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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)


Participant Flow:   Overall Study
    SFP Dialysate   Standard Dialysate
STARTED   4   7 
COMPLETED   4   4 
NOT COMPLETED   0   3 
Study terminated                0                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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)

Total Total of all reporting groups

Baseline Measures
   SFP Dialysate   Standard Dialysate   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   7   11 
Age 
[Units: Years]
Mean (Full Range)
 51.5 
 (39 to 67) 
 55.4 
 (41 to 65) 
 54.0 
 (39 to 67) 
Gender 
[Units: Participants]
     
Female   3   5   8 
Male   1   2   3 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   3   2   5 
Not Hispanic or Latino   1   5   6 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   1   5   6 
White   0   0   0 
More than one race   0   0   0 
Unknown or Not Reported   3   2   5 
Region of Enrollment 
[Units: Participants]
     
United States   4   7   11 


  Outcome Measures

1.  Primary:   TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS   [ Time Frame: 36 weeks ]

2.  Primary:   TOTAL NUMBER OF ADVERSE EVENTS   [ Time Frame: 36 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


Results Point of Contact:  
Name/Title: Ajay Gupta, MD
Organization: Rockwell Medical
phone: 248-960-9009
e-mail: rd@rockwellmed.com



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