.6%)	2
Hyperlipidaemia	0/4 (0%)	0	1/7 (14.3%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/4 (25%)	1	2/7 (28.6%)	2
Muscle Spasms	3/4 (75%)	9	1/7 (14.3%)	1
Musculoskeletal Pain	0/4 (0%)	0	2/7 (28.6%)	2
Pain in Extremity	0/4 (0%)	0	3/7 (42.9%)	7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Skin	0/4 (0%)	0	1/7 (14.3%)	1
Nervous system disorders
Dizziness	3/4 (75%)	13	3/7 (42.9%)	6
Headache	1/4 (25%)	1	3/7 (42.9%)	4
Hypoaesthesia	0/4 (0%)	0	1/7 (14.3%)	1
Respiratory, thoracic and mediastinal disorders
Cough	0/4 (0%)	0	1/7 (14.3%)	1
Dyspnoea	1/4 (25%)	1	1/7 (14.3%)	1
Nasal Congestion	1/4 (25%)	1	0/7 (0%)	0
Oropharyngeal Pain	0/4 (0%)	0	1/7 (14.3%)	1
Rales	1/4 (25%)	8	3/7 (42.9%)	6
Rhinorrhoea	1/4 (25%)	1	1/7 (14.3%)	1
Rhonchi	0/4 (0%)	0	1/7 (14.3%)	1
Wheezing	0/4 (0%)	0	1/7 (14.3%)	1
Skin and subcutaneous tissue disorders
Erythema	1/4 (25%)	1	0/7 (0%)	0
Pruritus	0/4 (0%)	0	1/7 (14.3%)	1
Swelling	1/4 (25%)	1	0/7 (0%)	0
Urticaria	1/4 (25%)	1	0/7 (0%)	0
Vascular disorders
Air Embolism	0/4 (0%)	0	1/7 (14.3%)	1
Flushing	1/4 (25%)	1	0/7 (0%)	0
Hypertension	1/4 (25%)	2	2/7 (28.6%)	6
Hypotension	0/4 (0%)	0	1/7 (14.3%)	1
Peripheral Coldness	0/4 (0%)	0	1/7 (14.3%)	1

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT 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.