Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Triferic Pediatric Pharmacokinetic Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02595437
Recruitment Status : Completed
First Posted : November 3, 2015
Results First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Rockwell Medical Technologies, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition End Stage Renal Disease
Intervention Drug: Triferic
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Triferic Via IV and Hemodialysate
Hide Arm/Group Description Triferic was administered via IV infusion on study Day 1, and then mixed with the liquid bicarbonate and administered via hemodialysate on study Day 3.
Period Title: Triferic Via IV
Started 22
Completed 21
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Period Title: Triferic Via Hemodialysate
Started 21
Completed 21
Not Completed 0
Arm/Group Title Safety Population
Hide Arm/Group Description All patients enrolled in the study who received any amount of Triferic, regardless of whether the dose was administered intravenously or via dialysate.
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
11.8  (4.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
11
  50.0%
Male
11
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Hispanic or Latino
9
  40.9%
Not Hispanic or Latino
12
  54.5%
Unknown or Not Reported
1
   4.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   4.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
  36.4%
White
8
  36.4%
More than one race
0
   0.0%
Unknown or Not Reported
5
  22.7%
1.Primary Outcome
Title Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: Cmax.
Hide Description The PK will be done by assessing the mean absolute and baseline-corrected Cmax of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute Cmax includes the concentration of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
Time Frame 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)
Arm/Group Title Triferic 0.07 mg/kg Iron Intravenous: Absolute Value Triferic 0.07 mg/kg Iron Intravenous: Baseline Corrected
Hide Arm/Group Description:
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are the absolute values.
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are baseline-corrected.
Overall Number of Participants Analyzed 21 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram/deciliter
217
(28.0%)
114
(53.7%)
2.Primary Outcome
Title Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(Last).
Hide Description The PK will be done by assessing the mean absolute and baseline-corrected AUC(last) of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute AUC(last) includes iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected AUC(last) factors out the iron present in the serum prior to dosing and includes the administered iron only.
Time Frame 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)
Arm/Group Title Triferic 0.07 mg/kg Iron Intravenous: Absolute Value Triferic 0.07 mg/kg Iron Intravenous: Baseline Corrected
Hide Arm/Group Description:
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are the absolute values.
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are baseline-corrected.
Overall Number of Participants Analyzed 21 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours* micrograms/ deciliters
1324
(36.5%)
419
(101.6%)
3.Primary Outcome
Title Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(0-end).
Hide Description The PK will be done by assessing the mean absolute and baseline-corrected AUC(0-end) of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute AUC (0-end) includes iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected AUC (0-end) factors out the iron present in the serum prior to dosing and includes the administered iron only.
Time Frame 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)
Arm/Group Title Triferic 0.07 mg/kg Iron Intravenous: Absolute Value Triferic 0.07 mg/kg Iron Intravenous: Baseline Corrected
Hide Arm/Group Description:
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are the absolute values.
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are baseline-corrected.
Overall Number of Participants Analyzed 21 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours* micrograms/ deciliters
648
(29.3%)
237
(76.8%)
4.Secondary Outcome
Title Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: Cmax.
Hide Description The PK will be done by assessing the mean absolute and baseline-corrected Cmax of total iron. The absolute Cmax includes the concentration of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
Time Frame 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)
Arm/Group Title Triferic 2 Micromolar in the Hemodialysate: Absolute Value Triferic 2 Micromolar in the Hemodialysate: Baseline Corrected
Hide Arm/Group Description:
Patients were administered Triferic at a concentration of 2 micromolar in the hemodialysate. The results for this group are the absolute values.
Patients were administered Triferic at a concentration of 2 micromolar in the hemodialysate. The results for this group are baseline-corrected.
Overall Number of Participants Analyzed 21 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms/ deciliters
261
(26.4%)
166
(54.3%)
5.Secondary Outcome
Title Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(Last).
Hide Description The PK will be done by assessing the mean absolute and baseline-corrected AUC(last) of total iron. The absolute AUC (last) includes the iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
Time Frame 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)
Arm/Group Title Triferic 2 Micromolar Via Hemodialysate: Absolute Value Triferic 2 Micromolar Via Hemodialysate: Baseline Corrected
Hide Arm/Group Description:
Patients were administered Triferic at a concentration of 2 micromolar in the hemodialysate. The results for this group are the absolute values.
Patients were administered Triferic at a concentration of 2 micromolar in the hemodialysate. The results for this group are baseline-corrected.
Overall Number of Participants Analyzed 21 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours* micrograms/ deciliters
1453
(59.6%)
682
(82.9%)
6.Secondary Outcome
Title Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(0-end).
Hide Description The PK will be done by assessing the mean absolute and baseline-corrected AUC(0-end) of total iron. The absolute AUC (0-end) includes the of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
Time Frame 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)
Arm/Group Title Triferic 2 Micromolar Via Hemodialysate: Absolute Value Triferic 2 Micromolar Via Hemodialysate: Baseline Corrected
Hide Arm/Group Description:
Patients were administered Triferic at a concentration of 2 micromolar in the hemodialysate. The results for this group are the absolute values.
Patients were administered Triferic at a concentration of 2 micromolar in the hemodialysate. The results for this group are baseline-corrected.
Overall Number of Participants Analyzed 21 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours* micrograms/ deciliters
763
(38.5%)
387
(79.6%)
7.Other Pre-specified Outcome
Title Treatment-emergent Adverse Events (TEAEs)
Hide Description The incidence of treatment-emergent AEs (TEAEs) and treatment-emergent serious AEs (TESAEs) will be grouped by body system. Adverse events were recorded from study Day 1 through the following up visit (approximately 1.5 weeks).
Time Frame 1.5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all patients who received any amount of study medication are included in the safety population.
Arm/Group Title IV Exposure IV and Hemodialysate Exposure
Hide Arm/Group Description:
Patients in this population had been exposed to Triferic via IV infusion only at the time of onset of the adverse event.
Patients in this population had been exposed to Triferic via the IV infusion and via hemodialysate at the time of the onset of the adverse event.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
4
  18.2%
3
  14.3%
Time Frame 1.5 weeks
Adverse Event Reporting Description Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
 
Arm/Group Title IV Exposure IV and Hemodialysate Exposure
Hide Arm/Group Description Patients in this population had received Triferic via IV infusion only at the time of onset of the adverse event. Patients in this population had received Triferic via IV infusion and via hemodialysate at the time of onset of the adverse event.
All-Cause Mortality
IV Exposure IV and Hemodialysate Exposure
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      0/21 (0.00%)    
Hide Serious Adverse Events
IV Exposure IV and Hemodialysate Exposure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/21 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV Exposure IV and Hemodialysate Exposure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/22 (18.18%)      3/21 (14.29%)    
Cardiac disorders     
Tachycardia  1  0/22 (0.00%)  0 1/21 (4.76%)  1
Gastrointestinal disorders     
Nausea  1  2/22 (9.09%)  2 0/21 (0.00%)  0
Abdominal Pain  1  1/22 (4.55%)  1 0/21 (0.00%)  0
Abdominal pain upper  1  1/22 (4.55%)  1 0/21 (0.00%)  0
Constipation  1  0/22 (0.00%)  0 1/21 (4.76%)  1
General disorders     
Axillary Pain  1  0/22 (0.00%)  0 1/21 (4.76%)  1
Musculoskeletal and connective tissue disorders     
Back Pain  1  1/22 (4.55%)  1 0/21 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/22 (4.55%)  1 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/22 (4.55%)  1 0/21 (0.00%)  0
Vascular disorders     
Hypotension  1  0/22 (0.00%)  0 1/21 (4.76%)  1
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Project Manager
Organization: Rockwell Medical, Inc
Phone: 248-960-9009
EMail: sgrimberg@rockwellmed.com
Layout table for additonal information
Responsible Party: Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02595437    
Other Study ID Numbers: RMFPC-11
First Submitted: October 30, 2015
First Posted: November 3, 2015
Results First Submitted: August 27, 2018
Results First Posted: October 25, 2018
Last Update Posted: October 25, 2018