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Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis

2016-09-21 20:23:22 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Peritoneal Dialysis (PD)

Intervention

Triferic

Status

Not yet recruiting

Source

Rockwell Medical Technologies, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-21T20:23:22-0400

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Portable peritoneal dialysis using the continuous (24 hours a day, 7 days a week) presence of peritoneal dialysis solution in the peritoneal cavity except for periods of drainage and instillation of fresh solution.

Dialysis fluid being introduced into and removed from the peritoneal cavity as either a continuous or an intermittent procedure.

Therapy for the insufficient cleansing of the BLOOD by the kidneys based on dialysis and including hemodialysis, PERITONEAL DIALYSIS, and HEMODIAFILTRATION.

Disorder characterized by a wide range of structural changes in PERITONEUM, resulting from fibrogenic or inflammatory processes. Peritoneal fibrosis is a common complication in patients receiving PERITONEAL DIALYSIS and contributes to its gradual decrease in efficiency.

Natural openings in the subdiaphragmatic lymphatic plexus in the PERITONEUM, delimited by adjacent mesothelial cells. Peritoneal stomata constitute the principal pathways for the drainage of intraperitoneal contents from the PERITONEAL CAVITY to the LYMPHATIC SYSTEM.

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