A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection

Shire

Status and phase: Completed; Phase 2

Conditions: Graft Rejection

Treatments: Biological: C1 Esterase Inhibitor (Human); Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01147302

2012-000441-12 (EudraCT Number)

0624-201

Details and patient eligibility

About

The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1 Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated Rejection (AMR).

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria include:

• ≥18 years of age.
• Weigh ≥50 kg.
• Donor specific antibody identified.

Exclusion Criteria include:

• Any surgical or medical condition that could interfere with the administration of study drug or interpretation of study results.
• History of allergic reaction to C1 Esterase Inhibitor or other blood products.
• Participation in the active dosing phase of any other investigational drug study within 30 days prior to dosing with study drug.
• Pregnancy or lactation.
• Receipt of any experimental agents for AMR within 1 month prior to the first dose of study drug.
• Any infection that causes hemodynamic compromise.
• History of bleeding or clotting abnormality.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

18 participants in 2 patient groups, including a placebo group

C1 Esterase Inhibitor (Human)

Experimental group

Description:

Subjects were to receive C1 esterase inhibitor intravenously at a rate of approximately 1 mL per minute as tolerated. Subjects were to receive a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13

Treatment:

Biological: C1 Esterase Inhibitor (Human)

Normal Saline

Placebo Comparator group

Description:

placebo infused as above

Treatment:

Biological: Placebo