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

NCT04042324 | Completed Phase 1 Results FDA Drug

• 1 other identifier: RMFPC-24
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t

  8 hours

Secondary Outcomes (5)

• Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours

  4 hours

• aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours

  4 hours

• TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours

  4 hours

• Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration)

  8 hours

• Iron Profile as Measured by the AUC (Area Under the Curve) 0-t

  8 hours

Study Arms (3)

Triferic post-dialyzer; UFH via continuous infusion

EXPERIMENTAL

Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis.

Drug: Triferic; Drug: Heparin

UFH and Triferic admixture

EXPERIMENTAL

Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis.

Drug: Triferic; Drug: Heparin

UFH via continuous infusion pre-dialyzer

EXPERIMENTAL

Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis

Drug: Heparin

Interventions

Triferic DRUG

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

Also known as: ferric pyrophosphate citrate, FPC

Triferic post-dialyzer; UFH via continuous infusion; UFH and Triferic admixture

Heparin DRUG

Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.

Also known as: Unfractionated heparin, UFH

Triferic post-dialyzer; UFH via continuous infusion; UFH and Triferic admixture; UFH via continuous infusion pre-dialyzer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult hemodialysis patients ≥18 years of age.
• Signed informed consent to participate in the study.
• Stable on hemodialysis prescription for ≥3 months.
• Hemoglobin concentration \>9.5 g/dL.
• Serum TSAT ≥20%.
• Able to receive continuous heparin infusion as their anticoagulation protocol.
• Receiving hemodialysis via AV (arteriovenous) fistula or graft.
• Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.

You may not qualify if:

• Active bleeding disorder (GI, skin, nasal…)
• Receiving hemodialysis via catheter.
• Receiving heparin free dialysis.
• Receiving low molecular weight heparin as sole anti-coagulation for dialysis.
• Receiving IV iron within 2 weeks of the first on-study hemodialysis treatment.
• Receiving oral anti-coagulants or anti-platelet agents.
• Any other condition, that in the opinion of the investigator would not allow completion of the 3 hemodialysis treatments in the study.

Sponsors & Collaborators

• Rockwell Medical Technologies, Inc.: lead

Study Sites (1)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

ferric pyrophosphate; spleen fibrinolytic proteinase (human); Heparin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Raymond Pratt, MD
• Organization: Rockwell Medical, Inc

rpratt@rockwellmed.com

248 960 9009

Study Officials

• Raymond Pratt, MD

  Rockwell Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: August 1, 2019
• Study Start: September 30, 2019
• Primary Completion: January 16, 2020
• Study Completion: January 16, 2020
• Last Updated: December 2, 2020
• Results First Posted: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)