Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.

End Stage Renal Disease Clinical Trial

Official title:

A Randomized 4 Period Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409132
• Other study ID #: RMFPC-26
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 25, 2020
• Est. completion date: April 2, 2021

Study information

• Verified date: April 2021
• Source: Rockwell Medical Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the administration of Triferic AVNU intravenously by three different administration schedules compared to continuous infusion over 3 hours

Description:

An open-label, randomized, four period sequential study of Triferic AVNU administered intravenously by three different administration schedules compared to continuous infusion over 3 hours

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2, 2021
• Est. primary completion date: April 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult hemodialysis patients =18 years of age.

• Signed informed consent to participate in the study.

• Stable on hemodialysis prescription for =3 months.

• Able to sustain hemodialysis 3x/week for 3 to 4 hours.

• Hemoglobin concentration >9.5 g/dL.

• Serum TSAT =20%.

• Receiving hemodialysis via AV fistula or graft.

• Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.

• Able to receive intermittent heparin administration for anticoagulation of the dialysis circuit.

• Serum TIBC = 150 µg/dL.

Exclusion Criteria:

• Active bleeding disorder (GI, skin, nasal…)

• Receiving hemodialysis via catheter.

• Receiving IV iron within 10 days of the first on-study hemodialysis treatment.

• Receiving oral iron within 10 days of the first on-study hemodialysis treatment.

• Any other condition, that in the opinion of the investigator would not allow completion of the 4 hemodialysis treatments in the study.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Triferic
Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.

Locations

Country	Name	City	State
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Rockwell Medical Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D		8 hours
Primary	Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D		8 hours
Secondary	Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D		8 hours
Secondary	Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D		8 hours
Secondary	Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D		8 hours
Secondary	Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D		8 hours