Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis

NCT02909153 | Completed Phase 1 Results

• 1 other identifier: RMFPC-17
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Peritoneal Dialysis (PD); Anemia; Chronic Kidney Disease

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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).

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

• 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).

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

• 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).

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

• 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).

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

• 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).

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

• 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).

  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)

  12 hours

Study Arms (2)

single dose of Triferic in the peritoneal dialysis solution

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Triferic DRUG

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

single IV dose of Triferic 6.6 mg over a 4 hour period; single dose of Triferic in the peritoneal dialysis solution

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The patient must be 18-75 years of age inclusive at the time of consent.
• 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.
• 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
• Have a blood hemoglobin concentration above 9.5 g/dL.
• Have a total iron binding capacity (TIBC) of ≥ 175 µg/dL.
• Have not experienced peritonitis episodes in the last 3 months prior to Screening.
• The patient must agree to discontinue all iron preparations for 14 days prior to Study PD #1/Day 1.
• 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.

You may not qualify if:

• The patient has had an red blood cell (RBC) or whole blood transfusion within 4 weeks prior to Screening.
• 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.
• The patient has known active bleeding from any site (e.g., gastrointestinal, hemorrhoid, nasal, pulmonary, etc.).
• 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.)
• The patient is scheduled to have a surgical procedure during the study.
• 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.
• The patient has a history of noncompliance with the dialysis regimen in the opinion of the Investigator.
• 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.
• 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.)
• 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.
• The patient is known to be positive for HIV, hepatitis B, or hepatitis C (viral testing is not required as part of this protocol).
• 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).
• 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.
• The patient currently has any malignancy other than basal or squamous cell skin cancer.
• The patient has a history of drug or alcohol abuse within the 6 months prior to Screening.

Sponsors & Collaborators

• Rockwell Medical Technologies, Inc.: lead

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

ferric pyrophosphate; spleen fibrinolytic proteinase (human)

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: clinical project manager
• Organization: Rockwell Medical

sgrimberg@rockwellmed.com

248-960-9009

Study Officials

• Raymond D Pratt, MD, FACP

  Rockwell Medical, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 21, 2016
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 8, 2019
• Results First Posted: August 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share