Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rockwell Medical Technologies, Inc.
• Treatments: Citric Acid; Dialysis Solutions; Iron

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.