ClinicalTrials.gg
Sign In
CompletedNCT02909153Updated Aug 8, 2019Results posted

Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis

A Phase 1 interventional study of Triferic in Peritoneal Dialysis (PD), Anemia and Chronic Kidney Disease, sponsored by Rockwell Medical Technologies, Inc.. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-08.

Sponsored by Rockwell Medical Technologies, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The main purpose is to determine the pharmacokinetic (PK) profile, maximum concentration (Cmax) and Area Under the Concentration Time Curve (AUC0-t) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). It is an open label, dose escalation study.

Read the detailed description

This is a phase 1, open-label, dose escalation study assessing the pharmacokinetic (PK) profile, maximum concentration (Cmax) and Area Under the Concentration Time Curve (AUC0-t) of Triferic iron administered intraperitoneally in chronic kidney disease patients on peritoneal dialysis (Continuous Cycling Peritoneal Dialysis (CCPD) or Continuous Ambulatory Peritoneal Dialysis (CAPD)).

Screening can be up to 4 weeks, and the enrollment period is approximately one week. There are two treatment (dosing) visits and one follow-up visit during the enrollment period.

At each treatment visit, the patients will be randomly assigned to receive either a single ascending dose of Triferic administered intraperitoneal (IP) during a long (12 hour) peritoneal dialysis dwell or a single 6.6 mg dose of Triferic administered IV over 4 hours. Blood samples will be obtained at defined times over 12 hours to establish the total serum iron PK of IP Triferic as well as the clinical serum iron profile.

The IP dose of the first Cohort will be 5 mg Triferic iron/liter IP. Subsequent Cohort IP doses will be 12.5 mg Triferic iron/liter, and 20 mg Triferic iron/liter, with the final Cohort dose to be determined (TBD). The IV dose will be 6.6. mg for all Cohorts. Six patients will be enrolled in each Cohort, with enrollment in the subsequent (higher dose) Cohort not being initiated until the completion and evaluation of the previous (lower dose) Cohort.

02

Conditions studied

  • Peritoneal Dialysis (PD)
  • Anemia
  • Chronic Kidney Disease

Keywords

  • Triferic
  • ferric pyrophosphate citrate (FPC)
  • peritoneal dialysis
  • anemia
  • chronic kidney disease
03

In context

Anemia

1,768 studies on the registry are indexed under Anemia; 244 are open to participants now.

This study's enrollment of 30 is below the median of 96 across 1,318 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Rockwell Medical Technologies, Inc. is the lead sponsor of 19 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The patient must be able to provide informed consent and have personally signed and dated the study written informed consent document before completing any study-related procedures.
  2. The patient must be 18-75 years of age inclusive at the time of consent.
  3. Have a diagnosis of End Stage Renal Disease and have been on Peritoneal Dialysis for at least 3 months (CAPD or CCPD) prior to Screening.
  4. Be in a stable clinical condition during the four weeks immediately prior to Screening Period as demonstrated by medical history, physical examination and laboratory testing
  5. Have a blood hemoglobin concentration above 9.5 g/dL.
  6. Have a total iron binding capacity (TIBC) of ≥ 175 µg/dL.
  7. Have not experienced peritonitis episodes in the last 3 months prior to Screening.
  8. The patient must agree to discontinue all iron preparations for 14 days prior to Study PD #1/Day 1.
  9. Female patients must be nonpregnant and not breastfeeding. They must either have been amenorrheic for the past year or agree to not become pregnant by continuous use of an effective birth control method acceptable to the Investigator for the duration of their participation in the study.

Exclusion criteria

Exclusion Criteria:

  1. The patient has had an red blood cell (RBC) or whole blood transfusion within 4 weeks prior to Screening.
  2. The patient has had administration of IV or oral iron supplements (including multivitamins with iron) within 14 days prior to Study PD #1/Day 1.
  3. The patient has known active bleeding from any site (e.g., gastrointestinal, hemorrhoid, nasal, pulmonary, etc.).
  4. The patient has a living kidney donor identified or living-donor kidney transplant scheduled to occur during study participation. (Note: Patients awaiting deceased-donor transplant need not be excluded.)
  5. The patient is scheduled to have a surgical procedure during the study.
  6. The patient has had a hospitalization within the 4 weeks prior to Screening (except for vascular access surgery) that, in the opinion of the Investigator, confers a significant risk of hospitalization during the course of the study.
  7. The patient has a history of noncompliance with the dialysis regimen in the opinion of the Investigator.
  8. The patient has a known ongoing inflammatory disorder (other than chronic kidney disease), such as systemic lupus erythematosus, rheumatoid arthritis, or other collagen-vascular disease, that currently requires systemic anti-inflammatory or immunomodulatory therapy.
  9. The patient has any current febrile illness (e.g., oral temperature ≥100.4°F, 38.0°C). (Patients may subsequently become eligible at least 1 week after resolution of the illness.)
  10. The patient has known bacterial, tuberculosis, fungal, viral, or parasitic infection requiring anti-microbial therapy or anticipated to require anti-microbial therapy during the patient's participation in this study.
  11. The patient is known to be positive for HIV, hepatitis B, or hepatitis C (viral testing is not required as part of this protocol).
  12. The patient has cirrhosis of the liver based on histological criteria or clinical criteria (e.g., presence of ascites, esophageal varices, multiple spider nevi, or history of hepatic encephalopathy).
  13. The patient has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels consistently greater than twice the upper limit of normal at any time during the two months prior to Study PD #1/Day 1.
  14. The patient currently has any malignancy other than basal or squamous cell skin cancer.
  15. The patient has a history of drug or alcohol abuse within the 6 months prior to Screening.
  16. The patient participated in an investigational drug study within 30 days prior to Study PD #1/Day 1.
  17. The patient has any condition that, in the opinion of the Investigator, would make it unlikely for the patient to complete the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    single dose of Triferic in the peritoneal dialysis solution

    The patient will receive a single dose of Triferic in the peritoneal dialysis solution (IP) during a long (12 hour) peritoneal dialysis dwell. Each Cohort will receive a different ascending IP dose ( 5 mg/L, 12.5 mg/L, 20 mg/L). Blood samples will be drawn periodically over a 12 hour period for analysis.

    Drug: Triferic

  • Experimental
    single IV dose of Triferic 6.6 mg over a 4 hour period

    The patient will receive a single 6.6 mg intravenous (IV) dose of Triferic in the over a 4 hour period. All Cohorts will receive the same IV dose. Blood samples will be drawn periodically over a 12 hour period for analysis.

    Drug: Triferic

Interventions

  • DrugTriferic

    Triferic is an iron salt that is approved by the FDA for the maintenance of hemoglobin in patients with end stage kidney disease on hemodialysis. It is experimental in this study because it has not yet been approved for patients on chronic peritoneal dialysis.

    Also known as: ferric pyrophosphate citrate, FPC

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intraperitoneal Administration of Triferic

    The PK will be done by assessing the mean absolute Cmax of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours

  2. Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intraperitoneal Administration of Triferic

    The PK will be done by assessing the AUC from time zero to the time of the last quantified concentration (AUClast) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours

  3. Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0 - 12 of Serum Total Iron After Intraperitoneal Administration of Triferic

    The PK will be done by assessing the AUC from time zero to 12 hours after infusion (AUC0-12) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours

  4. Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intravenous Administration of Triferic

    The PK will be done by assessing the mean absolute Cmax of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours

  5. Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intravenous Administration of Triferic

    The PK will be done by assessing the AUC from time zero to the time of the last quantified concentration (AUClast) of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours

  6. Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0-12 of Serum Total Iron After Intravenous Administration of Triferic

    The PK will be done by assessing the AUC from time zero to 12 hours after the infusion (AUC0-12) of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours

Secondary outcomes

  1. Bioavailability of Triferic Iron Administered Via PD Solution: F(Cmax)

    The bioavailability (F) of the maximum serum iron concentration (Cmax) of Triferic iron was quantified for the peritoneal dialysis dose of Triferic for all cohorts.

    Time frame: 12 hours

07

Results

Posted Aug 8, 2019

Participant flow

Participant flow — Overall Study
MilestoneCohort 1Cohort 2Cohort 3Cohort 4Cohort 5
Started66666
Triferic in dianeal pd solution66600
Triferic 6.6mg fe via 4hr iv infusions65666
Triferic in extraneal pd solution00066
Completed65666
Not completed01000
Withdrew: Withdrawal by subject01000

Outcome measures

PrimaryPharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intraperitoneal Administration of Triferic

The PK will be done by assessing the mean absolute Cmax of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).

Time frame:
0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours
Reported as:
Geometric mean · microgram per deciliter
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intraperitoneal Administration of Triferic
microgram per deciliterCohort 1Cohort 2Cohort 3Cohort 4Cohort 5
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intraperitoneal Administration of Triferic164 ± 25.0213 ± 3.78153 ± 32.1163 ± 19.4105 ± 15.9
PrimaryPharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intraperitoneal Administration of Triferic

The PK will be done by assessing the AUC from time zero to the time of the last quantified concentration (AUClast) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).

Time frame:
0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours
Reported as:
Geometric mean · hours x micrograms/ deciliters
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intraperitoneal Administration of Triferic
hours x micrograms/ decilitersCohort 1Cohort 2Cohort 3Cohort 4Cohort 5
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intraperitoneal Administration of Triferic1690 ± 27.92220 ± 9.842560 ± 33.02510 ± 41.82260 ± 23.9
PrimaryPharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0 - 12 of Serum Total Iron After Intraperitoneal Administration of Triferic

The PK will be done by assessing the AUC from time zero to 12 hours after infusion (AUC0-12) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).

Time frame:
0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours
Reported as:
Geometric mean · hours x micrograms/ deciliters
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0 - 12 of Serum Total Iron After Intraperitoneal Administration of Triferic
hours x micrograms/ decilitersCohort 1Cohort 2Cohort 3Cohort 4Cohort 5
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0 - 12 of Serum Total Iron After Intraperitoneal Administration of Triferic1690 ± 27.92220 ± 9.841580 ± 41.81610 ± 32.31050 ± 20.9
PrimaryPharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intravenous Administration of Triferic

The PK will be done by assessing the mean absolute Cmax of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).

Time frame:
0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours
Reported as:
Geometric mean · micrograms/ deciliters
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intravenous Administration of Triferic
micrograms/ decilitersCohort 1Cohort 2Cohort 3Cohort 4Cohort 5
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intravenous Administration of Triferic217 ± 41.9203 ± 32.6183 ± 30.3254212 ± 14.7177 ± 30.8
PrimaryPharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intravenous Administration of Triferic

The PK will be done by assessing the AUC from time zero to the time of the last quantified concentration (AUClast) of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).

Time frame:
0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours
Reported as:
Geometric mean · hours* micrograms/ deciliters
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intravenous Administration of Triferic
hours* micrograms/ decilitersCohort 1Cohort 2Cohort 3Cohort 4Cohort 5
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intravenous Administration of Triferic1750 ± 33.81730 ± 28.22160 ± 30.03060 ± 33.62840 ± 35.7
PrimaryPharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0-12 of Serum Total Iron After Intravenous Administration of Triferic

The PK will be done by assessing the AUC from time zero to 12 hours after the infusion (AUC0-12) of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).

Time frame:
0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours
Reported as:
Geometric mean · hours* micrograms/ deciliters
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0-12 of Serum Total Iron After Intravenous Administration of Triferic
hours* micrograms/ decilitersCohort 1Cohort 2Cohort 3Cohort 4Cohort 5
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0-12 of Serum Total Iron After Intravenous Administration of Triferic1750 ± 33.81730 ± 28.21530 ± 41.31890 ± 20.91560 ± 31.7
SecondaryBioavailability of Triferic Iron Administered Via PD Solution: F(Cmax)

The bioavailability (F) of the maximum serum iron concentration (Cmax) of Triferic iron was quantified for the peritoneal dialysis dose of Triferic for all cohorts.

Time frame:
12 hours
Reported as:
Geometric mean · percent of bioavailability
Bioavailability of Triferic Iron Administered Via PD Solution: F(Cmax)
percent of bioavailabilityCohort 1Cohort 2Cohort 3Cohort 4Cohort 5
Bioavailability of Triferic Iron Administered Via PD Solution: F(Cmax)47.7 ± 28.326.5 ± 30.934.9 ± 25.262.6 ± 17.374.6 ± 25.9

Adverse events

Collected over Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 10/6 (0%)0/6 (0%)1/6 (16.7%)
Cohort 20/6 (0%)0/6 (0%)2/6 (33.3%)
Cohort 30/6 (0%)0/6 (0%)1/6 (16.7%)
Cohort 40/6 (0%)0/6 (0%)1/6 (16.7%)
Cohort 50/6 (0%)0/6 (0%)0/6 (0%)
Most frequent other events
Most frequent other events
EventCohort 1Cohort 2Cohort 3Cohort 4Cohort 5
Abdominal PainGastrointestinal disorders0/61/61/60/60/6
NauseaGastrointestinal disorders0/61/61/60/60/6
VomitingGastrointestinal disorders0/61/61/60/60/6
Abdominal DiscomfortGastrointestinal disorders0/60/60/61/60/6
Groin PainMusculoskeletal and connective tissue disorders1/60/60/60/60/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Total
Mean62.3 ± 8.245.8 ± 19.656.7 ± 10.245.2 ± 21.556.3 ± 15.953.3 ± 16.3
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Total
Female1442314
Male5224316
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Total
Hispanic or Latino3233314
Not Hispanic or Latino3433316
Unknown or Not Reported000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Total
American Indian or Alaska Native000000
Asian000101
Native Hawaiian or Other Pacific Islander000000
Black or African American020125
White6464424
More than one race000000
Unknown or Not Reported000000
Region of Enrollment
Region of Enrollment(participants)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Total
United States6666630
08

Study locations

No study locations are listed for this record.

09

References and documents

Study documents

  • Study protocol · Nov 21, 2016
  • Statistical analysis plan · Jun 26, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02909153
Lead sponsor
Rockwell Medical Technologies, Inc.
Responsible party
Sponsor
First posted
Sep 21, 2016
Start date
Jan 2017
Primary completion
Jul 2017
Completion
Jul 2017
Results posted
Aug 8, 2019
Last update
Aug 8, 2019

Study contacts

Raymond D Pratt, MD, FACP
study director · Rockwell Medical, Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ferric pyrophosphate citrate

Other studies in this condition

Anemia →

Other studies from this sponsor

Rockwell Medical Technologies, Inc.

Start the discussion