NCT02595437

Triferic Pediatric Pharmacokinetic Protocol

Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Via Dialysate and IV to Pediatric Patients on Chronic Hemodialysis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Rockwell Medical Technologies, Inc. · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, two-period sequential dosing study.

Detailed description

This is a Phase 1/2, open-label, 2-period, single-dose study assessing the safety and pharmacokinetics (PK) of Triferic (ferric pyrophosphate citrate, or FPC) administered via dialysate and IV to pediatric patients (\< 18 years of age) receiving chronic hemodialysis (CKD-5HD). Total participation in the study is approximately three weeks and is comprised of a screening visit, two dosing (PK) visits, and a follow-up visit. Each patient will receive a single dose of Triferic administered IV into the venous blood return line over the duration of the dialysis. At the next scheduled dialysis session each patient will receive a single dose of Triferic administered via dialysate during a single hemodialysis session. Blood samples will be obtained at various times to analyze for serum iron parameters and for safety.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Triferic

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2015-11-03
• Last updated: 2018-10-25
• Results posted: 2018-10-25

Locations

9 sites across 1 country: United States