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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-24

Study Completion Date

2013-06-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Graft Rejection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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C1 Esterase Inhibitor (Human)

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

Group Type EXPERIMENTAL

C1 Esterase Inhibitor (Human)

Intervention Type BIOLOGICAL

Normal Saline

placebo infused as above

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Interventions

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Placebo

Intervention Type BIOLOGICAL

C1 Esterase Inhibitor (Human)

Intervention Type BIOLOGICAL

Other Intervention Names

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C1 INH-nf

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No