Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NIH-FP-01 |
Not provided
Not provided
Not provided
major planned changes to study design
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Rockwell Medical Technologies, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SFP dialysate | Experimental | dialysate with added soluble ferric pyrophosphate (SFP) |
|
| standard dialysate | Placebo Comparator | standard dialysate without soluble ferric pyrophosphate (SFP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soluble ferric pyrophosphate (SFP) | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS | 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. | 36 weeks |
| TOTAL NUMBER OF ADVERSE EVENTS | 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. | 36 weeks |
Not provided
Not provided
Inclusion Criteria:Subjects with end stage renal disease undergoing maintenance hemodialysis three times a week.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ajay Gupta, MD | Rockwell Medical Technologies, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RAI | Los Angeles | California | 90059 | United States | ||
| University of Louisville Kidney Disease Program |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| placebo | Other | Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP) |
|
| Louisville |
| Kentucky |
| 40202 |
| United States |
| FG001 |
| Standard Dialysate |
standard dialysate without soluble ferric pyrophosphate (SFP) placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Standard Dialysate | standard dialysate without soluble ferric pyrophosphate (SFP) placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS | 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. | All subjects were included in the Safety Analysis population. | Posted | Number | participants | 36 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | TOTAL NUMBER OF ADVERSE EVENTS | 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. | All subjects were included in the Safety Analysis population. | Posted | Number | events | 36 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 4 | 4 | 4 | ||
| EG001 | Standard Dialysate | standard dialysate without soluble ferric pyrophosphate (SFP) placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP) | 1 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Air Embolism | Vascular disorders | Systematic Assessment |
| ||
| Arteriovenous Fistula Site Complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Arteriovenous Fistula Thrombosis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Blindness | Eye disorders | Systematic Assessment |
| ||
| Blood Pressure Diastolic Increased | Investigations | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Breath Sounds Abnormal | Investigations | Systematic Assessment |
| ||
| Cardiac Murmur | Investigations | Systematic Assessment |
| ||
| Carotid Bruit | Investigations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Chest Pain | General disorders | Systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Device Leakage | General disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Eye Haemorrhage | Eye disorders | Systematic Assessment |
| ||
| Eyelid Oedema | Eye disorders | Systematic Assessment |
| ||
| Face Oedema | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Fluid Retention | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Flushing | Vascular disorders | Systematic Assessment |
| ||
| Gingival Infection | Infections and infestations | Systematic Assessment |
| ||
| Haemodialysis Complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Haemodialysis-induced Symptom | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hyperlipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neoplasm Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Peripheral Coldness | Vascular disorders | Systematic Assessment |
| ||
| Post-traumatic Pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural Hypertension | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural Hypotension | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Rales | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhonchi | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Thrombosis in Device | General disorders | Systematic Assessment |
| ||
| Traumatic Arthropathy | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Vascular Access Complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular Graft Thrombosis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Visual Acuity Reduced | Eye disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | 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.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ajay Gupta, MD | Rockwell Medical | 248-960-9009 | rd@rockwellmed.com |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|