Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis
Condition: Peritoneal Dialysis (PD); Anemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Triferic
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Triferic; ferric pyrophosphate citrate (FPC); peritoneal dialysis; anemia; chronic kidney disease

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.
    

Eligibility criteria:

        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:

          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.