| Trial ID: | L1001 |
| Source ID: | NCT00604565
|
| Associated Drug: |
Soluble Ferric Pyrophosphate (Sfp)
|
| Title: |
Delivery of Soluble Ferric Pyrophosphate (SFP) Via the Dialysate to Maintain Iron Balance in Hemodialysis Patients
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00604565/results
|
| Conditions: |
End Stage Renal Disease (ESRD)
|
| Interventions: |
DRUG: soluble ferric pyrophosphate (SFP)|OTHER: placebo
|
| Outcome Measures: |
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., 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 |
|
| Sponsor/Collaborators: |
Sponsor: Charles Drew University of Medicine and Science | Collaborators: National Institutes of Health (NIH)|Rockwell Medical Technologies, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
11
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
|
| Start Date: |
2008-01
|
| Completion Date: |
2010-12
|
| Results First Posted: |
2015-08-31
|
| Last Update Posted: |
2015-08-31
|
| Locations: |
RAI, Los Angeles, California, 90059, United States|University of Louisville Kidney Disease Program, Louisville, Kentucky, 40202, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00604565
|
