A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients

End Stage Renal Disease Clinical Trial

Official title:

A Randomized 3 Period Crossover Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04042324
• Other study ID #: RMFPC-24
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 30, 2019
• Est. completion date: January 16, 2020

Study information

• Verified date: November 2020
• Source: Rockwell Medical Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the effect of co-administration of Triferic and heparin on the ability to maintain circuit anti-coagulation and iron delivery when compared to control conditions when each treatment is administered via separate routes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 16, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult hemodialysis patients =18 years of age.

2. Signed informed consent to participate in the study.

3. Stable on hemodialysis prescription for =3 months.

4. Hemoglobin concentration >9.5 g/dL.

5. Serum TSAT =20%.

6. Able to receive continuous heparin infusion as their anticoagulation protocol.

7. Receiving hemodialysis via AV (arteriovenous) fistula or graft.

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

Exclusion Criteria:

1. Active bleeding disorder (GI, skin, nasal…)

2. Receiving hemodialysis via catheter.

3. Receiving heparin free dialysis.

4. Receiving low molecular weight heparin as sole anti-coagulation for dialysis.

5. Receiving IV iron within 2 weeks of the first on-study hemodialysis treatment.

6. Receiving oral anti-coagulants or anti-platelet agents.

7. Any other condition, that in the opinion of the investigator would not allow completion of the 3 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.
• Heparin
Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.

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	Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t		8 hours
Secondary	Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours		4 hours
Secondary	aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours		4 hours
Secondary	TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours		4 hours
Secondary	Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration)		8 hours
Secondary	Iron Profile as Measured by the AUC (Area Under the Curve) 0-t		8 hours